Notice Number: NOT-DA-20-001

Key Dates
Release Date: October 7, 2019

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this notice it to inform the scientific community of the availably of NIDA’s Division of Therapeutics and Medical Consequences (DTMC) program staff to provide technical assistant to investigators interested in the development of therapeutics to prevent and treat Substance Use Disorders and overdose.

The goal of the NIDA’s DTMC is to promote and support the development of safe and effective treatments for Substance Use Disorders (SUDs). Potential treatments include pharmacotherapies, immunotherapies, behavioral interventions, therapeutic devices, and digital therapeutics. The DTMC provides research support though peer-reviewed grants and contract resources.

The DTMC staff has expertise in chemistry, pharmacology, toxicology, pharmacokinetic/dynamics, drug formulation, animal and laboratory models of drug addiction, behavioral therapies, regulatory requirements, and all phases of clinical trials. Investigators from academic, nonprofit, pharmaceutical, and biotechnology organizations are encouraged to seek the technical assistance of the professional expertise of DTMC staff in all aspects of pre-clinical and clinical research of treatments for SUDs. These services are provided free of charge.

Further details on the DTMC, its research programs, organization information, and staff listings can be found here: https://www.drugabuse.gov/about-nida/organization/divisions/division-therapeutics-medical-consequences-dtmc.

NIDA has released specific funding opportunities designed to accelerate the development of therapeutics for the treatment of SUDs and to encourage research applications to support a diverse array of preclinical and/or clinical research projects. The goal of these funding opportunity announcements is to fund research that will have high impact and yield the necessary results to advance therapeutics closer to FDA approval. The following entities are eligible to apply: higher education institutions, nonprofits, for-profit organizations (e.g. pharmaceutical companies, small businesses, etc.), governments, and foreign institutions. Additional information on funding opportunities can be found here: https://www.drugabuse.gov/funding/nida-funding-opportunities. Relevant DTMC staff are ready to discuss what opportunities are most appropriate and provide information on how to apply for funding.

DTMC also provides access to NIDA-funded preclinical and clinical testing resources for academic and private sector partners to facilitate therapeutics development efforts. As an example, DTMC’s Addiction Treatment Discovery Program (ATDP; https://www.drugabuse.gov/about-nida/organization/divisions/division-pharmacotherapies-medical-consequences-drug-abuse-dpmcda/research-programs#ATDP) accepts compounds from both academic institutions and pharmaceutical companies for evaluation in relevant preclinical models based on the indicated substance use disorder and targeted aspect of addiction. To ensure confidentiality, testing is conducted under blinded conditions by contractors using NIDA-approved protocols. Individualized testing plans for submitted compounds are prepared collaboratively with the compound submitter and shaped by existing data. The ATDP evaluates compounds for effects on drug taking, relapse to drug seeking, drug withdrawal, and reward/anhedonia in established protocols to determine potential efficacy and liabilities. Compounds with completely novel mechanisms might be characterized in additional behavioral assays, including locomotor activity and drug discrimination. The ATDP also has the resources to develop behavioral assays for the evaluation of a compound as needed. In addition to the testing described above, in vitro selectivity assays and predictive safety tests are available, including in silico computational toxicology, the hERG channel assay to predict QT prolongation, the Spot Ames test to predict mutagenicity, and cytochrome P450 assays to predict drug interactions. Such testing can be used to facilitate lead selection and optimization.

Other contract resources can be used to conduct specialized safety pharmacology studies required by the FDA for potential treatments for SUDs. For compounds likely to advance to clinical trials for Cocaine Use Disorder, for example, it is important to assess the effects of the compound on the known cardiovascular actions of cocaine to avoid increasing lethality from cardiovascular complications. For opioids, similar studies could be conducted with endpoints to predict respiratory depression. When appropriate, NIDA can conduct these studies to facilitate compound advancement. Finally, contract resources ranging from GMP synthesis and standard preclinical safety testing to Phase I through III clinical trials can also be provided on a case-by-case basis, usually only for late phase projects with a high potential for success based upon company commitment of resources and expertise and for medication candidates with strongly supported preclinical efficacy data.

Inquiries

Please direct all inquiries to:

David A. White, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301.827.5981
Email: whitedav@nida.nih.gov