Clinical Trial

Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

Study acronym: KARE
Completed Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn whether it is possible to use intramuscular (IM) ketamine 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 main questions it aims to answer are: * Do publicly insured patients find ketamine-assisted psychotherapy feasible and acceptable as a potential treatment for MeUD? * Is IM ketamine safe and tolerable among patients with MeUD? Participants will: * Receive 3 monitored doses of IM ketamine * Have 3 preparation and 4 integration psychotherapy visits * Report their daily amounts of methamphetamine used prior to, during, and up to 3 months following the intervention
Protocol Amendment History 2 changes
critical Trial completed 2026-08-13
notable Primary completion pushed: 2026-04 -> 2026-05-06 2026-06-06
Trial Details
NCT Number NCT06538285
Lead Sponsor Nicky Mehtani, MD, MPH
Collaborators: San Francisco Department of Public Health, California HIV/AIDS Research Program, National Center for Advancing Translational Sciences (NCATS)
Conditions Methamphetamine Use Disorder
Enrollment 17 participants
Start Date 2025-03-04
Primary Completion 2026-05-05 (estimated)
Study Completion 2026-06-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-12