Division of Therapeutics and Medical Consequences (DTMC)

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

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 5HT2R agonist HBS087/HBS093 PN6041/PN6047 D-CYSee SBI-0801315/SBI-0799220 Opioid biased agonist MOR Selective agonist Oxy/Fentanyl nano-vaccine Fentanyl/heroin vaccine GDNF gene therapy	BTRX-246040 PF5190457 AT-121 TRN-228 NaV1.8 inhibitor CS-1103 Methocinnamox Mitragynine analogs R-methadone prodrug MOR modulator GM-3009 (Oxa-iboga analog) SBS-226 M-KLH (Heroin Vaccine) Fentanyl vaccine mAb Fentanyl	Lofexidine Lofexidine Dextromethorphan /Bupropion  CVL-354 INDV-2000 AZD4041 KNX100 NYX-783 EC5026 SBS-1000 Kindolor Psilocybin MEB-1170 NRS-033 ITI-333 EPD2520 Oxycodone vaccine	Cannabidiol Guanfacine Pregabalin + Lofexidine Suvorexant Pramipexole Olanzapine Ketamine Ketamine Ketamine Semaglutide  Semaglutide  Buprenorphine + Naltrexone Buprenorphine Buprenorphine INDV-2000 CSX-1004 (P1A4 Fentanyl mAb)	Suvorexant	Naltrexone 2-month injection BICX104 Naltrexone 3-month implant OLANI (Naltrexone 6-month implant) DLP-160 (Naltrexone 6-month implant) BIOPIN 6 (Naltrexone 6 month implant) Novel naltrexone transdermal patch (NNTP) LAAM LYN-014 LYN-013 Nalmefene implant Nanoparticle-based ADF PF614 - MPAR (Nafamostat/ Oxycodone ADF) Buprenorphine

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	OMS 182399  PPL-138 IXT-m200 Long –Acting  NHB 1109	Zolmitriptan TMP-301 Cocaine hydrolase gene therapy dAdGNE h2E2 CS-1103 SXC-2023-Glutamate Modulator	Cariprazine Mirtazapine Clavulanic acid  Ketamine Exenatide BICX104/Bupropion STP-7-Mavoglurant	Pioglitazone Rotigotine Bupropion/Naltrexone EMB-001 TNX-1300

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

Tobacco Use Disorder

Tobacco Use Disorder

Early Preclinical	Late Preclinical	Clinical Trials
		Phase I	Phase Ib	Phase II	Phase III
	ATI-1013 (anti-nicotine monoclonal antibody)	AT-1082 (ɑ3Ɓ4 partial agonist)	SBI-0069330 (mGlu2 PAM)	Suvorexant Isradipine Ketamine Varenicline + Guanfacine Exenatide + NRT (in overweight/prediabetic smokers) Psilocybin Varenicline (in adolescent e-cigarette users)

If you have questions, please contact Evan Herrmann or Julia Donnelly

Cannabis Use Disorder

Cannabis Use Disorder

Early Preclinical	Late Preclinical	Clinical Trials
		Phase I	Phase II	Phase III
CB1 antagonist for Acute Intoxication		Selonabant Acute Cannabis intoxication	Varenicline PF-04457845 Cannabidiol/ Full spectrum hemp AEF0117

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

Therapeutic Devices Pipeline

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  Transcranial Magnetic Stimulation for Nicotine Use Disorder  Transcranial Magnetic Stimulation for Nicotine Use Disorder  Transcranial Magnetic Stimulation for Nicotine Use Disorder  Transcranial Direct Current 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  Deep Brain Stimulation for Methamphetamine Use Disorder  Heart Rate Variability Biofeedback for Substance Use Disorder Heart Rate Variability Biofeedback for Nicotine Use Disorder	Transcranial Magnetic Stimulation for Nicotine Use Disorder  Transcranial Direct Current Stimulation for Opioid Relapse  Portable tDCS device for Cocaine Use Disorder Low-Intensity Focused Ultrasound for Opioid Use Disorder  NSS-2 Bridge Device following surgery  Vagus Nerve Stimulation for Lower Back Pain  Sparrow Ascent System in PTSD and Opioid Use Disorder	Transcranial Magnetic Stimulation for Nicotine Use Disorder  Vagus Nerve Stimulation for Opioid Use Disorder  Bridge Device for Opioid Use Disorder

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

Behavioral Therapies Pipeline

Behavioral Therapies Pipeline

Stage I	Stage II	Stage III
Virtual Reality-Augmented Future Orientation in Stimulant Use Disorder Recovery An mHealth mood management tool to improve population-level tobacco cessation Mindfulness-Based Addiction Treatment Delivered Through Mobile Technology for Low-Income Smokers Testing the feasibility and acceptability of social media and digital therapeutics to decrease vaping behaviors Computerized Distress Tolerance Intervention for Cannabis Use Disorder Pilot Study to Evaluate a Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers	Brief Individual and Parent Interventions for Marijuana Misuse in Truant Adolescents Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation	Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings Use of blinded tapering for hypnotic discontinuation Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes Randomized trial of telephonic pain self-management to promote opioid tapering Repeated-dose behavioral intervention to reduce opioid overdose: a two-site randomized-controlled efficacy trial Targeting Hedonic Dysregulation to Address Chronic Pain and Opioid Misuse in Primary Care. Integrated Treatment for Veterans with Co-Occurring Chronic Pain and Opioid Use Disorder

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

Digital Therapeutics Pipeline

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	A game-based intervention for Opioid Use Disorder Reducing Non-Medical Opioid Use: An automatically adaptive mHealth Intervention Development and Testing of a Depression-Specific Behavioral Activation Mobile App Paired with Nicotine Replacement Therapy Sampling for Smoking Cessation Treatment Via Primary Care 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	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

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

Medical Consequences Grants Portfolio

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:

• Medications 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

• Related Funding Opportunities

Staff Listings:

• 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)