What We Do:
- Plans and directs studies necessary to identify, evaluate, develop, and obtain FDA approval for new medications and devices to treat Substance Use Disorders (SUD) and related medical and psychiatric conditions;
- Develops and administers a program on basic and clinical research to (a) develop innovative pharmacological and non-pharmacological approaches for SUDs and related medical and psychiatric conditions and (b) investigate the medical consequences of drug abuse, including HIV/AIDS;
- Supports research to identify valid and reliable outcome measures for clinical trials of therapeutics for SUDs;
- Supports training in the pre-clinical and clinical research of therapeutics for SUDs;
- Collaborates with: (a) the pharmaceutical sector in both the United States and abroad, and (b) other federal therapeutic development programs;
- Works closely with FDA in assuring that research designed to demonstrate the clinical efficacy of new compounds is evaluated and approved in an expeditious manner; and
- Disseminates the knowledge acquired by the DTMC funded research.
DTMC Pipelines of Therapeutics
- Opioid Use Disorder and Overdose
Opioid Use Disorder and Overdose Early Preclinical Late Preclinical Phase I Clinical Trials Phase II Clinical Trials New Formulation - Naltrexone 2-month injection
- BICX104 Naltrexone 3-month implant
- Naltrexone 6-month implant
- Naltrexone 6-month implant
- Naltrexone 1-year implant
- Naltrexone transdermal patch
- Nalmefene implant
- LAAM
- LYN-013
- LYN-014
- Buprenorphine (long acting biodegradable)
- Nanoparticle-based ADF
- Nafamostat/PF614 –Oxycodone
- Naloxone (Close loop)
- Pocket Naloxone
- Naloxone (Automated portable system)
If you have questions, please contact Ivan Montoya or Marta de Santis
- Stimulant Use Disorder and Overdose
Stimulant Use Disorder and Overdose Early Preclinical Late Preclinical Clinical Trials Phase I Phase Ib Phase II Phase III - SBI-0801315/SBI-0799220
- CocH5-Fc(M6) Cocaine Hydrolase
- SBX-518
- Pioglitazone
- Rotigotine
- Bupropion/Naltrexone
- EMB-001
- TNX-1300
- IXT-m200 (OD)
- IXT-m200 (MUD)
If you have questions, please contact Katrina Foster or Ivan Montoya
- Tobacco Use Disorder
Tobacco Use Disorder Early Preclinical Late Preclinical Clinical Trials Phase I Phase Ib Phase II Phase III If you have questions, please contact Evan Herrmann.
- Cannabis Use Disorder
Cannabis Use Disorder Early Preclinical Late Preclinical Clinical Trials Phase I Phase II Phase III If you have questions, please contact Aidan Hampson.
- Therapeutic Devices Pipeline
If you have questions, please contact Will Aklin or Jennifer Wong
- Behavioral Therapies Pipeline
If you have questions, please contact Will Aklin
- Digital Therapeutics Pipeline
If you have questions, please contact Will Aklin
- Medical Consequences Grants Portfolio
If you have questions, please contact Will Aklin
Research Programs:
- Pharmacotherapies Development Program
- The Addiction Treatment Discovery Program (ATDP)
- Regulatory Affairs Program
- Behavioral Therapy Development Program
- Device Development for Substance Use Disorders
- Digital Therapeutics Development Program
- Clinical Trial Outcomes Development Program
- NIDA Drug Supply Program
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)
Funding Opportunities
Staff Listings:
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)