RECRUITING

Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06538285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 69 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * If receiving any medication that may cause blunting of responses or diminished affect, such as antipsychotics, exclusion will be as per the evaluation of the PI and study staff * 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 * Meets any of the following laboratory parameters: ALT ≥3x ULN, AST ≥3x ULN, total bilirubin ≥1.5x ULN, eGFR \<30mL/min by CKD-EPI or currently on dialysis * Pregnant, breastfeeding, or unwilling to use birth control during the study * Pending legal proceedings with a high risk for incarceration during the study * Taken another investigational drug in the past 30 days * Has any physical or mental health condition which, per the clinical judgment of the investigators, interferes with safe study participation or adherence to study procedures

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* If receiving any medication that may cause blunting of responses or diminished affect, such as antipsychotics, exclusion will be as per the evaluation of the PI and study staff
* 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
* Meets any of the following laboratory parameters: ALT ≥3x ULN, AST ≥3x ULN, total bilirubin ≥1.5x ULN, eGFR \<30mL/min by CKD-EPI or currently on dialysis
* Pregnant, breastfeeding, or unwilling to use birth control during the study
* Pending legal proceedings with a high risk for incarceration during the study
* Taken another investigational drug in the past 30 days
* Has any physical or mental health condition which, per the clinical judgment of the investigators, interferes with safe study participation or adherence to study procedures

Contacts and Locations

Study Contact

SFDPH Center for Substance Use and Health

CONTACT

628-217-6319

kare.study@sfdph.org

Judy Tan, MPH

CONTACT

Principal Investigator

Nicky Mehtani, MD MPH

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

San Francisco Department of Public Health

San Francicso, California, 94102

United States

Collaborators and Investigators

Sponsor: Nicky Mehtani, MD, MPH

Nicky Mehtani, MD MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-02

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Methamphetamine Use Disorder