Ketamine Therapy for Methamphetamine Use Disorder & HIV
NCT Number: NCT06538285
Acronym: KetaMet
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Methamphetamine Use Disorder
Interventions: DRUG: Ketamine|BEHAVIORAL: Psychotherapy
Sponsor: Nicky Mehtani, MD, MPH
Collaborators: San Francisco Department of Public Health|California HIV/AIDS Research Program|National Center for Advancing Translational Sciences (NCATS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01
Completion Date: 2026-04
Locations: San Francisco Department of Public Health, San Francisco, California, 94102, United States

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

Primary Outcome Measures: Trial Recruitment, Binary trial feasibility outcome of whether prospective participants undergoing in-person screening (V0) are found to be fully eligible and ultimately enroll in the study (V1)., Up to 28 days|Trial Completion, Binary trial feasibility outcome of whether enrolled participants complete at least 70% of KAP intervention visits (i.e., Visits #1-10), Up to 35 days|Acceptability Questionnaire, At the end of the KAP intervention (i.e., V10), participants will be administered an 8-item, 5-point-scale questionnaire based off of the Sekhon Theoretical Framework of Acceptability to evaluate eight distinct aspects of the acceptability of the intervention. Higher scores indicate greater levels of intervention acceptability., Up to 35 days
Secondary Outcome Measures: Adverse Events, Information regarding occurrence of adverse events will be captured throughout the study at every visit (i.e., V1-V12). Duration (start and stop dates), severity/grade, outcome, treatment and relation to study drug will be recorded., Up to 119 days|Blood Pressure, During ketamine administration visits (i.e, V4, V6, and V8), blood pressure (in mmHg) will be monitored at serial 15-minute intervals for 60 minutes following ketamine dosing, and subsequently at 30-minute intervals until the session is complete., Up to 28 days|Heart Rate, During ketamine administration visits (i.e, V4, V6, and V8), heart rate (in beats per minute) will be monitored at serial 15-minute intervals for 60 minutes following ketamine dosing, and subsequently at 30-minute intervals until the session is complete., Up to 28 days|Methamphetamine Use by Timeline Follow Back, The TLFB is a semi-structured interview that provides estimates of the daily quantity, frequency, and pattern of substance use during a specified time period. It uses a calendar prompt and number of other memory aids (e.g., holidays, payday, and other personally relevant dates) to facilitate accurate recall of drug use during the target period. The TLFB has shown adequate to excellent reliability and validity over a wide range of research and clinical contexts. Non-study SUD treatment utilization will also be recorded on the TLFB form., Up to 119 days|Methamphetamine Cravings, A Visual Analog Scale (ranging from 0 to 100) will be used to assess participants' overall cravings for methamphetamine at every study visit., Up to 119 days|Amphetamine Cessation Symptom Assessment, The ACSA is a 16-item, 5-point scale (0 = "Not at all" to 4 "Extremely") measuring various aspects of anxiety and mood, fatigue, and craving to measure the severity of amphetamine withdrawal symptoms over the past 24 hours. Higher scores reflect more severe withdrawal symptoms. The ACSA will be administered at all non-ketamine dosing visits (i.e., V1-V3, V5, V7, V9-V12)., Up to 119 days|Methamphetamine Positive Urine Drug Screens, A point-of-care urine drug screen (UDS) will be collected at every study visit (i.e., V1-V12)., Up to 119 days|Methamphetamine Levels in Hair, At baseline (V1), end-of-treatment (V10) and 4- and 12-weeks follow-up (V11 and V12), a 1-cm hair sample will be collected from the back of the scalp to measure cumulative drug levels of methamphetamine over the preceding one month period. Quantification of methamphetamine levels in hair will each require a sample of 50-100 strands, which is roughly the equivalent to the average amount of natural hair loss that occurs on a daily basis., Up to 119 days|Antiretroviral Adherence, If applicable, self-reported days of antiretroviral drug adherence will be measured at baseline (i.e., V1), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12)., Up to 119 days|HIV Risk Behaviors, A set of questions will be used to measure participants' engagement in risk behaviors for HIV acquisition or transmission at baseline (i.e., V1), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12). These will include questions on the number of male and female sex partners; number of sex partners with whom methamphetamine was used; episodes of sex with HIV sero-discordant or unknown partners; and episodes of injection drug use over the past month., Up to 119 days|Depression Symptoms, The Patient Health Questionnaire-9 (PHQ-9) is a validated and widely-used 9-item, 4-point scale (0 = "Not at all" to 3 = "Nearly every day") that assesses depression symptom severity with a 2-week recall period. Higher scores indicate worse depression. It will be administered at baseline (V1), mid-KAP (V7), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12)., Up to 119 days|Anxiety Symptoms, The (GAD-7) is a validated self-report measure for the severity of generalized anxiety disorder (GAD) symptoms. This 7-item, 4-point scale (0 = "Not at all" to "3 = Nearly every day") scale has 2-week recall period. Item scores are summed to produce a total score that can range 0-21, with higher scores indicating greater severity of symptoms of GAD.

It will be administered at baseline (V1), mid-KAP (V7), end-of-treatment (V10), and at 4- and 12-weeks post-KAP (i.e., V11 and V12)., Up to 119 days|PTSD Symptoms, The Abbreviated PCL-C is a shortened version of the PTSD Checklist - Civilian version (PCL-C) developed for use with in primary care or other similar general medical settings. It consists of a 6-item, 5-point scale (0 = "Not at all" to 4 = "Extremely") survey. An individual is considered to have screened positive if the sum of these items is 14 or greater. It will be administered at baseline (V1), following the last ketamine administration (V9), and at 4- and 12-weeks post-KAP (i.e., V11 and V12)., Up to 119 days
Other Outcome Measures: Attachment Insecurity, The Experiences in Close Relationships - Revised Questionnaire (ECR-R) is a 36-item measure of adult attachment style that measures individuals on two 18-item subscales of attachment: Avoidance and Anxiety. Higher scores on each subscale indicate higher levels of avoidance or anxiety in close relationships. Attachment insecurity has been highly correlated with substance use and changes in the severity of attachment insecurity may underly changes in addictive behaviors. The ECR-R will be administered at baseline (V1), following the last ketamine administration (V9), and at 4- and 12-weeks post-KAP (i.e., V11 and V12)., Up to 119 days