This single-arm pilot feasibility trial (n=12) will study the use of intramuscular (IM) ketamine (35-52.5mg/70kg) in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at risk for HIV disease.
The study, conducted from January 2025 to April 2026, aims to assess the feasibility, acceptability, safety, and tolerability of ketamine-assisted psychotherapy (KAP) for MeUD. Participants will receive three monitored doses of IM ketamine (0.50-0.75 mg/kg) administered approximately once weekly, combined with seven sessions of manualized psychotherapy over a 5-week intervention period.
The initial dose will be 0.50 mg/kg IM, with subsequent doses adjusted based on tolerability. The study includes three preparatory psychotherapy visits, three ketamine administration sessions, four integration sessions, and two follow-up assessments at 4 and 12 weeks post-intervention. Participants will report their daily methamphetamine use before, during, and up to 3 months following the intervention. This Phase 2 trial, funded by a U.S. NIH Grant, seeks to establish initial evidence for the potential of KAP in treating MeUD and reducing HIV risk in publicly insured patients.
Trial Details
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Sponsors & Collaborators
University of California San FranciscoAt UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.