Clinical TrialSubstance Use Disorders (SUD)KetamineRecruiting

Ketamine Therapy for Methamphetamine Use Disorder & HIV (KetaMet)

Single-arm pilot feasibility trial (n=12) of intramuscular ketamine (0.50–0.75 mg/kg IM, 3 doses ~once weekly) combined with manualised psychotherapy (7 sessions) for publicly insured patients with moderate-to-severe methamphetamine use disorder who have or are at-risk for HIV.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Single-group, Phase II feasibility study (N=12) delivering three monitored IM ketamine doses (initial 0.50 mg/kg, subsequent 0.50 or 0.75 mg/kg as tolerated) approximately once weekly alongside seven manualised psychotherapy sessions over ~5 weeks to publicly insured patients with moderate-to-severe methamphetamine use disorder and HIV risk or diagnosis.

Outcomes include feasibility and acceptability, safety/tolerability, and changes in methamphetamine use measured daily pre-, during, and up to 3 months post-intervention with follow-up visits at 4 and 12 weeks.

Study Protocol

Preparation

3 sessions
60 min each

Dosing

3 sessions

Integration

4 sessions
60 min each

Therapeutic Protocol

other

Study Arms & Interventions

Ketamine-Assisted Psychotherapy

experimental

3 IM ketamine administrations (~once weekly) combined with manualised psychotherapy (3 preparatory + 4 integration visits) over a ~5-week treatment period.

Interventions

  • Ketamine0.5 - 0.75 mg/kg
    via IM• weekly• 3 doses total

    Initial 0.50 mg/kg; subsequent doses may be 0.50 or 0.75 mg/kg per tolerability.

  • Compound
    via Other• 7 sessions

    Manualised psychotherapy: three 1-hour preparatory sessions, integration visit within 1–3 days after each ketamine session, plus a final 1-hour integration ~1 week after last session.

Participants

Ages
18 – 69
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2025-01-01
    End: 2026-04-01
  • Compound
    Ketamine
  • Topic
    Substance Use Disorders (SUD)

Locations

San Francisco Department of Public Health — San Francicso, California, United States

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