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NMDA Receptor Antagonist

Ketamine-Assisted Psychotherapy for Methamphetamine Addiction (KetaMet Trial)

Phase 2
Waitlist Available
Led By Nicky Mehtani, MD MPH
Research Sponsored by Nicky Mehtani, MD, MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age 18-69
* Moderate or severe methamphetamine use disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 119 days
Awards & highlights

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

Who is the study for?
This trial is for individuals with moderate-to-severe methamphetamine addiction who are publicly insured and either have HIV or are at risk for it. Participants will receive ketamine injections and undergo psychotherapy sessions to see if this combination helps reduce their meth use.
What is being tested?
The study tests the feasibility, acceptability, safety, and tolerability of intramuscular ketamine combined with psychotherapy as a treatment for methamphetamine use disorder in patients concerned with or at risk of HIV.
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of ketamine can include confusion, hallucinations, changes in blood pressure and heart rate, nausea, vomiting, dizziness, blurred vision and potentially others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 119 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 119 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability Questionnaire
Trial Completion
Trial Recruitment
Secondary study objectives
Adverse Events
Amphetamine Cessation Symptom Assessment
Antiretroviral Adherence
+10 more
Other study objectives
Attachment Insecurity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketamine-Assisted PsychotherapyExperimental Treatment2 Interventions
Participants will receive 3 administrations of intramuscular (IM) ketamine, dosed approximately once weekly, in combination with 7 psychotherapy visits over a 5-week treatment period. All ketamine dosing and psychotherapy visits will be conducted in-person in a designated therapy room.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120
Psychotherapy
2020
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

San Francisco Department of Public HealthOTHER_GOV
37 Previous Clinical Trials
36,037 Total Patients Enrolled
Nicky Mehtani, MD, MPHLead Sponsor
National Center for Advancing Translational Sciences (NCATS)NIH
332 Previous Clinical Trials
409,714 Total Patients Enrolled
~8 spots leftby Nov 2025
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