Related Announcements

PAR-21-183 - Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

There is an urgent public health need for the expansion of available therapeutic options for individuals with Opioid and Polysubstance Use Disorders as the efficacy of many treatments decrease over the long-term. The National Institute on Drug Abuse (NIDA) seeks applications that stimulate research to support the development and testing of Digital Therapeutics (DTx) to treat Opioid Use Disorders (OUD) or Polysubstance Use Disorders (PUD) as stand-alone interventions or integrated with FDA-approved medication treatments. In response to this public health need, the HEAL Initiative will consider funding scientifically meritorious applications that focus on evaluating the safety and/or the efficacy of digital therapeutics to opioid use disorders alone or in combination with other Substance Use Disorders (SUD) that are submitted in response to PAR-21-183.

Background

Although there are safe and effective FDA-approved pharmacotherapies for OUD (including buprenorphine, methadone, naltrexone), these therapies are underutilized and adherence is suboptimal. OUD pharmacotherapies can be used as standalone treatments, however labeling for these pharmacotherapies recommend that patients also receive behavioral therapy. Clinical evidence supports this recommendation. Digital therapeutics (DTx) are a relatively new modality to deliver behavioral treatments and represents an opportunity to provide behavioral interventions in a standardized, scalable and cost-effective manner. DTx have the potential to augment OUD treatments by improving medication adherence, or treatment retention. DTx may also act as stand-alone treatments and potentially provide alternatives to the current FDA-approved medications. DTx integrated with FDA-approved medications or as stand-alone treatments can be reviewed by FDA and obtain FDA clearance, enhancing opportunities for adoption by heath care systems and reimbursement by payers. The FDA has provided a pathway for authorization of DTx, which has already resulted in approved DTx for SUD. More work is needed on the clinical validation of DTx, as well as the expansion on the types of treatments delivered, the technologies used for delivery, the targeting of special populations or specific OUD and PUD, or other aspects that can increase the efficacy and reach of treatment using DTx.

This NOSI encourages, but is not limited to, research applications in the following areas:

• Development of a finalized version of the DTx and validation in Opioid or Polysubstance Use Disorder
• Interventions that effect efficacy related endpoints, such as craving, dependence, days of abstinence, medication adherence
• Interventions that effect behavioral endpoints as they relate to Opioid or Polysubstance Use Disorder, such as measures of working memory, impulsivity, risk-taking propensity, distress tolerance, self-regulation, stress reactivity
• Studies that assess dose range/treatment duration for the DTx intervention(s) and indicate it can be applied with acceptable safety, tolerability, adherence
• Studies that assess integration with an FDA-approved treatment, evaluating endpoints including SUD treatment adherence, efficacy or effects on other measures relevant to approving the treatment

Application and Submission Information

This notice applies to due dates on or after April 6, 2022 and subsequent receipt dates through December 7, 2023

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PAR-21-183 - Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-DA-22-056 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Will M.Aklin, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-869-1665
Email: aklinwm@mail.nih.gov

Peer Review Contact(s)

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov

Financial/Grants Management Contact(s)

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: (301) 480-1159
Email: pfleming@nida.nih.gov