Ketamine Therapy for Methamphetamine Use Disorder & HIV (KetaMet)

This single-arm pilot feasibility trial (n=12) will study the use of intramuscular (IM) ketamine (35-52.5mg/70kg) 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 study, conducted from January 2025 to April 2026, aims to assess the feasibility, acceptability, safety, and tolerability of ketamine-assisted psychotherapy (KAP) for MeUD. Participants will receive three monitored doses of IM ketamine (0.50-0.75 mg/kg) administered approximately once weekly, combined with seven sessions of manualized psychotherapy over a 5-week intervention period.

The initial dose will be 0.50 mg/kg IM, with subsequent doses adjusted based on tolerability. The study includes three preparatory psychotherapy visits, three ketamine administration sessions, four integration sessions, and two follow-up assessments at 4 and 12 weeks post-intervention. Participants will report their daily methamphetamine use before, during, and up to 3 months following the intervention. This Phase 2 trial, funded by a U.S. NIH Grant, seeks to establish initial evidence for the potential of KAP in treating MeUD and reducing HIV risk in publicly insured patients.

Trial Details

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.

NCT Number NCT06538285

Data attribution

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