Behavioral & Integrative Treatment Development Program (R01 Clinical Trial Optional)

The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications on the development and testing of behavioral and integrative treatments for drug and alcohol use, abuse, and dependence. This FOA reaffirms the continued commitment of NIDA to major programs of research on behavioral and integrative treatments. The term “behavioral treatments” is used here in a broad sense and includes but is not limited to psychotherapies, cognitive, relapse prevention, remediative, rehabilitative, skills training, counseling, family, and exercise therapies. Screening, brief, computerized, adherence, prevention interventions for HIV risk behaviors, and interventions that target therapist training and fidelity are included. Integrative refers to combinations with other treatments, including pharmacotherapies or other complementary approaches. The development and testing of putative targets and mechanisms of behavior change, as well as the use and development of valid and reliable assessment tools are crucial to the three stages of treatment research supported under this initiative:

Stage I (treatment generation, refinement) encompasses all activities related to the creation of a new behavioral intervention. This stage also includes the modification, adaptation, or refinement of an existing intervention (Stage IA). Stage I culminates in feasibility and pilot testing (Stage 1B). For example, one can conduct Stage I studies in research settings, with research therapists and research subjects, or in community settings with community providers.

Stage II (“Efficacy”) research consists of experimental testing of promising behavioral interventions in research settings, with research-based therapists/providers.

Stage III (“Efficacy in Real-World”) research consists of experimental testing of promising behavioral interventions in community settings, with community-based therapists/providers and patients, while maintaining a high level of control necessary to establish internal validity.

Stages I, II, and III all include a focus on theory-derived, targets/putative moderators, mediators, and change mechanisms that underlie the treatment, and studies that optimize combined, sequential, or integrated behavioral/pharmacological treatments.

DEADLINE : Letter of intent due date: 30 days prior to the application due date: Deadline: March 21, 2023