Division of Treatment and Recovery | NIAAA

The Medications Development Branch (MDB) plans, stimulates, develops, and supports pharmacotherapy research to AUD. This includes advancing promising medications through the drug development pipeline: identifying lead compounds and optimizing their structure for potency, stability, selectivity/specificity, bioavailability, testing for preclinical efficacy (e.g., alcohol animal models), completing IND requirements (pharmacokinetic evaluations, toxicology, and formulation/manufacturing), supporting phase 1 studies (pharmacokinetic evaluations, pharmacodynamics/target engagement, safety, alcohol interaction, and abuse liability), conducting human laboratory studies and clinical trials, and directing secondary analyses to improve methodology of pharmacotherapy clinical trials for the treatment of AUD. MDB is also committed to research precision medicine to predict favorable responders (both efficacy and safety) to a specific medication, alcohol/psychiatric comorbidity, especially post-traumatic stress disorder, internal and external collaborations to advance the development of medications for AUD, and training programs to assure that adequate numbers of highly competent scientists are engaged in current and future research on medications development.

High priority MDB activities include:

• Developing and testing novel and repurposed medications for the treatment of AUD
• Advancing precision medicine by identifying  subgroups who respond favorably to experimental compounds. This includes developing novel computational analytical approaches using a combination of patient characteristics and biomarkers; discovering new biomarkers is a high priority that includes the integration of “multi-omics” signature profiles involving expression of genes, RNA, proteins, and metabolites; brain endogenous metabolites, electrophysiological variation, individual cell imaging and other biological mechanisms such as hiPSC-based neuronal models
• Developing new pharmacological treatments to treat patients with AUD and psychiatric comorbidity (e.g., post-traumatic stress disorder)
• Stimulating research that develops and evaluates alcohol biosensors for the purpose of objectively measuring real-time alcohol intake
• Developing and implementing a standardized human laboratory paradigms program for screening/testing promising medications
• Promoting the initial evaluation of promising new compounds in human patients via the NIAAA SBIR Investigational New Drug (IND)-enabling program

The Treatment, Health Services, and Recovery Branch (THSRB) stimulates and supports research in broad categories such as health services, behavioral therapies and mechanisms of behavioral change, recovery, translational research, and innovative methods and technologies for AUD treatment and sustaining recovery. Other areas of interest include topics focusing on special-emphasis and underserved populations, including HIH-designated US health disparity populations, as well as those with co-occurring disorders, and fetal alcohol spectrum disorders (FASD). In all studies, at all levels from FASD to elderly, efforts are made to include participants that reflect the diversity of the population at large.  High priority THSRB activities include:

• Improving health services research: focusing on four main areas: 1) make evidence-based treatment more accessible to patients; 2) make treatment settings more appealing to patients; 3) make treatments more affordable; and 4) disseminate and implement evidence-based behavioral and pharmacological treatments into professional healthcare practices. Other areas include:
  • Improving access to evidence-based treatments by identifying and developing strategies to reduce the barriers (personal and structural) that prevent people with AUD and alcohol misuse from seeking and receiving appropriate care
  • Exploring the treatment gap as it relates to sex, age (from adolescence through older adulthood), race/ethnicity, socio-economic status, immigration status, and health literacy, and improving service delivery systems and innovations to facilitate access to care
  • Removing the stigma of AUD and integrate AUD treatment into mainstream health care
• Improving the effectiveness of behavioral interventions:
  • Evaluating evidence-based behavioral therapies in real world treatment settings
  • Disseminating clinical practice findings from mechanism of behavioral change studies that have shown promise in enhancing the effectiveness of behavioral therapies
  • Using dynamic and person-centered statistical modeling approaches to evaluate how heterogeneity impacts alcohol use behavior within specific AUD treatments
• Understanding the dynamics of post-treatment recovery (see NIAAA’s research definition of recovery):
  • Explore the neurobiological, psychological, environmental, and social factors that influence post-treatment recovery
  • Determine trajectories of recovery in subgroups of people with different cultural and socioeconomic backgrounds, cognitive abilities, and medical histories
  • Identify factors associated with so-called natural recovery and how these factors can be applied to change the behavior of those in treatment
  • Explore continuing care treatments that aim to support long-term recovery   
• Understanding how the social determinants of health (i.e., environmental, social, cultural, and economic factors) influence outcomes and sustainability in health disparities:
  • Removing barriers that keep racial, ethnic, and sex minorities from seeking and receiving appropriate health care
  • Implementing effective treatments that are tailored for these populations in diverse clinical and other settings
  • Determining how social/cultural factors influence treatment accessibility, effectiveness, and long-term recovery
  • Developing measures to assess care delivery models to better address the issues underlying health disparities
• Improving treatments for co-occurring PTSD, anxiety, depression, and AUD:
  • Integrating treatments for co-occurring AUD and mental health conditions to address the heterogeneity that exists among patients
  • Identifying which types of services, service providers, and treatment settings work best for which subgroups
  • Determining how the treatment of one disorder can influence the risks, progression, and outcome for the other disorder
• Harnessing new technology (e.g., mobile, computer, web-based applications, super intelligence/machine learning, geo-locations, and robotics) to increase the accessibility and effectiveness of a variety of treatments:
  • Using new technologies to disseminate evidence-based behavioral treatments among hard-to-reach populations, improve effectiveness of telemedicine, and enhance the continuum of care  
  • Investigating new digital technology ways of capturing real-time data in clinical trials and treatment protocols
• Improving clinical research methods:
  • Developing efficient, adaptive clinical trial designs and statistical analyses that allow treatment adjustments based on the changing disease status of the patient
  • Exploring new statistical models and methods for evaluating treatment effectiveness and recovery
  • Investigating statistical approaches that capture changes in outcomes over time and convey results that are more clinically intuitive.
• Improving alcohol treatment outcomes for women:
  • Comparing effectiveness of standard treatment approaches, such as group counseling and relapse prevention, in single-sex vs. mixed-sex groups   
  • Developing new strategies for alcohol screening, diagnosis, and interventions and tailor them to women in diverse settings, including prenatal care and specialty health care 
  • Understanding the impact of coexisting conditions, including other substance use and mental health disorders, on alcohol-related health care, illness, and death among girls and women  
  • Examining the effects of stress, early childhood trauma, childhood adverse events, and co-occurring disorders on women’s drinking  
• Increasing the number of behaviorally-oriented clinical researchers (primarily clinical psychologists) who receive NIAAA training and career development grants (F’s, K’s—especially, the K99/00).

NIAAA-supported research has led to advancements in medications for alcohol use disorder.

The medications development branch supports a well-developed, integrated program called the NIAAA Alcohol Pharmacotherapy Evaluation Program (APEP) to help encourage the development of medications to treat AUD, and to bridge the gap between preclinical studies and Phase III clinical trials. APEP efficiently advances candidate therapeutic compounds by conducting Phase II, human laboratory, and alcohol interaction clinical trials.

NIAAA DTR has developed a formal conceptual and operational definition of recovery for the alcohol treatment and recovery field.