Federal Project Grant Award Summary

The National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), awarded a $2.46 million Project Grant to the University of California, San Francisco on July 15, 2026, with completion scheduled for June 30, 2030. This award funds the first placebo-controlled trial of psilocybin therapy for methamphetamine use disorder (MEUD) in people with HIV (PWH), and the first outpatient psilocybin therapy trial for this condition in the United States. The research deliverables include a double-blind, randomized pilot study enrolling 30 PWH participants with moderate-to-severe MEUD, who will receive either 25 mg or 1 mg oral psilocybin embedded within a manualized 6-week motivational enhancement therapy framework.

The project will produce feasibility, acceptability, and safety assessments based on pre-defined benchmarks, as well as qualitative analysis of post-intervention semi-structured participant interviews. Exploratory outcomes will examine changes in substance use patterns and related psychosocial measures. This research addresses a critical public health gap, as methamphetamine use among PWH contributes to antiretroviral therapy non-adherence and HIV viremia while lacking FDA-approved treatments. The trial investigates psilocybin's potential anti-addictive effects through its serotonergic mechanisms, building on emerging evidence from early-phase studies showing reductions in alcohol, tobacco, and cocaine use.