Using ketamine and therapy to help people with methamphetamine addiction and HIV
Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
This study is testing whether giving ketamine along with therapy can help people with methamphetamine addiction who also have or are at risk for HIV.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francicso, California) |
| Trial ID | NCT06538285 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the feasibility and safety of intramuscular ketamine combined with psychotherapy for treating moderate-to-severe methamphetamine use disorder in publicly insured patients who have or are at risk for HIV. Participants will receive three doses of ketamine along with multiple psychotherapy sessions over a five-week period. The study will monitor participants' methamphetamine use and assess their experiences with the treatment. The trial will include follow-up assessments to evaluate the long-term effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-69 with moderate to severe methamphetamine use disorder who are publicly insured and have or are at risk for HIV.
Not a fit: Patients who do not have methamphetamine use disorder or are not at risk for HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for individuals struggling with methamphetamine addiction and HIV.
How similar studies have performed: While this approach is relatively novel, there is emerging evidence suggesting that ketamine-assisted therapies may be beneficial for substance use disorders.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francicso, California
- San Francisco Department of Public Health — San Francicso, California, United States (Recruiting)
Study contacts
- Principal investigator: Nicky Mehtani, MD MPH — University of California, San Francisco
- Study coordinator: SFDPH Center for Substance Use and Health
- Email: kare.study@sfdph.org
- Phone: 628-217-6319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.