Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV
Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
Nicky Mehtani, MD, MPH
12 participants
Mar 4, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria13
- 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 Criteria21
- 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
Interventions
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 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06538285