Division of Therapeutics and Medical Consequences | NIDA

Mission of DTMC

To use science as a vehicle for improving the treatment of Substance Use Disorders (SUDs) and their medical consequences, focusing on the identification, evaluation, and development of safe and effective therapeutics, such as medications, biologics. devices, digital, and behavioral interventions.

The DTMC achieves this mission by:

Supporting and conducting research on innovative pharmacological and non-pharmacological approaches for treating SUDs and facilitating recovery.
Collaborating with pharmaceutical companies and other federal agencies involved in therapeutic development.
Facilitating the regulatory approval process for new medications, devices, and digital therapeutics for SUDs.
Promoting the development of reliable methods to measure the safety and efficacy of SUD treatments in preclinical models and clinical trials.
Investigating the medical consequences of SUDs, including infections such as HIV and Hepatitis C, and developing treatments for SUDs comorbid with other health conditions.
Disseminating the knowledge gained from DTMC-supported research to improve the treatment outcomes of patients with SUDs.

DTMC Pipelines of Therapeutics

Opioid Use Disorder and Overdose

Early Preclinical	Late Preclinical	Phase I Clinical Trials	Phase II Clinical Trials	Phase III Clinical Trials	New Formulation
NTR1 modulator 5-HT2A/2C Agonist HBS087/HBS093 D-CYSee SBI-0801315/SBI-0799220 KOR Modulator MOR selective antagonist NAM368 Fentanyl/heroin vaccine	Oxytocin Methocinnamox MOR modulator GM-3009 (Oxa-iboga analog) SBS-226 DMX-101 EPD-2520 M-KLH (Heroin Vaccine) Fentanyl vaccine Fentanyl mAb	Oxytocin Cannabidiol VK4-116 AZD4041 VVZ-2417 KNX100 AT-121 EC5026 SBS-147 TRN-228 Kindolor MEB-1170 NRS-033 MG001 (Mitragynine) Oxycodone vaccine Morphine/Heroin vaccine	Cannabidiol Suvorexant Ketamine Semaglutid Semaglutid Psilocybin Dronabinol/Cannabidiol CS-1103 Buprenorphine + Naltrexone Buprenorphine Buprenorphin Buprenorphine (LDI) CSX-1004 (Fentanyl mAb)	Suvorexant	Naltrexone 2-month injection BICX104 (Naltrexone 3-month implant) OLANI (Naltrexone 6-month implant) BIOPIN 6 (Naltrexone 6-month implant) Novel Naltrexone transdermal patch (NNTP) Nalmefene implant PF614-MPAR (Nafamostat/Oxycodone ADF) Buprenorphine ≥3-month injection Buprenorphine 6-month implant

If you have questions, please contact Ivan Montoya or Marta de Santis.

Stimulant Use Disorder and Overdose

Early Preclinical	Late Preclinical	Clinical Trials
Early Preclinical	Late Preclinical	Phase I	Phase II	Phase III
SBI-0801315/SBI-0799220 SBS-518	OMS 182399 PPL-138 NHB 1109 CocH5-Fc(M6)	CS-1103 Exenatide BICX104/Bupropion STP-7-Mavoglurant Troriluzole Pentoxifylline Psilocybin Semaglutide	Semaglutide Bupropion/Naltrexone

If you have questions, please contact Katrina Foster or Ivan Montoya or Marta de Santis.

Tobacco Use Disorder

Early Preclinical	Late Preclinical	Clinical Trials
Early Preclinical	Late Preclinical	Phase I	Phase II	Phase III
	ATI-1013 (anti-nicotine monoclonal antibody)	AT-1082 (ɑ3Ɓ4 partial agonist) Tetrahydrocannabivarin mGlu2 PAM SBP-9330	Exenatide + NRT Tirzepatide+NRT

If you have questions, please contact Karen Seymour or Julia Donnelly.

Cannabis Use Disorder

Early Preclinical	Late Preclinical	Clinical Trials
Early Preclinical	Late Preclinical	Phase I	Phase II	Phase III
		Selonabant	Cannabidiol/Hemp-derived cannabinoids

If you have questions, please contact Jia Bei Wang or Julia Donnelly.

Therapeutic Devices Pipeline

Preclinical	Feasibility /Target Engagement/Early Efficacy	Efficacy	Pivotal
Closed-loop System for Opioid Induced Respiratory Depression Phrenic Nerve Stimulator for Opioid Overdose Implantable Naloxone Delivery System Point of Care Diagnosis (DoseCheck)	Transcranial Magnetic Stimulation for Cocaine Use Disorder Transcranial Magnetic Stimulation for Cocaine Use Disorder Deep Transcranial Magnetic Stimulation for Stimulant Use Disorder Telehealth Transcranial Magnetic Stimulation for Nicotine Use Disorder with Cancer Transcranial Magnetic Stimulation for Nicotine Use Disorder Transcranial Direct Current Stimulation + cognitive training for opioid use disorder Transcranial Direct Current Stimulation with reappraisal for Cannabis Use Disorder Telehealth Transcranial Magnetic Stimulation for Cannabis Use Disorder Low-Intensity Focused Ultrasound for Cocaine Use Disorder Low-Intensity Focused Ultrasound for Cocaine Use Disorder Low-Intensity Focused Ultrasound for Opioid Use Disorder Heart Rate Variability Biofeedback for Substance Use Disorder	Repetitive Transcranial Magnetic Stimulation for smoking cessation in Schizophrenia Transcranial Direct Current Stimulation for Opioid Relapse Low-Intensity Focused Ultrasound for Opioid Use Disorder NSS-2 Bridge Device following surgery Sparrow Ascent System in PTSD and Opioid Use Disorder	Vagus Nerve Stimulation for Opioid Use Disorder Transcranial Magnetic Stimulation for Nicotine Use Disorder

If you have questions, please contact Carmela Reichel or Jennifer Wong

Behavioral Therapies Pipeline

Stage I	Stage II	Stage III
Virtual Reality-Augmented Future Orientation in Stimulant Use Disorder Recovery Testing the feasibility and acceptability of social media and digital therapeutics to decrease vaping behaviors Computerized Distress Tolerance Intervention for Cannabis Use Disorder Adaptive Psychological Intervention to Improve Pain and Reduce Opioid Use after Injury	Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation Contingency Management with Deep Transcranial Magnetic Stimulation for the Treatment of Cocaine Use Disorder Efficacy and Mechanisms of Web-Based Regulation of Craving Training for Smoking Cessation	Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings Integrated Treatment for Veterans with Co-Occurring Chronic Pain and Opioid Use Disorder Use of blinded tapering for hypnotic discontinuation

If you have questions, please contact Will Aklin or Jennifer Wong

Digital Therapeutics Pipeline

Early Feasibility	Feasibility	Pivotal
Vaper to Vaper (V2V): A Multimodal Mobile Peer Driven Intervention to Support Adolescents in Quitting Vaping Re-Connect: Personalized, Non-Monetary Smartphone-based Rewards for Smoking Cessation Testing the feasibility and acceptability of social media and digital therapeutics to decrease vaping behaviors Development of an mHealth Behavioral Sleep Medicine Intervention for use during Medication Assisted Treatment for Opioid Use Disorder Autonomous Digital CBT Intervention for OUD with Co-Occurring Internalizing	ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation Continuing Care App for Justice-Involved Individuals with Substance Use Disorders A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: Digital RITch®CBT vs. Standard CBT The Vira Platform: A Contextually Triggered Just-in-Time Adaptive Intervention for Opioid Use Disorder	Randomized Controlled Trial of a Novel Smoking Cessation Application Tailored to Individuals with Serious Mental Illness Enhancing Hypnotic Medication Discontinuation in Primary Care through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy Actify! An mHealth mood management tool to improve population-level smoking cessation

If you have questions, please contact Will Aklin or Jennifer Wong

Medical Consequences Grants Portfolio

Respiratory	Cardiovascular	Hepatitis and Other	HIV
Opioid-induced respiratory depression Bronchial epithelium and marijuana Menthol cigarettes and toxins Behavioral changes for overweight smokers E-cigarettes on the human lung	Cardiovascular effects of polydrug Heart rate variability in SUD Cardiovascular effects of cocaine reduction Cannabis and cardiovascular outcomes PET MRI for atherosclerosis and cocaine	Hepatitis-C in IDU Hepatitis-C in CJ Patient oriented research in Hepatitis C Linkage of care for Hepatitis C in criminal justice system Cannabis and reproduction	Opioids and HIV IDU, HIV, HCV - liver fibrosis Opioid-neuro HIV comorbidity Neuro-Aids and opioids Acute HIV point-of-care diagnosis HIV Cocaine Bone Marrow Blood Barrier Gene drive therapy in IDU Heart and cannabis in HIV Smoking cessation HIV/TB in South Africa Behavioral intervention for viral suppression Chronic pain in HIV and DA	HIV and other infectious consequences Behavioral interventions in Hispanics with HIV Cannabis in pain and inflammation in HIV M-health technology in HIV and DA HIV-patient-oriented research Substance use training research in HIV Clinical investigator training in HIV and SU Interferon-modulated vaccines against HIV Health consequences of polydrug use in HIV

If you have questions, please contact Raul Mandler, MD, or Julia Donnelly.

Research Programs

Division Listings

Office of the DTMC Director (OD)
Chemistry and Pharmaceutics Branch (CPB)
Clinical/Medical Branch (CMB)
Clinical Research Grants Branch (CRGB)
Medications Discovery and Toxicology Branch (MDTB)
Regulatory Affairs Branch (RAB)

Mailing Address

Division of Therapeutics & Medical Consequences
National Institute on Drug Abuse
C/O NIH Mail Center
3WFN MSC 6016
16071 Industrial Drive – Dock 11
Gaithersburg, MD 20892*
*(Use 20892 for U.S. Postal Service, 20877 for UPS and FedEx)

(301) 443-6173 (phone)
(301) 443-2599 (fax)