Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV

NCT ID: NCT06538285

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2026-06-30

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

Detailed Description

This is a single-arm pilot feasibility trial (N=12) of 3 doses of ketamine hydrochloride (0.50-0.75 mg/kg IM) administered approximately once weekly, in combination with 7 sessions of manualized psychotherapy for publicly insured patients with moderate-to-severe methamphetamine use disorder (MeUD) who have or are at-risk for HIV. Participants will be administered 3 preparatory psychotherapy visits over the 14 days prior to their first ketamine visit, a psychotherapy integration visit within 1-3 days following each ketamine visit, and a final integration visit about 1 week following their last ketamine visit. This 10-visit Ketamine-Assisted Psychotherapy (KAP) treatment intervention will last about 5 weeks in duration, and 2 follow-up assessment visits will be conducted at 4 and 12 weeks following KAP.

Participants will receive ketamine 0.50 mg/kg IM during their initial dosing visit, and either ketamine 0.50 mg/kg IM or 0.75 mg/kg IM at each subsequent dosing visit, depending on their toleration of prior dose(s).

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

Evaluations will be taken at baseline and each of the study visits.

The total duration of subject participation will be up to 119 days-including 5 weeks (i.e., 35 days) for the KAP intervention with follow-up assessment visits at 4 weeks (i.e., 28 days) and 12 weeks (i.e., 84 days) post-intervention.

The total duration of the study is expected to be 12 months.

Conditions

Methamphetamine Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine-Assisted Psychotherapy

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: 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).

Psychotherapy

Intervention Type: 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.

Interventions

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).

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Ketalar; Ketamine hydrochloride; Ketamine injection; Talk therapy; Therapy

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role: collaborator

California HIV/AIDS Research Program

OTHER

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Nicky Mehtani, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Nicky Mehtani, MD, MPH

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicky Mehtani, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco Department of Public Health

San Francicso, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

SFDPH Center for Substance Use and Health

Role: CONTACT

kare.study@sfdph.org

628-217-6319

Judy Tan, MPH

Role: CONTACT

Facility Contacts

John Farley

Role: primary

kare.study@sfdph.org

628-217-6319

References

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.

Reference Type: DERIVED

PMID: 40850924 (View on PubMed)

Other Identifiers

2KL2TR001870

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H24SB7788

Identifier Type: -

Identifier Source: org_study_id