In 1989, Congress mandated the establishment of the Pharmacotherapies Development Program within NIDA. As a result of this mandate, in 1990 NIDA created the Medications Development Division, now the Division of Therapeutics and Medical Consequences (DTMC), to operationalize the goals of the program.
The DTMC supports and conducts studies to evaluate the safety and efficacy of pharmacotherapies, behavioral therapies, and devices to treat Substance Use Disorders (SUDs). The DTMC models aspects of a pharmaceutical company, with the resources to conduct and support all phases of medications development including synthesis and preclinical evaluation of potential therapeutics, clinical trial design and execution, and preparing regulatory submissions. The Division also supports research on behavioral therapies to treat substance use disorders as well as research on the medical consequences of drug abuse. The Division funds these efforts through peer reviewed grants, contracts, and interagency agreements. Further details on the Division’s programs are provided below:
The Pharmacotherapies Development Program integrates the expertise of multiple Branches to facilitate the advancement of novel medications (small molecules and biologics) from lead selection through clinical safety and efficacy studies in substance use disorders (SUDs). Projects focused on cocaine, methamphetamine and marijuana use disorders are a high priority for NIDA because there are currently no FDA-approved treatments for these indications. While multiple medications are available to treat opioid use disorders, the ongoing opioid overdose epidemic underscores a need for improved treatment options. Likewise, the high failure and relapse rates seen with currently available smoking cessation products argue for an expansion of treatment options. NIDA is poised to facilitate the advancement of such projects through grant and/or contract support (a detailed description of opportunities to access NIDA contract testing through the Division’s Addiction Treatment Discovery Program is provided immediately below). Moreover, DTMC staff can provide advice on all phases of development (data interpretation, regulatory requirements, study design - preclinical and clinical) at no cost to the sponsor (including academic, pharmaceutical and biotechnology organizations) to assist in advancing relevant programs. These services are provided for both NIDA funded and externally supported programs.
Program contacts: Please review the Division’s Branch listing and select the Branch that appears most appropriate for a given project’s stage of development.
Mission Statement: To identify, evaluate, and recommend potential pharmacotherapies for the medical management of substance use disorders through preclinical testing by laboratories in an existing framework of contracts maintained by NIDA.
The ATDP accepts compounds from pharmaceutical companies, academic institutions, and government laboratories for evaluation, in preclinical models relevant to substance use disorders. Testing is conducted under blinded conditions by contractors using protocols developed in collaboration with NIDA. Individualized testing plans for each submitted compound are prepared collaboratively with the compound submitter based upon the compound’s mechanism of action and existing data. The ATDP may evaluate compounds for effects on drug taking, relapse to drug seeking, drug withdrawal, and reward/anhedonia in established models to determine potential efficacy. Compounds with novel mechanisms might be characterized in additional behavioral assays, including locomotor activity and drug discrimination. The ATDP has the capability to develop and modify behavioral assays for the evaluation of a particular compound as needed. For a comprehensive list, see the table below.
NIDA’s Addiction Treatment Discovery Program Testing Capabilities
|Methamphetamine||Nicotine||Predictive Safety Testing|
Note: Additional behavioral assays not listed in the table above can be developed on an as-needed basis.
In addition to the testing described above, in vitro assays and predictive safety assessments are available, including in silico computational toxicology, a comprehensive in vitro proarrhythmia assay (CiPA) to predict cardiac risk, the Spot Ames test to predict mutagenicity, and cytochrome P450 assays to predict potential drug interactions. Such testing can be used to facilitate lead selection and optimization and to de-risk potential development candidates.
Compound evaluation is conducted through NIDA contracts and interagency agreements that are blinded as to compound identity or source and is free of charge to compound submitters. Test results are considered confidential and complete reports and data tables are forwarded to submitters, who retain all rights to the data.
The ATDP is interested in evaluating compounds with potential efficacy for substance use disorders including cocaine, methamphetamine, nicotine, and opioids, based upon their interactions with either specific targets and pathways or behavioral data. Potential submitters are also encouraged to contact program to suggest or submit novel compounds for evaluation based on a theoretical rationale for which there is supporting data.
David White, Ph.D., Director, ATDP
Phone: (301) 827-5981, E-mail: email@example.com
The Regulatory Affairs Branch (RAB) serves as the Division’s primary contact to the U.S. Food and Drug Administration (FDA). In this capacity, the RAB conducts the filing of Investigational New Drug (IND) applications, Drug Master Files (DMFs) and supporting documents as new medications enter or complete clinical studies. The RAB ensures that DTMC's studies are in compliance with all applicable U.S. regulatory requirements. Consultation and advice on regulatory requirements, nonclinical and clinical medication development requirements, and strategy is provided to NIDA grantees, potential development partners, federal agencies, contractors, and other interested parties regarding projects of mutual interest.
Program Contact: Robert Walsh, Chief, Regulatory Affairs Branch, phone (301) 827-5244 and e-mail: firstname.lastname@example.org.
The Behavioral Therapy Development Program within the DTMC supports Stage I (treatment generation, refinement), II (efficacy) and III (efficacy in the real-world) research. Research to test efficacy, examine theory-derived targets/mechanisms of behavior change that underlie treatment, and studies that optimize combined, sequential, or integrated behavioral/pharmacological treatments are supported.
Program Contact: Will M. Aklin, Ph.D., Research Grants Branch, phone (301) 827-5909