NIH R01: Behavioral & Integrative Treatment Development Program

Funding Opportunity Number: PAR-24-299

Deadlines: February 5, 2025; March 5, 2025; May 7, 2025

Specific Areas of Research Interest

The overarching goal of this NOFO is to produce maximally efficacious behavioral interventions (individual and group) to treat substance use, promote medication/treatment adherence, and prevent HIV, and leverage new knowledge in neuroscience, new technologies and pharmacotherapies that may improve tangible outcomes of behavioral interventions. This NOFO underscores the importance of fostering research aimed at boosting intervention effects to produce targeted treatments across populations (including adolescents, pregnant women, individuals with comorbid psychiatric disorders) or populations with pain. Stages of treatment development will include Stage I, Stage II and Stage III efficacy studies (randomized clinical trials, adaptive designs, SMART designs, experimental therapeutics approach) of behavioral, combined, or integrated treatment interventions, adherence interventions, and prevention interventions for HIV risk behaviors. This includes treatment dose-response studies, and studies of the optimal sequencing of treatment, adherence, and HIV prevention interventions. Research on the treatment of SUDs involving illicit drugs, prescription medications, nicotine (including e-cigarette or vaping cessation), and multiple drugs. Of particular interest are studies that seek to determine basic mechanisms of behavior change, within the context of behavioral treatment research. Therefore, applicants are strongly encouraged to include (and if necessary, develop) measures of proposed mediators, moderators, and mechanisms of behavior change relevant to their intervention. This may include, for example, behavioral, cognitive, social, affective, and/or neurobiological targets. Grant applications submitted under this PAR should indicate and make explicit the stage of treatment development, as described above (hybrid studies are acceptable).

**Specific areas of interest include, but are not limited to:**Research to elucidate purported mechanism of action and targets of behavioral interventions at multiple levels of analysis. This includes determination of underlying biological and/or neurobiological mechanisms (e.g., as measured by imaging methodologies, skin conductance, or other biological/physiological indices) of the interventions associated with the behavioral, cognitive, affective, or social mechanisms of interventions.

  • Research that uses innovative technologies (digital therapeutics, including mobile applications and other platforms, virtual reality, wireless monitoring and biofeedback, imaging tools for biofeedback, artificial intelligence) to develop, improve and systematically measure behavioral interventions including the use of imaging methods to predict outcomes from behavioral interventions. Additionally, neuromodulation devices to augment behavior therapies.
  • Research that incorporates of genetic/epigenetic methodologies to help understand the variability in outcomes as result of therapeutic interventions.
  • Research that evaluates the use of medications to improve the efficacy of behavioral interventions.
  • Research on the essential components of a behavioral treatment, adherence, or therapist training intervention.
  • Stage II and III treatment development research aimed at facilitating the implementation of an intervention, testing behavioral interventions within primary care settings.
  • Research to promote adherence to pharmacotherapies, such as buprenorphine, methadone, depot naltrexone, naloxone, or HAART, in SUD treatment populations.
  • Studies that develop safe and effective psychosocial interventions to improve the outcomes of pharmacotherapies for SUDs including OUD and overdose reversal.
  • Research on tobacco harm reduction strategies such as switching from combustibles to e-cigarettes; studies to promote vaping quitting.
  • Research to adapt or modify scientifically supported SUD treatments, adherence interventions, or HIV prevention interventions for drug and alcohol users to enhance the application of and boosting treatment potency among health disparities populations.

For more information, please see the opportunity webpage.