Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

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

Conditions

• Methamphetamine Use Disorder

Interventions

DRUG

Ketamine

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).

BEHAVIORAL

Psychotherapy

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.

Sponsors & Collaborators

• San Francisco Department of Public Health

  collaborator OTHER_GOV

• California HIV/AIDS Research Program

  collaborator OTHER

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Nicky Mehtani, MD, MPH

  lead OTHER

Principal Investigators

• Nicky Mehtani, MD MPH · University of California, San Francisco

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-04

Primary Completion

2026-04-30

Completion

2026-07-31

FDA Drug

Yes

Countries

• United States