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Research Programs

In 1989, the U.S. Congress statutorily mandated that a Medications Development Program (MDP) be established within NIDA.  In 1990, NIDA created the Medications Development Division (MDD) (now the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA)) to operationalize the goals of the MDP.

The DPMCDA is modeled after a typical pharmaceutical company with the ability to conduct all phases of medications development from synthesis and screening of potential drug entities to preparing submissions for New Drug Applications. The DPMCDA funds research and development, through peer reviewed grants and contracts, and interagency agreements to support the complex medications development process and clinical trial infrastructure.

Compounds acquired via an agreement with pharmaceutical companies and/or academic or government laboratories are tested in the MDP preclinical contract programs such as the Addiction Treatment Discovery Program (ATDP) in order to ascertain their suitability for further consideration as potential clinical candidates. Compounds supplied by industry, academia, or government may enter at any stage of development. As a potential medication graduates from the toxicology program, or a collaborative agreement is formed for a marketed medication, medications are then tested in our Clinical Trials Program (cocaine, opiate, and methamphetamine).

The Addiction Treatment Discovery Program (ATDP)

Mission Statement: To discover potential pharmacological treatments for substance abuse, with an emphasis on relapse prevention, in humans through preclinical testing and evaluation of compounds.

The ATDP accepts compounds from specific pharmacological classes and for which there is preliminary data. Compounds of known pharmacology are profiled in relevant animal models, which will vary depending upon the compound's mechanism of action. Because of the focus on relapse prevention as a clinical endpoint, the program has a number of reinstatement models using different drugs of abuse. The ATDP has increased resources to evaluate compounds in models of relapse to cocaine, heroin or methamphetamine, using stress, conditioned cues, or drug primes to produce reinstatement in rats whose self-administration behavior has been extinguished. Compound testing is shaped by existing data in rodents and the sequence of testing is determined in collaboration with the compound submitter.

Compound Testing: The ATDP uses several decision-trees for testing, depending upon the compound mechanism. The following screening and profiling protocols are available:

  • Locomotor Activity acute and timecourse tests (mice)
  • Drug Discrimination acute and timecourse tests by several routes of administration (rats and/or primates)
  • Self-Administration (rats and/or primates)
  • Stress - or Conditioned Cues, or Drug-Priming-Induced Reinstatement (rats)

In addition, established tests that could be selected for a particular compound include in vitro receptor assays as well as a series of predictive toxicology tests, such as the hERG channel assay to predict QT prolongation and the Spot Ames test to predict mutagenicity. As necessary, additional animal models may be established.

Compound testing is conducted free of charge to compound submitters through an array of NIDA contracts and interagency agreements. Compounds are tested under blinded conditions and test results are forwarded to compound submitters, who retain all publication rights to the data.

Program Contact: David White, Ph.D., Director, ATDP (301) 443-8889

Cocaine Clinical Trials Program (CCTP)

cocaine molecule

Mission Statement: To identify, evaluate, and develop effective pharmacotherapies for the treatment of cocaine dependence.

Program Functions: To identify new compounds/medications as potential pharmacotherapies; to evaluate brain imaging techniques as potential adjunctive diagnostic or screening tools and as potential treatment evaluation tools; to design, conduct, analyze, and review clinical trials for the combined pharmacotherapy and behavioral therapy of cocaine abuse; to develop and evaluate new biological or surrogate measures to assess the outcomes of pharmacotherapeutic trials.

Program Accomplishments: Through an established testing program involving contract and grant mechanisms, several cocaine pharmacotherapies have been identified and are in confirmatory clinical testing. Through interaction with leading substance abuse experts in academia, the pharmaceutical industry, and the FDA, this program has developed standardized outcome measures and success criteria for clinical pharmacotherapy trials, established clinical algorithms and standards for the conduct of exploratory clinical concept studies; human drug interaction studies; and Phase I, II, and III safety and efficacy studies.

Program Contact: Liza Gorgon, M.A., Clinical Trials Specialist

Opiate Clinical Trials Program (OCTP)

Mission Statement: To identify, evaluate, and develop effective pharmacotherapies for the treatment of opiate dependence.

Program Functions: To identify new compounds/medications as potential pharmacotherapies; to evaluate brain imaging techniques as potential adjunctive diagnostic or screening tools and as potential treatment evaluation tools; to design, conduct, analyze, and review clinical trials for the combined pharmacotherapy and behavioral therapy of opiate abuse; to develop and evaluate new biological or surrogate measures to assess the outcomes of pharmacotherapeutic trials.

Program Accomplishments: Through an established testing program involving contract and grant mechanisms, several opiates pharmacotherapies have been approved for marketing (LAAM, buprenorphine, buprenorphine/naloxone). Through interaction with leading substance abuse experts in academia, the pharmaceutical industry, and the FDA, this program has developed standardized outcome measures and success criteria for clinical pharmacotherapy trials, established clinical algorithms and standards for the conduct of exploratory clinical concept studies; human drug interaction studies; and Phase I, II, and III safety and efficacy studies.

Program Contact: Ivan Montoya, M.D., Deputy Director, DPMCDA

Methamphetamine Clinical Trial Group Program (MCTGP)

Mission Statement: To identify, evaluate, and develop effective pharmacotherapies for the treatment of methamphetamine dependence.

Program Functions: To conduct Phase I, II and III clinical trials to evaluate the clinical, pharmacological, efficacy, and safety profiles of selected compounds and behavioral therapies that may be effective for the treatment of methamphetamine abuse and addiction.

Program Accomplishments: Following the Methamphetamine Think Tank ( MATTT) meeting in 2000, NIDA facilitated development of the Methamphetamine Clinical Trials Group (MCTG). Through collaboration with the MCTG, multiple interactions with leading substance abuse experts, the pharmaceutical industry and the FDA, several studies have been completed and additional protocols have been approved for further evaluation for Phase I and II clinical trials.

Program Contact: David McCann, Ph.D., Chief (acting), Clinical/Medical Branch

Medical Consequences of Drug Abuse and Co-occurring Infections Program

Medical Consequences of Drug Abuse and Co-occurring Infections program within the DPMC supports domestic and international clinical research on all physiological systems, except CNS (e.g., memory, neurological/neurocognitive aspects, NeuroAIDS) in drug abusers with or without co-occurring infections including HIV, Hepatitis C, and other hepatic viruses, TB, STDs and others.

Program Contact: Jag Khalsa, Ph.D., Chief. Medical Consequences Branch, phone (301) 443 2159

Medications Research Grants

The Medications Research Grants program plans and supports extramural research grants to test medications for the treatment of drug abuse and dependence disorders in several key areas: controlled compound assessment clinical pharmacology studies, controlled clinical trials for new treatment agents or new indications for marketed medications and clinical studies of the pharmacological effects and interactions among experimental addiction medications and medications for associated medical conditions and psychotherapeutic agents. Also supports experimental pharmacotherapy studies to enhance the efficacy of approved marketed medications, and experimental pharmacotherapy studies of psychotropic or other medications used in the treatment of mental disorders in drug dependent individuals including drug-induced or drug-related mental disorders.

Program Contact: Jamie Biswas, Ph.D., Chief, Medications Research Grants Branch, phone (301) 443-8096

Immunotherapy

The program also supports research on immunotherapy for the treatment and prevention of drug abuse. This includes preclinical and clinical studies to determine the immunogenicity, specificity, protective effects, behavioral pharmacological effects, toxicity, safety, and efficacy, of vaccines and monoclonal antibodies for potential use as immunotherapies for the treatment of substance use disorders.

This page was last updated December 2013