Division of Therapeutics and Medical Consequences (DTMC)

What We Do:

1. 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;
2. 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;
3. Supports research to identify valid and reliable outcome measures for clinical trials of therapeutics for SUDs;
4. Supports training in the pre-clinical and clinical research of therapeutics for SUDs;
5. Collaborates with: (a) the pharmaceutical sector in both the United States and abroad, and (b) other federal therapeutic development programs;
6. 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
7. 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
GPR151 antagonist NHB 1109 (PTPRD inhibitor) 5HT2R agonist HBS087/HBS093 PN6041/PN6047 D-CYSee SBI-0801315/SBI-0799220 Opioid biased agonist MOR Selective Antagonist Oxy/Fentanyl nano-vaccine Fentanyl/heroin vaccine GDNF gene therapy	Brexpiprazole BTRX-246040 PF5190457 AT-121 TRN-228 (Cebranopadol) Kindolor ST-18444 CS-1103 VK4-116 Methocinnamox Mitragynine analogs R-methadone prodrug NAY Heroin vaccine M-KLH (Heroin Vaccine) Fentanyl vaccine mAb Fentanyl	Cannabidiol Cannabidiol Cannabidiol Lemborexant Liraglutide/Semaglutide Lofexidine Dexmedetomidine CVL-354 INDV-2000 (formerly C4X3256) AZD4041 KNX100 NYX-783 EC5026 SBS-1000 (formerly MP1000) MEB-1170 NRS-033 ITI-333 EPD-2520 (formerly RM2520 and PZM21) CSX-1004 (Fentanyl mAb) Oxycodone vaccine	Cannabidiol Guanfacine Pregabalin + Lofexidine Suvorexant Pramipexole Olanzapine Ketamine Buprenorphine + XR Naltrexone	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	OMS 182399  PPL-138 IXT-m200 Long –Acting  NHB 1109	Zolmitriptan TMP-301 Cocaine hydrolase gene therapy dAdGNE h2E2 CS-1103	Cariprazine Mirtazapine Clavulanic acid  Ketamine Exenatide BICX104/Bupropion	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
	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.

Cannabis Use Disorder

Cannabis Use Disorder

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

If you have questions, please contact Aidan Hampson.

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

If you have questions, please contact Will Aklin 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

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	Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment 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

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 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

• 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)