Status:
RECRUITING
Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV
Lead Sponsor:
Nicky Mehtani, MD, MPH
Collaborating Sponsors:
San Francisco Department of Public Health
California HIV/AIDS Research Program
Conditions:
Methamphetamine Use Disorder
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
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) ...
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 psych...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06538285
Start Date
March 4 2025
End Date
June 1 2026
Last Update
April 4 2025
Active Locations (1)
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1
San Francisco Department of Public Health
San Francicso, California, United States, 94102