Combined Neuromodulation and Behavioral Treatment Algorithm Development for Stimulant Use Disorder (StUD) Enriched for Vulnerable Phenotype (U01 Clinical Trial Required)

Background
Stimulant Use Disorder (StUD) still does not have FDA-approved treatments. Neuromodulation, such as transcranial magnetic stimulation (TMC) and transcranial direct current stimulation (tDCS), has been successfully used for major depressive disorder and obsessive-compulsive disorder. The purpose of this grant is to support the development of neuromodulatory devices with behavioral treatment as a component for StUD, targeting patients with vulnerable phenotype including those with reported qualitatively high levels of impulsivity, compulsivity, and cognitive dysfunction.

Grant Details
The grant aims to develop safe and effective treatments for StUD by proposing a clinical trial of the combination of any NIBS that can include TMS, tDCS, Alternating Current Stimulation, LIFU, paired with behavioral treatment such as CBT, mindfulness, contingency management. The studies proposed should identify and validate known as well as new neuromodulation targets and provide a comprehensive rationale of the behavioral and neurobiological effects of stimulation of these targets selection and their constituent brain networks.
The grant also supports the investigation of the effect of the proposed combination approach of neuromodulation and behavioral treatment on the indices of efficacy in a larger well-powered study.

Eligibility Requirements
All organizations administering an eligible parent award may apply for a supplement under this NOFO. Eligible organizations include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, federal government agencies, U.S. territories or possessions, independent school districts, public housing authorities/Indian housing authorities, native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations, regional organizations, foreign organizations.

Period of Performance
The project period is limited to 5 years with an earliest start date in November 2024 and an expiration date in November 2024.

Grant Value
NIDA intends to commit $2,000,000 in FY 2025 to fund three to five awards. Application budgets are limited to $500K per year for direct costs but need to reflect the actual needs of the proposed project.