Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

NCT06538285 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: H24SB77882KL2TR001870
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; Methamphetamine withdrawal; Ketamine-assisted therapy; Psychedelic; Sexual Behavior; Methamphetamine; Ketamine-assisted psychotherapy; Chemsex

Outcome Measures

Primary Outcomes (3)

• Trial Recruitment

  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).

  Up to 28 days

• Trial Completion

  Binary trial feasibility outcome of whether enrolled participants complete at least 70% of KAP intervention visits (i.e., Visits #1-10)

  Up to 35 days

• Acceptability Questionnaire

  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.

  Up to 35 days

Secondary Outcomes (11)

• Adverse Events

  Up to 119 days

• Blood Pressure

  Up to 28 days

• Heart Rate

  Up to 28 days

• Methamphetamine Use by Timeline Follow Back

  Up to 119 days

• Methamphetamine Cravings

  Up to 119 days

Other Outcomes (1)

• Attachment Insecurity

  Up to 119 days

Study Arms (1)

Ketamine-Assisted Psychotherapy

EXPERIMENTAL

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.

Drug: Ketamine; Behavioral: Psychotherapy

Interventions

Ketamine DRUG

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).

Also known as: Ketalar, Ketamine hydrochloride, Ketamine injection

Ketamine-Assisted Psychotherapy

Psychotherapy BEHAVIORAL

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.

Also known as: Talk therapy, Therapy

Ketamine-Assisted Psychotherapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-69
• Moderate or severe methamphetamine use disorder
• Interest in reducing or stopping methamphetamine use
• Insured by MediCal, MediCare, or Healthy San Francisco
• Used methamphetamine ≥7 out of the 30 days prior to screening OR enrolled in a residential drug treatment program
• Have a diagnosis of HIV OR taken PrEP over the last 90 days OR engaged in ≥1 risk behavior for HIV acquisition/transmission over the last 90 days (i.e., anal sex under the influence of methamphetamine, condomless sex with a partner of serodiscordant or unknown HIV status, or any shared use of injection drug supplies)
• English speaking
• Permanently housed for ≥30 days OR enrolled in residential drug treatment for ≥5 days
• Have a text-capable cell phone or access to email (if not enrolled in residential treatment)
• Able and willing to provide informed consent and adhere to visit schedule
• If necessary, willing to be contacted on a daily basis by one of the therapists for 7 days after each ketamine session
• Prior to scheduled ketamine sessions, agree: (a) abstain from using methamphetamine and cocaine for ≥48 hours, (b) abstain from using non-prescribed opioids, cannabis products, benzodiazepines, or alcohol for ≥24 hours, (c) consume no more than a modest quantity (e.g., 1 cup) of caffeine (e.g., coffee or tea) in the morning; (d) continue usual regimen of routinely prescribed opioid-based medications throughout trial; and (e) continue any routine behavioral or pharmacologic mental health interventions as usual outside of the trial
• Female-born participants of child-bearing potential with male-born partners and male-born participants with female-born partners of child-bearing potential must agree to use highly effective contraception for at least 1 month prior to and 2 months after ketamine administration

You may not qualify if:

• Significant prior use of ketamine for non-anesthetic purposes, as determined by the investigators
• Cognitive impairment sufficient to impede the ability to complete study tasks
• Lifetime history of intracranial hemorrhage
• Has an intracranial mass
• Had a stroke in the past 12 months
• Had a seizure in the past 6 months
• Has current psychosis or any lifetime history of schizophrenia or schizoaffective disorder
• Engaged in a contingency management program during study
• Taking any prohibited medications
• Active suicidal ideation with intent
• Baseline hypertension (≥150 SBP or ≥90 DBP) after repeated measurements
• History of aneurysmal vascular disease, dissection or arteriovenous malformation
• Had a cardiac arrest or myocardial infarction in the past 12 months
• QTc \>450 msec on 12-lead EKG (Bazett's formula)
• Has a clinically significant arrhythmia

Sponsors & Collaborators

• Nicky Mehtani, MD, MPH: lead
• San Francisco Department of Public Health: collaborator
• California HIV/AIDS Research Program: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

San Francisco Department of Public Health

San Francicso, California, 94102, United States

Location

Related Publications (1)

• Mehtani NJ, Anderson BT, Alexander I, Hendricks PS, Mitchell JM, Coffin PO, Johnson MO. Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks. BMJ Open. 2025 Aug 24;15(8):e100775. doi: 10.1136/bmjopen-2025-100775.

  PMID: 40850924 DERIVED

MeSH Terms

Conditions

Sexual Behavior; Chemsex

Interventions

Ketamine; Psychotherapy; Therapeutics

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Behavioral Disciplines and Activities

Study Officials

• Nicky Mehtani, MD MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: March 4, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)