RecruitingPhase 2NCT06538285

Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

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

Sponsor

Nicky Mehtani, MD, MPH

Enrollment

12 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Methamphetamine Use Disorder

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

Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether ketamine-assisted therapy can help people reduce or stop methamphetamine use, particularly among those who are also HIV-positive or at high risk for HIV. Ketamine is being studied as a way to reset addiction pathways in the brain. **You may be eligible if...** - You are aged 18–69 with moderate or severe methamphetamine use disorder - You want to reduce or quit methamphetamine use - You are insured by MediCal, MediCare, or Healthy San Francisco - You have HIV, are on PrEP, or recently engaged in HIV risk behaviors - You have been stably housed for at least 30 days or are in a residential drug program **You may NOT be eligible if...** - You do not have methamphetamine use disorder or do not want to reduce use - You do not have HIV risk factors or diagnosis - You do not have appropriate insurance coverage for the program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

Ketamine 0.50 mg/kg IM will be administered during the first dosing visit, and either 0.50 mg/kg IM or 0.75 mg/kg IM will be administered at the two subsequent dosing visits, depending on the participant's toleration of prior ketamine dose(s). All ketamine dosing visits will be facilitated by a licensed study therapist and clinician (i.e., NP or MD).

BEHAVIORALPsychotherapy

Psychotherapy will consist of three 1-hour preparatory talk therapy sessions over the 14 days preceding the first ketamine dosing visit, a 1-hour integration talk therapy session within 1-3 days following each ketamine dosing visit, and a final 1-hour integration talk therapy session about 1 week following the last ketamine visit. All talk therapy visits will be conducted by a licensed study therapist.