National Advisory Council on Alcohol Abuse and Alcoholism | NIAAA

Presented by Mark Egli, Ph.D.

May 13, 2025

Purpose

This request is to renew the concept for the Integrative Neuroscience Initiative on Alcoholism (INIA), starting Fiscal Year 2027. The INIA consortium will support two collaborative research consortia through an open competition to study brain-body homeostatic dysregulation that promotes and perpetuates excessive alcohol drinking and related Alcohol Use Disorder (AUD) phenotypes.

Scope

We encourage hypothesis-centered research on interactions between alcohol and other relevant causal influences. Focus on trajectories from initial alcohol exposure to the development of pathological drinking by some individuals will identify translatable markers and mechanisms to support future prevention and intervention efforts that reduce the chronic conditions associated with alcohol misuse including but not limited to AUD. To promote innovation, investigators will adapt advanced tools and technologies from the BRAIN Initiative, NIH Common Fund, and other sources to examine brain structure and function at multiple spatial and temporal scales, from microcircuitry to whole brain
networks, and reveal peripheral influences on brain function underlying excessive alcohol drinking. To promote rigor and reproducibility, a focus on standardization of neurofunctional measures and replication will be instituted across both consortia. In the context of the initiative, integration occurs with: (1) projects across multiple participating
sites addressing objectives around a central hypothesis, (2) knowledge of actions and interactions at multiple biological scales of analysis, (3) shared resources and standardized experimental protocols, and (4) cross-species translation.

Grant Mechanism

The initiative renewal will support two collaborating multisite consortia though cooperative agreement mechanisms, each comprised of administrative and resource cores, and U01s for individual research projects.

Presented by Shailesh Kumar, Ph.D.

May 13, 2025

Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) launched the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) in 2012 to determine how adolescent alcohol-related disruption of normal brain growth patterns of structure, related brain function, and psychiatric health affects brain functioning in emerging adulthood.

Scope

The consortium uses an accelerated longitudinal design and has acquired data on over 800 individuals between the ages of 12 to 32 years. This wide age range covers the period before onset of drinking, the transition from adolescence to young adulthood, the critical period for binge drinking, and the time of maturing out. This unique dataset provides novel information on the enduring and transient consequences of adolescent drinking on adult brain function and behavior. Current studies on adults drinking do not have this type of data. Renewal of this limited competition NOFO will enable NCANDA to continue to follow these participants up to 37 years of age and acquire data critical to understanding how early versus late onset drinking during adolescence differentially impacts drinking behavior in adulthood. This limited competition renewal will provide valuable information for developing evidence-based alcohol prevention strategies and early intervention approaches to prevent the progression to more severe drinking and AUD thereby preventing the development of chronic disease, improving health outcomes, and increasing quality of life and longevity.

Grant Mechanism

The organizational structure under the new announcement will remain the same. The Administrative Resource Core and Data Analysis Core will fall under the U24 mechanism, while Research Sites will use the U01 mechanism.

Presented by Robert Freeman, Ph.D.

September 12, 2024

Purpose

As a known disinhibitor, alcohol can be part of a lethal mix when consumed in proximity to unstored and/or unlocked firearms. The obvious difficulty involved in intervening in real time in an impulsive, alcohol- and firearm-related suicide attempt suggests the benefits of an alcohol sensor device for firearms that can prevent firearm activation by an individual with a detectable blood alcohol concentration (BAC) above an established limit (e.g., driving while intoxicated, driving under the influence).  

Similarly, such a sensor device might enhance the safe storage of firearms by blocking the opening of a firearm storage unit when the sensor detects that the individual’s BAC level exceeds an established acceptable limit. Some research indicates that firearms owners prefer that their firearms remain loaded and unlocked at home, as personal protection is often their main reason for owning a firearm. Indeed, the U.S. Centers for Disease Control and Prevention and the U.S. Department of Veterans Affairs have endorsed several firearms safety technologies—including lock boxes, gun cases, and gun safes—but gun locks and safes can be opened by an individual who is under the influence of alcohol. Hence, this announcement in response to a call for SBIR contracts research topics for the PHS 2025 Small Business Innovation Research (SBIR) Contract Solicitation also seeks proposals for the development of alcohol sensors for firearm storage spaces such as lock boxes and gun safes.

Firearm injury caused 45,222 deaths in the United States in 2020; nearly 54% of these were suicides. The firearm homicide rate increased 33.4% between 2019 and ’20, and firearm-related injury was the leading cause of death for U.S. youth ages 1–19. The U.S. suicide rate by firearm has increased by 19% over the past decade, while rates of suicide by firearm increased by approximately 15% among youths and young adults between 2019 and 2020. In addition to deaths, many more Americans experience nonfatal firearm injuries that substantially impact their lives.

While suicide is famously multiply determined, it is difficult to overlook the outsized role of alcohol use disorder (AUD) diagnosis and heavy alcohol use in suicidal thoughts and behaviors (STBs). For instance, in a study of VA users in 2005-6, an AUD diagnosis was associated with a hazard ratio for death by suicide of 2.21 (2.06, 2.38) in men and 3.73 (2.48, 5.62) in women after controlling for demographic factors and co-occurring psychopathology. Furthermore, acute use of alcohol has been identified as a potent near-term risk factor for suicidal behavior, as some research suggests that it is correlated with increases in subsequent-hour intensity of suicidal ideation across the 24 hours prior to a medically-attended attempt.

This call for SBIR contract proposals follows a number of recent NIH efforts aimed at stimulating public health-oriented research focused on the reduction of firearms violence. Indeed, although NIH has supported violence research for decades, growing attention on the public health impact of firearm violence has led to a significant increase in investment in recent years. The Further Consolidated Appropriations Act of 2020, the Consolidated Appropriations Act of 2021, and the Consolidated Appropriations Act of 2022 provided $12.5 million to the NIH each year in support of research on firearm injury and mortality prevention by taking a comprehensive approach to studying the underlying causes of firearm injury and investigating evidence-based methods of prevention. Language in these acts stipulated that the funded research must be ideologically and politically unbiased and that funds could not be used to promote gun control. Subsequently, NIH released Notices of Funding Opportunities (NOFOs) in 2020 and 2021 for the purpose of building upon NIH’s existing violence research portfolio and to address emerging areas in violence research. These NOFOs solicited applications proposing research to improve understanding of the determinants of firearm injury, identification of those at risk of firearm injury, and the development and evaluation of innovative interventions to prevent firearm injury and mortality. In response to these NOFOs, NIH supported 9 awards in 2020 and 10 awards in 2021 for firearm violence prevention research. In addition, NIH established The Community Firearm Violence Prevention Network, a NIH-supported community-academic research collaboration—consisting of a Coordinating Center, Steering Committee, and multiple research projects—that works to prevent firearm violence across the U.S. through developing, implementing, and evaluating innovative community-based interventions.

Scope/Objectives

The overarching goal of the work to be supported by this proposed initiative is to develop an alcohol-activated locking system for firearms and/or firearm storage units. Projects may choose to develop devices for either firearms or for firearm storage units, or for both. The devices outlined here can be seen as analogous to ignition interlock devices—small devices that connect to a vehicle’s ignition system and measure the driver’s breath alcohol level—that prevent the driver from starting the vehicle until a breath alcohol test has been taken. Installation of such a device is a common requirement following a drunk driving offense.

Projects in response to this NOFO should first develop a functioning prototype for an alcohol-activated locking system for firearms and/or firearm storage units. Projects should initially establish clinical performance for the device(s). Applicants can propose modifying or simplifying an existing device—such as an ignition interlock device—so that it can be used in the role described in this announcement, or add new features to an existing device to enable it to operate as an alcohol-activated locking system for firearms and/or firearm storage units; and/or apply emerging technologies that have not been previously used for an alcohol-activated locking system for firearms and/or firearm storage units. Supported work includes both the development of the device as well as approaches for reducing user burden and simplifying training needs for its use.

Supported activities should include design and usability studies that include minimally-trained individuals drawn from the community. The technology must comply with the applicable regulations and international standards/guidelines such as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) as well as any local regulations that may apply.

Investigators must explicitly consider affordability and cost-effectiveness design criteria for technologies proposed in applications responding to this NOFO. Technologies should be sustainable and affordable (either low enough in cost to easily replace, easily replaceable parts/ease of repair, or durability).

Outcome/Justification

This proposed addition to the list of SBIR contracts research topics for the PHS 2025 Contract Solicitation ultimately seeks to generate contract proposals that propose the development of the BAC-sensitive trigger lock devices described here. These could represent a significant advance in suicide and, potentially, homicide prevention. Such alcohol sensor- enhanced devices for firearms and firearms storage units may be deemed acceptable and feasible by those people who wish to be able to keep their firearms, who understand that an elevated BAC level is associated with impaired decision-making, accidents and injuries, and who understand that such technologies can successfully prevent the use of a firearm by a person under the influence of alcohol. Moreover, it may be understood, by potential purchasers, that these technologies promote the safe storage of firearms in the home, vehicle, or other setting, which may be an especially valuable feature for households with children and adolescents.

Finally, at the population level, in light of the acknowledged strong relationship between alcohol misuse and suicide, it should be recognized that such an initiative is likely to have utility in confronting the epidemic of alcohol-related suicide in the United States.

Presented by Mohammed Akbar, Ph.D.

September 12, 2024

Purpose

The goal of the Neurobiology of Adolescent Drinking in Adulthood (NADIA) consortium is to elucidate persistent changes in brain-behavior relationships following adolescent alcohol exposure. The initiative supports research across different research institutions to investigate the consequences of repeated adolescent alcohol exposure on brain maturation and adult outcomes. Based on the progress shown by the NADIA investigators, we recommend continuing the consortium through a set of cooperative agreement (U) awards.

Background

Adolescent alcohol misuse is common between the ages of 19 and 25; and 13.8% of all alcohol consumed in the United States is by 12-20 year olds1. In 2022, 5.8 million young people reported consuming alcohol beyond “just a few sips,” 5.1 million reported binge drinking, and 3.2 million reported binge drinking on five or more days over the past month2. High alcohol consumption can lead to serious long-term consequences, including the development of alcohol use disorder (AUD). Data from the National Consortium on Alcohol and Neurodevelopment in

Adolescence (NCANDA) has shown the negative effects of binge drinking on the developing brain as well as decreases in cortical gray matter volume when measured in close proximity to binge drinking episodes. These effects of alcohol were dose-dependent suggesting a causal effect. It will be interesting to determine if normal growth trajectories may be reinstated with alcohol abstinence. To understand structural and functional brain impairments that persist or recover over the course of brain maturation, it is important to investigate the neurobiology of adolescent alcohol exposure experimentally with a special focus on the molecular, cellular, and circuit mechanisms underlying behavior changes, and to interpret and translate these findings in the context of humans who misuse alcohol during adolescence.

Scope/Objectives

Research objectives for the renewal include, but are not limited to:

• Mechanistic understanding of the persistent molecular, cellular, and neurocircuitry and sex-specific changes in the adult brain as consequences of adolescent alcohol exposure.
• Identifying effects of early vs late adolescent alcohol exposure on adult brain structure and function.
• Discovering molecular mechanisms for prevention/reversal experiments to restore neurocircuit and epigenetic changes in adults after adolescent alcohol exposure.
• Identifying translational endpoints such as key genes, epigenetic modifications, behavioral tasks, or physiological measures that will inform human studies in the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA).

Future Directions

Areas of research appropriate to this announcement include, but are not limited to:

• Transition early career scientists currently contributing as co-investigators into leadership roles as PIs.
• Maintain data elements, dissemination approaches and NIH-compliant data sharing infrastructure to support secondary analyses (e.g., mediation analysis and artificial intelligence mining) focusing on mechanisms of adolescent alcohol-exposure effects.
• Promote integration and translation through appropriate hypotheses and phenotypic measures  to inform research and interventions in humans, and support collaborations and publications with NCANDA scientists who are investigating alcohol exposure effects on neurodevelopment in humans.
• Consider the impact of adolescent alcohol exposure on sensory, affective, cognitive and behavioral phenotypes relevant to AUD such as pain conditions and hyperalgesia, negative affect, stress regulation, and social functioning.
• Identify persistent and transient neurobiological consequences of adolescent alcohol exposure arising from extra neuronal sources such as microglia, astrocytes, extracellular matrix and perineuronal nets (PNNs), and their associated mechanisms.
• Mechanism-based delineation of time-periods associated with vulnerability to insult and therapeutic time-windows.
• Investigating the underlying mechanisms of observed sex effects of adolescent alcohol exposure.

Justification

The NADIA Consortium has discovered epigenetic mechanisms leading to persistent changes in neuronal, astrocyte, and microglial cells that vary across brain regions, impacting large brain networks, particularly the salience network, forebrain cholinergic neurons, astrocytes and microglial cells. Similarly, NADIA’s discoveries of epigenetic mechanisms causing persistent adult psychopathology are supported by reversal-restoration studies that bring promise for novel therapeutic targets. By fostering integration, the NADIA consortium will significantly escalate the acquisition of knowledge and the translation of research findings to the human condition. In the renewal we will support additional work to uncover mechanisms of recovered brain function impaired by adolescent alcohol exposure and explore translational implications through ongoing collaboration with NCANDA  consortium investigators and others studying effects of alcohol exposure on neurodevelopment in humans.

References

• Substance Abuse and Mental Health Services Agency (SAMHSA), Center for Behavioral Health Statistics and Quality (CBHSQ) [Internet]. 2022 National Survey on Drug Use and Health. from: https://www.samhsa.gov/data/sites/default/files/reports/rpt42728/NSDUHDetailedTabs2022/NSDUHDetailedTabs2022/NSDUHDetTabsSect2pe2022.htm#tab2.8b
• SAMHSA, CBHSQ [Internet]. 2022 National Survey on Drug Use and Health. from: https://www.samhsa.gov/data/sites/default/files/reports/rpt42728/NSDUHDetailedTabs2022/NSDUHDetailedTabs2022/NSDUHDetTabs2-44and2-45pe2022.pdf.
• Adolescent Binge Drinking Is Associated With Accelerated Decline of Gray Matter Volume M (2022). Infante MA, Eberson SC, Zhang Y, BrumbackT, Brown SA, Colrain IM, Baker FC, Clark DB, De Bellis MD, Goldston D, Nagel BJ, Nooner KB, Zhao Q, Pohl KM, Sullivan EV, Pfefferbaum A, Tapert SF, Thompson WK. Cerebral Cortex, Volume 32, Issue 12, 15 June 2022, Pages 2611–2620, https://doi.org/10.1093/cercor/bhab368

Presented by Laura Kwako, Ph.D.

September 12, 2024

Purpose

This concept will use an R25 (Research Education) mechanism to address gaps in knowledge about alcohol among young adults in college/university and community settings. This goal will be achieved by developing “NIAAA Champions,” individuals and organizations that can act as advocates for advancing evidence-based information about alcohol and its impacts on health and well-being.  While there are multiple potential paths towards this goal, the overarching mission is to improve the culture of alcohol consumption in college and universities across the U.S., ultimately reducing alcohol-associated harms in these settings, with particular attention to improving health equity.

Scope/Objectives

The R25 mechanism supports research education activities, in this case, to foster a better understanding of biomedical, behavioral, and clinical research about alcohol and the implications of this research for young adults in various settings. This Research Education Program will support rigorous, community-tailored educational outreach with concentration on the development of: (1) community needs assessment and landscape analysis to identify specific educational gaps in fundamental information pertaining to alcohol, e.g., standard drink sizes, influence of alcohol on behavior, impact of alcohol on mental health, (2) infrastructure for coordinated implementation of an educational outreach program focused on alcohol prevention and harm reduction, (3) evidence-based health resources to improve awareness of the impacts of alcohol misuse, (4) evidence-based health information tools to improve campus connections to AUD health services, (5) program evaluation of harm reduction and outreach efforts, particularly among communities experiencing health disparities, (6) programs to recruit and train cohorts of students and young people to facilitate educational outreach and disseminate information in local communities, and (7) community outreach education sustainability plans, in collaboration with community partners.

Justification

Young adults in the U.S. consume alcohol at high rates, including frequent binge and heavy drinking.  Specifically, results from the 2022 National Survey on Drug Use and Health (NSDUH) on past month alcohol consumption among individuals between the ages of 18 and 25 years found that 49.6% drank alcohol, 28.7% reported binge drinking and 6.9% reported heavy drinking.  The 2023 Monitoring the Future study found that approximately 7% of this population reported high-intensity drinking (10+ drinks in a row) over the two weeks prior to survey.  Thus, improving awareness of available treatments, increasing prevention, and building sustainable infrastructure to reduce alcohol misuse in college and university and community settings is of critical importance.

Presented by Robert Freeman, Ph.D.

September 12, 2024

Purpose

Proposed is a program announcement calling for research applications that use the principles and methods of Community-Based Participatory Research (CBPR) in proposing a program of preventive screening and intervention for heavy drinking and alcohol use disorder (AUD) in health disparity and socioeconomically disadvantaged communities. Such an approach builds upon, and draws liberally from, the so-called “barbershop” prevention model that uses barbershops as venues for prevention interventions owing to their demonstrated capacity to reach African American men, in particular. Indeed, a growing research literature has demonstrated that barbershop-based preventive interventions—located in settings regarded as “safe places” where Black men can gather and discuss a variety of sensitive topics—are effective in promoting health, preventing disease, and in treating chronic conditions, including hypertension, sexually transmitted infections/HIV prevention, screening for colorectal cancer, and in encouraging smoking cessation and increasing fruit and vegetable intake.

While the “barbershop” model has been less studied as a venue for promoting screening, brief intervention and referral for treatment for alcohol misuse/AUD, the time seems right to advance this type of prevention approach for harmful drinking/AUD in health disparity and socioeconomically disadvantaged communities. U.S. Centers for Disease Control and Prevention data indicate that only 1 in 6 U.S. adults report that they have ever discussed their alcohol use with a health professional while, importantly, the population groups that are the focus of this notice of funding opportunity (NOFO) reportedly receive screening for high-risk drinking/AUD less often—and less thoroughly—than does the U.S. white population. Increasing the low levels of alcohol screening reported by these communities can help to reduce racial health disparities.

Scope/Objectives

• Applications under the proposed NOFO are not obligated to use the barbershop setting as a venue for prevention activities, but may also consider such community establishments as beauty parlors, betting parlors, health clubs, gyms, recreational centers, laundromats, tattoo parlors, and churches.
• In addition, applications under this NOFO may focus on one of a number of racial/ethnic and socioeconomic communities. For the purpose of this NOFO, a “community” refers to a population that may be defined by geography, race, ethnicity, culture, gender, illness or other health condition. Communities must include significant representation of one or more NIH-designated U.S. health disparity populations, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations and rural populations.
• While it is expected that applicant teams will propose alcohol screening as a first step in identifying individuals engaging in high-risk drinking behaviors, applicants are free to choose the degree to which they wish to employ the full screening, brief intervention and referral to treatment (SBIRT) intervention model. While NIAAA is interested in multilevel interventions that involve a combination of individual, group, and community-level components, NIAAA also understands that adherence to the principles of a CBPR approach strongly dictates that the community, itself, will be instrumental in choosing the preferred preventive intervention approach.
• Projects will be required to involve at least one community-based organization, either as the applicant organization or a partner organization. The individual or representative of the community organization will be named among key personnel in the Notice of Grant award.
• This program expects to utilize the R01, U01 and R61/R33 funding mechanisms.

Justification

The purpose of the proposed NOFO is to support promising community screening and intervention approaches for alcohol misuse/AUD using CBPR principles that are located in health disparity and socioeconomically disadvantaged communities, with the ultimate aim of reducing and eventually eliminating health disparities.

Presented by Elizabeth Powell, Ph.D.

February 08, 2024

Purpose

The purpose of the Collaborative Study on the Genetics of Alcoholism (COGA) is to advance knowledge about the complex influences of gene and environment on development and progression of alcohol use disorder (AUD). From its inception, COGA has generated and utilized extensive arrays of genotypic and phenotypic data from families densely affected by AUD and from comparison families to identify genes and understand their role in susceptibility to (or protection from) developing AUD and related phenotypes. New genetic variants have been identified, refined endophenotypes have been characterized, and functional information has begun to emerge on known genetic variants that influence risk for and protection from AUD. 

The goals of this renewal concept are to continue to integrate and share COGA data and to continue to add data across the lifecycle, specifically in the adolescent and young adult (Prospective Study) and older adult (Lifespan Study) cohorts. The initiative will advance the understanding of the complexity of the genotypes and phenotypes that contribute to the heterogeneity of AUD, integrate the analysis of multiple data sources, and generate mechanistic hypothesis to understand the contributions of genetic, behavioral, and environmental factors on the development of (or resilience from) AUD.

Scope/Objectives

The scope of the concept is to understand how previously identified genes and gene variants act to affect the risk for AUD or support recovery in current COGA cohorts, particularly the studies on adolescent and young adults in Prospective Study and on older subjects (participants 50+ years in the Lifespan Study). Examination of the influences of environmental factors continues to be essential for delineating the heterogeneity and underlying biological mechanisms of AUD phenotypes. This initiative is expected to:

• Advance the understanding of the complexity of AUD leveraging existing multi-generational COGA genetic and genomic data, including utilizing state-of-the-art genomic, epigenomic and multi-omic technologies, such as WGS (whole genome sequencing), RNA-seq, methylome, metabolome, and proteome analyses.
• Identify genes with a causal role in AUD based on genome-wide significant loci from genome-wide association studies.
• Generate of a web-based portal to make COGA research findings and publications accessible to the scientific community and to communicate the key COGA findings with public health implications and relevance to the public.
• Share all past and new COGA genetic and genomic data with related comprehensive phenotypic data widely with the broader research community.
• Establish an integrated COGA database resource for a wide variety of analyses that is available to researchers interested in AUD. The resource will include basic processing, harmonization, imputation, and integration of multi-modal past and new COGA datasets, so that data are FAIR (Findable, Accessible, Interoperable and Reusable).
• Generate tools and methodology, in collaboration with geneticists and data scientists, to perform current, integrative, comprehensive analyses leveraging the entire COGA and other large-scale datasets (e.g. genetics and genomics, transcriptomics, and epigenomics) across the alcohol addiction cycle and life cycle, providing mechanistic hypotheses for follow-up studies.
• Provide biological reagents and bioinformatic analysis tools to researchers outside of COGA.
• Facilitate the field to move from identification of genetic loci to understanding mechanisms underlying chronic AUD and associated comorbidities (using functional genomics approaches, and social-environmental contributions).
• Develop an integrated model of risk, resilience, and recovery of AUD that includes genomic, physiological, and socio-environmental factors over the lifespan.
• Continue to collect genetic and phenotype data on COGA adolescents and young adults and aging families focusing on the understudied period of later life to investigate lifespan perspective. This includes longitudinal course of chronic AUD through late life, and medical, neurocognitive, and mental health correlates and consequences of AUD (including cognitive decline, dementia, liver disease, premature death and other medical and mental health comorbidities).

Justification

The previous COGA studies have provided critical information to better understand the genetic and biological underpinnings of AUD. However, there is a need for a framework to unify the findings and provide the data to the community for additional analysis and discovery. The initiative will facilitate identification of therapeutic targets and development of prevention strategies for AUD, supported by data generation, curation and bioinformatic analyses. The environment for data sharing has changed dramatically in the past 5 years. The establishment of the NIAAA Data Archive and the Final NIH Data Management and Sharing Policy (NOT-OD-21-013) provide an ecosystem and structure for the sharing of future and past (legacy) data from the COGA studies. The initiative will require analysis of all the COGA results. While the adult data in COGA are extensive, two family cohorts, adolescent and young adults in Prospective Study and older participants in Lifespan Study, will benefit from additional participants and data collection. The COGA initiative is focused on optimizing the use of the past COGA data and completing data collection across the lifespan. New pilot studies or experimental directions are not anticipated.

Presented by Kendall Bryant, Ph.D.

September 07, 2023

Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports a broad-based Alcohol Research Centers program to foster and conduct interdisciplinary, collaborative research on the effects of varied patterns of alcohol use and associated alcohol use disorders and the broad impact of alcohol on health and disease at the individual, group, and societal levels. This NOFO uses the NIH Comprehensive Research Center (P60) mechanism to support research center grants to conduct a range of basic and behavioral cross-cutting, intervention, and translational research in alcohol and HIV/AIDS.

Background

NIAAA seeks applications aimed to address the impact of alcohol use on the most important challenges for ending HIV/AIDS pandemic. These priority areas include: 1) Reducing incidence of HIV/AIDS including testing vaccine efficacy and delivery of effective infection preventive interventions; 2) Developing and testing the next generation of HIV therapies among alcohol and other substance users; 3) Research toward a cure – and an increased understanding of viral reservoirs and viral dynamics influenced by different patterns of alcohol use; 4) Addressing the impact of comorbidities, coinfections, and complications (including alcohol-related comorbidities such as depression, anxiety, pain, trauma, other substances, and potentially interactive medications) in the context of an aging population of individuals living with HIV; 5) cross-cutting integrative areas of basic biological and behavioral research on fundamental issues that underpin the development of high priority HIV prevention and treatment strategies; 6) research to reduce health disparities, and research training of workforce required to conduct high priority HIV/AIDS and alcohol related research. Of particular importance is the training of early-stage investigators.

Scope/Objectives

Given the significant overlap between alcohol use-associated susceptibility of infections and chronic conditions in multiple organ/systems and HIV-related comorbid conditions, research topics for the center core components may advance cross-cutting research ( https://www.oar.nih.gov/hiv-policy-and-research/research-priorities-overview/cross-cutting-research).

Basic/mechanistic studies identified as cross-cutting research are to provide the underlying foundation for all HIV research areas and include studies on HIV virology; acquisition, transmission, and susceptibility; and investigations of HIV-related immunology and host-viral interactions. Research on the viral, cellular, molecular, genetic, and immune mechanisms of pathogenesis is essential to better understand HIV acquisition, prevention, and disease progression, and the mechanisms leading to the pathogenesis of HIV-associated comorbidities, coinfections, and complications and a potential cure. Efforts must be made to ensure linkages to NIH-supported HIV cohorts, biorepositories, and other relevant databases and to potentially integrate animal studies into the discovery pipeline.

Additional Special Areas of Interest have been identified through discussions with communities of people with HIV/AIDS, practitioners, and organizational researchers. These high priority areas of research may augment other cross-cutting activities. The Office of AIDS Research (OAR) has identified several areas of particular interest that should also be considered in the context of the Comprehensive Center research activities. In response to the input received from Listening Sessions held from August 2021 through December 2022, OAR will continue to expand the efforts of multiple existing “Signature Programs” that foster collaborative research that are relevant to PWH who drink alcohol. Within each of these areas a range of alcohol-related issues could be addressed. These Programs include 1) HIV and Aging, 2) HIV and Women, and 3) Application of New Technologies of Discovery for HIV (primarily focused on biorepositories, biomarkers, and synthetic/systems biology)

Public Health Relevance/Objective: Ending the Epidemic

The U.S. Department of Health and Human Services (HHS) launched the Ending the HIV Epidemic in the U.S. (EHE) initiative in 2019. The initiative aims to reduce new HIV infections in the U.S. by 90% by 2030 by scaling up key HIV prevention and treatment strategies. This ambitious goal to end the HIV epidemic in the United States by 2030 is through the application of nearly four decades of investments in scientific research that have yielded prevention and treatment breakthroughs that now make it possible to control HIV infection. However, the role of alcohol use, and alcohol-related mental health and other substance use problems as well as environmental consequences of alcohol exposure (e.g., homelessness) exist at an individual, group, and societal level. These complex alcohol-related interconnected problems in living continue to impede this ambitious goal to End the Epidemic. Improved alcohol-focused assessment and course of HIV infection, a further understanding of impaired decision making, distribution of alcohol-related services and the implementation of effective HIV and alcohol-focused interventions at multiple levels can facilitate the achievement of EHE goals to substantially reduce new HIV infections.

Presented by Shailesh Kumar, Ph.D.

September 07, 2023

Purpose

The concept aims to explore the influence of sleep disturbance on hyperkatifeia during alcohol withdrawal. It seeks to gain a comprehensive understanding of hyperkatifeia’s features and its connection with sleep disruptions, while also developing focused interventions to alleviate symptoms, enhance emotional regulation, and improve the well-being of individuals experiencing hyperkatifeia.

Background

Alcohol induced withdrawal, a state referred to as hyperkatifeia, can be defined as hypersensitivity to emotional distress during drug withdrawal (Shurman et al., 2010). Such symptoms provide additional source of motivation for AUD through negative reinforcement. Sleep disturbances during alcohol withdrawal are part of these symptoms and contribute to discomfort and dissatisfaction. Disrupted sleep architecture, insomnia, and decreased sleep quality impair emotional regulation, awareness, and hedonic functioning, intensifying the negative emotional and motivational states. As such the sleep disturbances component of hyperkatifeia contributes to the allostatic load of addiction. Here, “allostatic load” refers to “the cost or the price the body may have to pay for being forced to adapt to an adverse or deleterious psychological or physical situation, and it represents the presence of too much demand on the operation of the regulatory systems” (Koob, and Le Moal, 2001; McEwen and Stellar, 1993). Understanding the interaction between sleep disturbances, hyperkatifeia, and AUD is crucial for developing interventions that target sleep dysfunction and improve treatment outcomes. This concept aims to provide insights into the underlying mechanisms and develop evidence-based interventions to enhance recovery, emotional regulation, and overall well-being in individuals with AUD.

Scope of Research Projects

This concept seeks to address the knowledge gap regarding the impact of sleep dysfunction on hyperkatifeia severity and treatment outcomes. By unraveling the complex interplay between sleep stages, hyperkatifeia and allostatic load, the aim is to provide evidence-based interventions that target sleep dysfunction and improve the overall well-being of individuals with AUD. The expected outcomes include an improved understanding of the neurobiological mechanisms underlying sleep disruptions, identification of therapeutic targets within the extended amygdala and its connections as well as other brain areas, and the development of interventions that alleviate hyperkatifeia symptoms, enhance emotional regulation, and improve treatment efficacy.

Research Goals

Characterize the specific disruptions in sleep stages, including non-rapid eye movement (NREM) and rapid eye movement (REM) sleep, experienced by individuals with alcohol withdrawal-induced hyperkatifeia and examine their association with hyperkatifeia severity.

Investigate the impact of altered sleep architecture on emotional dysregulation, cognitive function, and stress reactivity in individuals with AUD and hyperkatifeia.

Identify the neural circuits, neuroendocrine pathways, and brain regions involved in sleep disturbances, stress circuitry dysregulation, and hyperkatifeia to elucidate the underlying mechanisms.

Develop and refine targeted interventions that address specific sleep stage disruptions, including pharmacological approaches and behavioral interventions, that may help alleviate hyperkatifeia symptoms and improve treatment outcomes.

Research Plan

To achieve these goals, the research plan may include:

• In humans, cross-sectional and longitudinal studies to assess sleep disturbances and hyperkatifeia symptoms in individuals with alcohol withdrawal-induced hyperkatifeia.
• In humans, objective measures like polysomnography, actigraphy, and EEG, coupled with subjective assessments, to comprehensively evaluate sleep architecture, quality, and disturbances.
• In humans, neuroimaging studies (such as fMRI, fNIRS, PET) to investigate the neurobiological correlates of sleep dysfunction and hyperkatifeia, focusing on brain regions involved in emotional regulation, reward processing, and sleep-wake regulation.
• In preclinical animal models, molecular approaches to study the underlying neurobiology of sleep disturbances and hyperkatifeia by exploring neurochemical signaling pathways, genetic influences, and circuit-level interactions.
• In humans, development and refinement of evidence-based interventions targeting sleep disturbances, including pharmacological interventions and behavioral interventions such as cognitive-behavioral therapy for insomnia and sleep hygiene interventions.
• In humans, long-term follow-up assessments to examine the sustained effects of interventions on sleep outcomes, hyperkatifeia symptoms, and alcohol relapse rates in individuals with AUD.

Justification

The concept aims to address the substantial knowledge gap concerning the impact of sleep dysfunction on hyperkatifeia severity and treatment outcomes in individuals with AUD, especially during withdrawal. Despite its potential significance, this area has not been funded by the NIAAA, leaving it as an unexplored research niche (reviewed in Patterson et al 2022). Through a comprehensive study of the interplay between sleep stages, hyperkatifeia, and allostatic load, this concept aims to develop evidence-based interventions that specifically target sleep dysfunction. The ultimate goal is to improve the overall well-being of those affected by alcohol-induced hyperkatifeia. By gaining a deeper understanding of the neurobiological mechanisms underlying sleep disruptions and identifying therapeutic targets, the concept aims to alleviate hyperkatifeia symptoms, enhance emotional regulation, and significantly improve treatment efficacy. The findings from this research are essential for advancing recovery, stress regulation, and emotional well-being in individuals with alcohol withdrawal-induced hyperkatifeia.

References  

1. Shurman J, Koob GF, Gutstein HB. Opioids, pain, the brain, and hyperkatifeia: a framework for the rational use of opioids for pain. Pain Med. 2010 Jul;11(7):1092-8.
2. Koob GF, Le Moal M. Drug addiction, dysregulation of reward, and allostasis. Neuropsychopharmacology. 2001 Feb;24(2):97-129.
3. McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101.
4. Patterson JT, Koob GF, Anderson RI. Understanding Hyperkatifeia to Inform Treatment for Alcohol Use Disorder: An Assessment of the National Institute on Alcohol Abuse and Alcoholism Research Portfolio. Biol Psychiatry. 2022 Jun 15;91(12).

Presented by Elizabeth Powell, Ph.D.

September 07, 2023

Purpose

The goal is to promote data science concepts and tools in alcohol research, integrating data across disciplines and clinical and basic sciences realms.

Background

Data science has been a major focus of NIH, including the establishment of the Office for Data Science Strategy. Data science approaches have been used to make key findings in other research areas such as cancer and Parkinson’s disease research. The flood of data generated by NIAAA supported studies in genomics, imaging, electrophysiology and optogenetics, electronic health records, and personal wearable devices presents new challenges in analyses and interpretations and opportunities for discovery. Since 2019, NIAAA has required that human research data be stored in the NIAAA Data Archive (NOT-AA-23-002 for most recent notice).

Statement of Work/Project Objectives

The large databases of biological and behavioral and imaging studies supported by NIAAA provide ample information for data science approaches. However, the investigators lack the tools to participate in the data ecosystem and take advantage of current statistical and computational approaches. The state of the data science field in alcohol research has advanced only slightly since this concept was introduced in 2018. While the scope of the data is broad, many of the tools needed to answer questions in alcohol research require specific applications, algorithms or toolkits that are not currently available. This initiative is expected to:

• Generate intellectual property, analytical tools and methods for alcohol research that interface within modern data ecosystems for use by entire scientific community.
• Promote harmonization of data sets within specific disciplines of alcohol research to improve scientific reproducibility and increase sharing of data across multiple scientific teams.
• Transform fragmented sets of individual data components into a coordinated ecosystem.
• Enable multiscale analysis of clinical and basic science datasets, employ modern data science techniques of artificial intelligence, machine learning and deep learning.
• Promote interdisciplinary collaborations between neuroscientists and data scientists.
• Adapt NIH data science tools and tactics for use in alcohol research.

Justification

The volumes of data produced by NIAAA-supported research, along with publicly available databases and future results, can be analyzed using data science approaches to find new therapeutic targets and approaches for diagnosis and treatment of alcohol use disorder. Data science includes and extends beyond bioinformatics and computational neuroscience to discover new relationships and pathways for complex systems of normal human function and during adaptations due to disorders or disease. Data science is not widespread alcohol research, and thus the field is missing opportunities for discovery and treatment.

The Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) requires data sharing, yet there are limited tools and resources for combining and analyzing data from alcohol research. Since the concept was introduced in 2018, NIAAA has funded two SBIR projects for new algorithms and automated data harmonization and imputation tools. These projects are currently in Phase II. Additional tools and strategies are needed to analyze data from NIAAA research, and tools are needed to make best use of the investment in the NIAAA Data Archive.

Presented by Mark Egli, Ph.D.

May 09, 2023

Background

At least 30% of people with OUD also have AUD. Research projects dedicated to OUD treatment and prevention do not exclude subjects who drink, but seldom explicitly recruit subjects with AUD. Reciprocal relationships between opioid use and alcohol use sometimes seen in treatment contexts such that reduced opioid misuse and opioid agonist therapy tapering may result in increased drinking. Increased drinking may reflect other conditions associated with heightened opioid relapse and overdose risk.

Concept Goal

To develop an evidence base for a safe and effective arsenal of medication-assisted, psychosocial, and complementary interventions targeting distinct issues for people with OUD and AUD while considering frequently co-occurring conditions such as chronic pain and trauma exposure.

Concept Strategies

Expand subject recruitment in relevant OUD studies for greater representation of individuals with AUD to:

• Collect comprehensive data relevant to AUD in the context of ongoing OUD intervention studies
• Initiate new studies complementary to ongoing studies
• Perform secondary analysis of data from their studies or from archived data.

Current Status

The concept of Developing an Evidence Base for OUD-AUD Interventions was presented to the HEAL Multi-Disciplinary Working Group February 16, 2023, and was approved by the NIH HEAL Executive Committee

Presented by Bradley Kerridge, Ph.D.

May 09, 2023

Background

The Alcohol Epidemiologic Data System (AEDS) is a contract-funded effort in support of the NIAAA mission to provide in-house statistical analysis and programming support for use by NIAAA staff who are conducting alcohol-related epidemiologic research. The current AEDS contract is administered by CSR, Inc. and provides NIAAA staff technical support including expert statistical analysis and statistical programming to facilitate publication by NIAAA staff of secondary analyses of epidemiologic surveys and other data reports and scientific journals.

Areas of Support

The contract supports alcohol-related epidemiologic research in numerous scientific areas including but not limited to:

• Alcohol-related morbidity and mortality.
• Alcohol-related unintentional and intentional injuries.
• Alcohol screening and brief interventions.
• Alcohol-related health disparities.
• Interactions between alcohol and lifestyle risk factors including diet, exercise and smoking.

Surveillance Reports and Data Directory

AEDS Reports are well-established mechanisms by which researchers, policy makers and other interested individuals track alcohol-related information over time.  Surveillance reports on three topics are produced:

• Apparent per capita consumption of alcoholic beverages
• Liver cirrhosis mortality
• Trends in underage drinking in the United States

Samples of Surveillance Reports Produced by AEDS:

• Alcohol Sales During the COVID-19 Pandemic
• Apparent Per Capita Alcohol Consumption: National, State and Regional Trends 1977-2020
• Liver Cirrhosis Mortality in the United States: National, State, Regional Trends: 2000-2019
• Trends in Underage Drinking in the United States, 1991-2019
• Trends in Alcohol-Related Morbidity Among Community Hospital Discharges, United States 2000-2015
• Trends in Substance Use Among Reproductive-Age Females in the United States, 2002-2015

Data Directory and Storage of Reports

The Alcohol Epidemiologic Data Directory is a report that provides a current listing of surveys and other relevant data suitable for epidemiologic research on alcohol.  The contractor also warehouses hard copies of publications such as County Alcohol Problem Indicators; State Trends in Alcohol-Related Mortality; US Apparent Consumption of Alcoholic Beverages, and others.

Technical Support for Epidemiologic Research and Queries

Technical support in the form of statistical analyses and programming and scientific writing are performed to support NIAAA staff in projects that result in data-related products including data tables and in scientific manuscripts which may be published in peer-reviewed journals.

Presented by Kathy Jung, Ph.D.

February 09, 2023

Purpose

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to continue the Alcohol-associated hepatitis (AH) research program, a multi-center translational and clinical network (AlcHepNet), established in 2012 with renewal in 2018. The goal of AlcHepNet is to accelerate the discovery and validation of new diagnostic and treatment options for patients with severe AH.

The AH program achieved significant milestones and made remarkable progress in its scientific and programmatic objectives. Notable achievements include establishing consensus statements on disease definitions and common data elements, conducting impactful randomized clinical trial, and performing research studies that promote clinical trial readiness, such as natural history studies, biomarker identification and outcome measures development.

Background

AH is the most severe form of alcohol-associated liver disease prevalent in people with decades of heavy alcohol use, for which there is no FDA-approved treatments. 

The cultural attitude and beliefs surrounding AH have shifted in recent years. There is growing recognition by hepatologists that AH patients suffer from two different disorders, alcohol use disorder (AUD) and liver disease, and both disorders need to be addressed.

The recent retrospective observational studies in AH reported that participating in alcohol rehabilitation was associated with 70%–84% lower risk of 30-day hospital readmission, 89%–91% lower risk of 30-day alcohol relapse, and 80% lower risk of long-term mortality. Still, less than 8% of AH patients received alcohol relapse prevention medication.

There is a clear need for a new treatment paradigm in AH that addresses not only the patients’ liver disease but also alcohol use. However, evidence for how to guide treatment decisions is lacking and current implementation strategies vary across healthcare delivery contexts.

Scope

The proposed research concept addresses the need to treat the co-morbidities of AUD and AH. It will leverage AlcHepNet resources and capabilities to conduct multi-center and multi-disciplinary clinical trials designed to assess safety and efficacy of interventions targeting both AUD and AH simultaneously under the same infrastructure.

In order to address gaps in the AH field, this renewal concept will:

• Provide evidence that active interventions for AUD will reduce liver-related mortality in patients with AH
• Provide evidence for practical approaches (treatment duration, endpoints, outcome measures, etc.) to conduct clinical trials that combine treatments for AUD and AH
• Promote collaboration between hepatology and addiction specialists
• Provide evidence about potential risks of drug-induced hepatotoxicity of medications for AUD in patients with AH

Justification/Outcome

Given the value of AlcHepNet resources and the maturation of the program, NIAAA proposes a concept that builds on the previous program successes and also responds to the needs of the hepatology field.  

The structure of the program will be tailored to the evolving knowledge and opportunities to advance NIAAA priorities and scientific community at large.

Several outcomes are expected, including conducting novel clinical trials that will overcome limitations of past, traditional, trial designs as well as providing critical progress in defining new and effective clinical management strategies for patients with severe AH.

Presented by Kendall Bryant, Ph.D., Joe Wang, Ph.D., Division of Metabolism and Health Effects

Mechanism: RFA: R01, R21, R34

Purpose

The purpose of this research initiative is to encourage mechanistic studies that explore alcohol’s effects on the gut-liver-brain interactions and their pathological consequences among HIV/AIDS patients that can be translated into interventions (e.g., pharmacological and behavioral).

The primary focus of the proposed projects should be on the pathophysiological and molecular mechanisms involved in dysregulated interactions between the gut, liver, and/or brain induced by alcohol that could mutually disturb their respective functions, leading to tissue injury among PLWH. It is anticipated that this NOFO will encourage interdisciplinary and collaborative research and new approaches to gain insights into the complex mechanisms of organ pathology and preventive strategies for Alcohol and HIV induced pathology.

Background

The NIH Plan for HIV/AIDS Research FY2020-2025 has identified the importance of basic behavioral and biological research that can be translated into interventions. This high-priority area has been identified as the Cross-Cutting initiative. Basic research provides the underpinning for HIV science in all other prevention and treatment priority areas. It also may identify gaps and emerging areas where additional work can improve our understanding of how HIV is transmitted and persists (e.g. in viral reservoirs) in the context of alcohol use that has a direct impact on translation (e.g. therapeutics and vaccines).

Statement of Work or Scope of Research Projects

The future NOFO will solicit alcohol-focused biological research projects that examine pathophysiological alterations in the gut-liver-brain axis in the  development of liver/organ disease and cognitive impairment in people living with HIV/AIDS (PLWH) with multiple patterns of alcohol drinking. The NOFO will also support applications that deal with determination of relevant biomarkers for diagnosis and therapeutic targets for prevention/treatment of HIV/alcohol-associated liver/organ disease and pathogenic sequelae resulting in increased frailty and mortality. Studies considered responsive to the NOFO must:

• utilize systems biology approach;
• integrate data from functional metagenomics, metabolomics, gut barrier dysfunction, and immunological alterations.

Outcome and Justification

Research under this initiative is directly relevant to Cross-Cutting research initiatives outlined in the NIH Plan for HIV/AIDS Research FY2020-2025. This research should obtain translatable insights from specific dynamic aspects of gut microbial dysbiosis and accompanying metabolomic and inflammatory changes. These changes may contribute to liver disease and other organ injury in PLWH  and assess ancillary impact on brain function and cognitive impairment by:

• collecting data from cross-sectional and longitudinal cohorts, and investigating the relationship among functional metagenomics of the gut microbiome, metabolomics, gut barrier dysfunction, and systemic and mucosal immunological alterations and markers of liver/organ disease and injury and for brain and cognitive functioning in HIV;
• determining the effects of gut microbial dysbiosis on fecal and serum metabolites, intestinal barrier dysfunction, mucosal immune dysfunction and HIV latency, gut and systemic inflammatory changes, and/or
• developing and testing intervention strategies and approaches, including repurposing FDA approved medications, in proof-of-principle models that could mitigate some of intermediate outcome measures including metabolic and inflammatory conditions associated with HIV/alcohol pathology (including further understand the role of existing alcohol-related pharmacotherapies on HIV outcomes).

Research Scope not responsive to NOFO

Research which is not interdisciplinary and directly relevant to Cross-Cutting priorities outlined under the NIH Plan for HIV/AIDS Research for FY2020-2025 is  unresponsive.

Presented by Laura Kwako, Ph.D., NIAAA and Albert Avila, Ph.D., National Institute on Drug Abuse

161st Meeting of the National Advisory Council on Alcohol Abuse and Alcoholism (NCAA), 

September 8, 2022 (October 2022 Council)

Re-issue of PAR 19 207

Participating ICs: NIAAA, NIDA

Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIAAA/NIDA R25 program is to support educational activities that foster a better understanding of biomedical, behavioral, and clinical research on alcohol and other substance use disorders and their implications.

Scope of the Education Program

To accomplish the stated over-arching goal, this NOFO will support creative educational activities with a primary focus on Outreach. Specifically, this NOFO will support projects designed to engage practicing health care professionals in education about current and emerging knowledge derived from scientific research on biomedicine, neurobiology, epidemiology, prevention, and/or treatment of alcohol use disorders (AUD, specific to NIAAA) or substance use disorders (SUD, including AUD – specific to NIDA) and related health conditions.

Eligible Participants

For the purpose of this NOFO, “health care professional” is broadly defined to include a variety of licensed/credentialed health care providers, therapists, and allied professionals who provide direct patient care in general or specialty practice settings. Examples include but are not limited to physicians and nurses in primary care, general medical settings, emergency departments and trauma centers; medical staff in hepatology practices; nurses, social workers, and therapists in public health clinics, schools, child welfare, and criminal justice settings; pharmacists; medical staff in infectious disease clinics; and health professionals in other settings in which patients with alcohol or other substance use issues are likely to seek and receive services (including services unrelated to substance use).

Outcome/Justification

There is a need to continue this program, considering the intractable public health impact of alcohol, opioids, and other substances, their associated consequences, and the persistent stigma associated with them. It is imperative that health professionals possess the latest knowledge about addiction and strategies for addressing it during interactions with a patient, including the neurobiological basis of addiction; evidence-based screening and assessment tools; preventive interventions; how and when to effectively deliver brief motivational interventions; behavioral therapies; available medications for the treatment of alcohol use disorder, opioid dependence, and opioid withdrawal; the role of prescription drug monitoring programs; regulations governing the use and sharing of medical records and patient information (Common Rule, HIPAA, 42 CFR Part 2); service needs of subgroups and special populations; addressing common co-occurring disorders; and strategies for referring patients to specialty treatment services.

NIDA-Specific Language

NIDA will support applications to the re-issue of  PAR 19 207 for projects designed to engage practicing health care professionals in education and research on substance use disorders. This can be accomplished using a variety of approaches, models, and activities. Competitive programs should provide high impact research experiences to health care providers, those training to be health care providers, or those training health care providers. Activities should go beyond the development of brochures or toolkits, unless there is substantial clear evidence for the impact of such materials, and they are measurably different from what already exists. Applications that address health disparities, underrepresented populations, or underserved and disadvantaged populations are encouraged. Furthermore, NIDA is looking for creative and novel approaches to training health care providers in substance use disorders. Each program should address the following components within the application:

• A comprehensive dissemination plan describing how the materials developed can be shared with other potential programs and partners.
• An evaluation plan that canvasses participants and mentors. The evaluation plan should include detail how feedback will be gathered, interpreted, and implemented throughout the life of the program.
• Evidence that the program can continue beyond the life of the grant is essential.

Presented by Robert Freeman, Ph.D., Division of Epidemiology and Prevention Research

May 10, 2022

Purpose

In light of the documented increases in both alcohol misuse (among some individuals) and domestic violence (DV) as a result of the global COVID-19 pandemic and array of mandated restrictions enacted to mitigate COVID spread, the purpose of this grant application solicitation is to announce NIAAA’s interest in addressing  alcohol and DV. A critical need for research includes development of testing and interventions proximal to drinking occasions when risk of DV is elevated. The results would be hypothesized to include interventions sufficient  to decrease the likelihood of alcohol consumption at levels sufficient to trigger DV and to provide skills that would reduce the risk of DV perpetration and victimization.

Background

Several decades of methodologically rigorous research has demonstrated that alcohol use is an important contributing factor in many instances of DV/IPV. Unfortunately, evidence for the effectiveness of preventive interventions for IPV is underwhelming. Development of effective interventions—e.g., traditional batterer intervention programs—has been limited by high dropout rates, treatment resistance, and poor working alliance, while the United States Preventive Services Task Force has found only limited evidence for the efficacy of IPV screening instruments for men.

The NIAAA’s release of this solicitation at this time reflects a number of recent developments. Clearly, the evidence of increased rates of heavy drinking and DV during the COVID-19 pandemic lockdown period signals an urgent need for efficacious interventions that can reduce alcohol-involved DV. Moreover, the global pandemic, in general, has highlighted the utility of mHealth approaches for reaching DV survivors who may remain dangerously sequestered with an abusive partner while likely enduring adverse physical, psychological, social, and economic conditions.  Indeed, remote intervention delivery possesses a number of attractive features, including enhanced reproducibility; greater engagement (i.e., can be made available 24/7); enhanced reach (increased treatment options for those who live in, e.g., rural areas); greater privacy and lower cost. Importantly, too, wireless and remotely delivered interventions—which have shown efficacy in changing various health behaviors—can be delivered in real time, at the critical moment of greatest need. Growing evidence suggests that many DV survivors prefer the practicality and confidentiality of technology-enabled interventions and guided online support to in-person face-to-face services such as group counseling and individual therapy.

Research Scope

NIAAA encourages the submission of applications that include, but are not limited to, the following areas:

• basic behavioral and etiological research, including experimental research, that informs and test theoretical models of the association between individual and contextual factors, drinking patterns, and IPV/DV perpetration daily and over time
• studies that advance ecological momentary assessment (EMA) research methodology that assesses individuals in their own environment in near real-time, providing insights in understanding in-the-moment Establishing the feasibility of EMA techniques to capture proximal moderators of the alcohol-IPV relationship (e.g., negative affect, emotion dysregulation) figures to enhance understanding of IPV/DV episodes and provide crucial information for the development of preventive interventions. The contextual and situational factors surrounding DV/IPV episodes (e.g., where and with whom one is drinking; motives for use; feelings of craving, stress) can be probed using EMA methods and illuminated by continuously collected data from mobile phone sensors indicating date, time and movement (suggestive of change in activities; etc) that may signal initiation of alcohol use.
• studies to assess the feasibility, acceptability, and efficacy of Just-In-Time interventions for alcohol-related IPV/DV that can be deployed before or during the drinking episode with the aim of reducing the amount consumed and/or preventing adverse consequences.
• research that advances dissemination and implementation of preventive interventions for alcohol-related DV. Such research can provide an important next step in moving promising preventive interventions out into the field. Current interventions for IPV tend to be resource intensive. The NIAAA encourages the development of scalable, sustainable interventions that can be readily integrated into community practice; delivered using existing service platforms, personnel, and resources; and that incorporate features that ease implementation fidelity. For instance, an effective online platform eventually might be incorporated into primary care or women’s wellness clinics, urgent care facilities, community or school-based health clinics, mobile clinics, HIV clinics, VA facilities, and substance use treatment providers to provide access to information, motivation building, and skills training to reduce risk for violence victimization.
• studies that advance basic behavioral and intervention development research with populations that are at elevated risk for alcohol-related IPV/DV but which remain relatively understudied (e.g., sexual/gender minority students; community college students; military populations).

Outcome

This solicitation seeks to advance the development, feasibility, acceptability, pilot testing, potential efficacy, and implementation of scalable, low resource, and remotely delivered interventions via mobile devices that rely on communication technologies for reducing and preventing alcohol-triggered DV.

Presented by Kendall Bryant, Ph.D.

February 10, 2022

Background

The U.S. Department of Health and Human Services (HHS) launched the Ending the HIV Epidemic in the U.S. (EHE) initiative in 2019. The initiative aims to reduce new HIV infections in the U.S. by 90% by 2030 by scaling up key HIV prevention and treatment strategies. This ambitious goal to end the HIV epidemic in the United States by 2030 is through the application of nearly four decades of investments in scientific research that have yielded prevention and treatment breakthroughs that now make it possible to control HIV infection.  However, the role of alcohol use, and alcohol-related mental health and other substance use problems as well as environmental consequences of alcohol exposure (e.g., homelessness) exist at an individual, group, and societal level. These complex alcohol-related interconnected problems in living continue to impede this ambitious goal to End the Epidemic. Improved alcohol-focused assessment, a further understanding of impaired decision making, distribution of alcohol-related services and the implementation of effective HIV and alcohol-focused interventions at multiple levels can facilitate the achievement of EHE goals to substantially reduce new HIV infections.

The EHE initiative is also working to address racial, ethnic, and geographic disparities that have contributed to HIV prevention gaps. Many HIV and alcohol-related health disparities are part of the U.S. population and may impair the HIV Ending The Epidemic. Reducing alcohol use disorders and/or patterns of heavy drinking (AUD) is one of the most important of these interventions, influencing HIV transmission, HIV progression, HIV medication adherence, and non-HIV mortality. Conditions that often co-occur with AUD in particular, tobacco use, unhealthy substance use, and psychiatric disorders are alcohol-related HIV risk factors which form intra- and inter- personal clusters of risk. These clusters are increasingly understood to be mutually reinforcing and mutually interactive attributes of dysregulations in brain’s emotional circuitry that are exacerbated by social stressors, working in concert with environmental factors to increase HIV risk and difficulty of the application of simple interventions.

At the same time as commonalities in psychosocial-behavioral pathways are being appreciated, information on relevant social and contextual factors for these pathways is increasingly collected by health systems and through other data streams. The new widespread availability of this information may offer an opportunity to identify and address entrenched HIV-related disparities from a new vantage point that call for more comprehensive analytic approaches. In particular, individuals with a multitude of social stressors, common in disparity-impacted groups, are likely to have AUD and other alcohol-related manifestations. Anticipated coordinated efforts across government agencies promises to provide additional expertise, technology, and resources where they are needed most to integrate a comprehensive approach to HIV health.

In general, this initiative calls for the implementation of HIV and Alcohol -related intervention strategies to:

Provide an early diagnosis for all individuals with HIV and an identification of an amelioration of alcohol misuse and associated mental health and substance use disorders that impacts the prevention of HIV transmission in vulnerable populations.

Treat HIV infection rapidly and effectively to achieve sustained viral suppression in the context of alcohol’s impact on adherence to life-long medication regimens and reduce pathophysiological impact of continuing alcohol misuse.

Protect at-risk individuals who drink and are in “wet” environments (high density of alcohol outlets  that reinforce social norms that sustain unhealthy drinking) from acquiring HIV infection using proven HIV and Alcohol interventions, including pre-exposure prophylaxis (PrEP).

Rapidly detect and act on emerging HIV and alcohol clusters and prevent new infections within social networks of alcohol and alcohol-related disorders including depression, anxiety, pain, trauma, other substance use and medications that place individuals at greater risk for adverse outcomes.

Research objectives are focused in several primary areas of interest in which to address EHE goals including but not limited to:

Alcohol-Related Behavioral Research (ARBR) and its Integration into Primary and Secondary HIV Prevention Interventions

This  research initiative is designed to be responsive to the NIH FY2021-2025 Strategic Plan for HIV/AIDS. Research in the high priority areas of Reducing the Incidence and Cross-Cutting Research, that relates alcohol misuse, and patterns of  alcohol consumption to ending the HIV epidemic in the US and beyond. This cross-cutting initiative, focusing on dynamic behavioral research, was generated in response to the importance of ARBR whose ultimate goal is to facilitate HIV prevention efforts and therefore to increase awareness of its current scope and implications for HIV prevention and treatment. These targeted areas include:

• Increased understanding of community settings where HIV prevention and treatment occurs, sheds light on behavioral and cultural practices within key populations and networks that influence HIV transmission and prevention and facilitates awareness of how behaviors are shaped by environmental, social, and structural factors.
• Increased widespread adoption of new technologies such as smartphones, mobile apps, social media, and text messaging as components of Elemental BSSR offering new opportunities for monitoring HIV-related behaviors and for delivering tailored in-the-moment interventions.
• Expanded multidimensional HIV and Alcohol risk assessment and messaging interventions for rapid implementation by incorporation of comprehensive alcohol assessment and behavioral/polypharmacy risk messages into a series of  behavioral interventions for PLWH.
• Increased patient and practitioner readiness to report willingness to change unhealthy alcohol and polypharmacy use after receiving personalized risk messages that incorporate their direct alcohol measurement (Phosphatidyl ethanol or PEth) value, other alcohol monitoring technology, and genetic/familial liability.
• Assessment of additional environmental factors that increase risk for adverse outcomes and contribute to risk through social/behavioral and/or epigenetic phenomena (Envirome) to rapidly identify priority populations and geospatial locations where HIV is spreading and provide data-driven evidence-based guidance for public health decision-making to support the goals of the Ending the HIV Epidemic:

Targeted Resources

The initiative will target resources to the 48 highest burden counties, Washington D.C., San Juan, PR, and 7 states with substantial rural HIV burden.
Source: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

EHE’s comprehensive approach focuses resources where they are needed most and strives to meet people where they are with the services they need. The initiative provides a targeted infusion of new resources and support to 50 local areas that account for more than half of new HIV diagnoses (48 counties; San Juan, Puerto Rico; and Washington, D.C.), and seven states with a substantial rural burden. Through increased investments and local innovation, EHE aims to make history — and end the domestic HIV epidemic once and for all.

Applications that propose the following will be considered non-responsive and will not be reviewed:

• Research that does not focus on one of the geographically defined priority areas
• Projects that develop de novohealth interventions with a primary aim of testing efficacy
• Research that does not involve one or more collaborations with local implementing partners
• Animal studies, drug discovery or device safety trials with registrational requirements
• Studies that do not include a multidisciplinary team approach