Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction (KARE)

NCT06538285 Phase 2 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Nicky Mehtani, MD, MPH
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	17
Start date	2025-03-04
Completion	2026-07

Conditions

• Methamphetamine Use Disorder

Interventions

• Ketamine
• Psychotherapy

Primary outcomes

• Trial Recruitment — Up to 28 days
  Binary trial feasibility outcome of whether prospective participants undergoing in-person screening (V0) are found to be fully eligible and ultimately enroll in the study (V1).
• Trial Completion — Up to 35 days
  Binary trial feasibility outcome of whether enrolled participants complete at least 70% of KAP intervention visits (i.e., Visits #1-10)
• Acceptability Questionnaire — Up to 35 days
  At the end of the KAP intervention (i.e., V10), participants will be administered an 8-item, 5-point-scale questionnaire based off of the Sekhon Theoretical Framework of Acceptability to evaluate eight distinct aspects of the acceptability of the intervention. Higher scores indicate greater levels of intervention acceptability.

Countries

United States