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:
Pharmacotherapies Development Program
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.
The Addiction Treatment Discovery Program (ATDP)
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. Such projects are managed by an interdisciplinary team with varied areas of expertise. 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 can evaluate compounds for effects on drug taking, reinstatement of drug seeking behavior, drug withdrawal, and reward/anhedonia in established models to determine potential treatment efficacy. Compounds can also be characterized in additional behavioral assays, including locomotor activity and drug discrimination, where appropriate. The ATDP has the capability to develop new models and modify existing 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
| Opioids | Cocaine | Cannabinoids (THC) |
|---|---|---|
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| Methamphetamine | Nicotine | Predictive Safety Testing |
|---|---|---|
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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 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 relevant behavioral data. Potential submitters are also encouraged to contact the program to suggest or submit novel compounds for evaluation based on a theoretical rationale for which there is supporting data.
Program Contact:
- Carol Hubner, Ph.D., Acting Director, ATDP, Phone 301-827-5926
ATDP Team and area(s) of expertise
- Evan Herrmann, Ph.D.*- Human behavioral pharmacology
- Feng Li, M.Sc., Ph.D.*- Drug design, formulation
- Mary MacDonald, Ph.D.- Drug design, SAR, computational toxicology, peptides
- Charles Marschke, B.S.- Compound registration, inventory control
- Matthew Seager, Ph.D.- Behavioral pharmacology
- Jason Sousa, Ph.D.*- PK/PD, ADME, Bioanalytical
- Drew Townsend, Ph.D.- Behavioral pharmacology
- David White, Ph.D.- Behavioral pharmacology
*At large ATDP Team member
Regulatory Affairs Program
The Regulatory Affairs Program offers regulatory expertise and support to academic and industry investigators interested in/or developing compounds, devices, or digital therapeutics for Substance Use Disorders. The goal is to assist investigators to advance therapeutic interventions through the U.S. FDA regulatory pathway. This includes but it is not limited to assisting with filing and maintenance of Investigational New Drug (IND) applications, Drug Master Files (DMFs), New Drug Applications (NDAs), and Investigational Device Exemptions (IDEs). The ultimate goal of this program is to provide all the required technical assistance to investigators to file and/or obtain approval of New Drug Applications (NDAs) or other types of market approvals for medications, devices, or digital therapeutics applications.
Program Contacts:
- Marta De Santis, Ph.D., Program Lead, Phone - 301-827-5922
- Julia Donnelly, M.S., RAC, Phone – 301-451-7262
- Jennifer Wong, Ph.D., Phone - 301-827-6267
Behavioral Therapy Development Program
The Behavioral Therapy Development Program (BTDP) within the DTMC supports all stages of development of behavioral interventions for the treatment of Substance Use Disorders (SUD). They include: Stage I (treatment generation, refinement), Stage II (efficacy) and Stage III (efficacy in the real-world) clinical trials. The Program also includes the development of integrative interventions that involve the development of a behavioral therapy to improve the effect of a pharmacological treatment or a therapeutic device. Of particular interest are studies that seek to determine mechanisms of behavior change, within the context of behavioral treatment research. This may include, for example, behavioral, cognitive, social, affective, and/or neurobiological targets as well as the use of neuroimaging tools to investigate the effects of behavioral interventions on the brain. The goal of the BTDP is to advance the development of safe and effective behavioral interventions to treat SUDs and to study the most effective approach to disseminate in the general populations those interventions that have demonstrated safety and efficacy. Investigators interested in submitting grant applications in this area of research are encouraged to review the Behavioral & Integrative Treatment Development Program (R01 and R34).
Program Contacts:
- Will M. Aklin, Ph.D. - Phone: 301-827-5909
- Evan Herrmann, Ph.D. - Phone: 301-827-6406
- Tanya Ramey, MD, Ph.D. - Phone: 301-827-5944
Device Development for Substance Use Disorders
This program encourages the development of devices to treat substance use disorders. Recent and continuing advances in technology offer unprecedented opportunities to develop neuromodulatory or neurophysiological devices that are safe and effective SUD treatments. Devices offer unique opportunities, for example, to directly modulate neurocircuitry to affect interactions between brain regions, potentially altering behavioral responses to drugs of abuse. Technologies of interest include, but are not limited to, transcranial magnetic stimulation, transcranial electric stimulation, vagal nerve stimulation, deep-brain stimulation, and others. DTMC is interested in research that connects the mechanism of the intervention to the behavioral response and efficacy studies of sufficient size to validate the effect of the device. Researchers interested in developing devices to treat substance use disorders can contact DTMC staff to discuss preclinical or clinical studies to test the intervention, as well as how to work with regulatory agencies to ultimately submit the intervention for review. DTMC has an active funding opportunity that provides a staged pathway for developing and testing devices: Device-Based Treatments for Substance Use Disorders
Program Contacts:
- Will M. Aklin, Ph.D. - Phone: 301-827-5909
- Jennifer Wong, Ph.D. - Phone: 301-827-6267
Digital Therapeutics Development Program
The Digital Therapeutics Development Program takes advantage of the growing opportunities in remotely delivering effective interventions for substance use disorders. Digital therapeutics are mobile, web, or other software-based platforms that can deliver behavioral interventions which originally may have required face-to-face interactions with a therapist. Digital therapeutics provide several advantages to in-person treatment, such as the delivery of a behavioral intervention reliably and consistently with limited staff training, scalability, and they eliminate or minimize travel to a clinician by reaching patients where they live. In addition, remote delivery allows for enhanced privacy with discreet and confidential care, helping to address the stigma associated with SUDs and its treatment. The submission of digital therapeutics to the FDA for review and authorization is strongly encouraged by DTMC. Researchers interested in developing digital therapeutics to treat substance use disorders can contact DTMC staff to discuss the design of the intervention or clinical studies to test the intervention, as well as how to work with regulatory agencies to ultimately submit the intervention for review. DTMC has an active funding opportunity that provides a staged pathway for developing and testing digital therapeutics: Developing Digital Therapeutics for Substance Use Disorders
Program Contacts:
- Will M. Aklin, Ph.D. - Phone: 301-827-5909
- Evan Herrmann, Ph.D. - Phone: 301-827-6206
Clinical Trial Outcomes Development Program
The mission of the Clinical Trial Outcomes Development Program (CTOPD) is to advance the development of novel clinical outcome assessment (COA) measures and instruments that can be used to evaluate the safety and efficacy endpoints in clinical trials of treatments for substance use disorders. There is a critical need to develop reliable, valid, and widely accepted COAs to advance drug development by assessing a broader range of relevant clinical outcomes in substance use disorders, and the goal of CTODP is to meet this public health need. The program supports the research and development of COAs related both to the existing and new clinical trial endpoints that are related to substance use disorders.
Program Contacts:
- Tanya Ramey, MD, Ph.D. - Phone: 301-827-5944
- Ivan Montoya, M.D., M.P.H. - Acting Director - Phone: 301-827-5936