Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2KL2TR001870 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| San Francisco Department of Public Health | OTHER_GOV |
| California HIV/AIDS Research Program | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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 psychotherapy for publicly insured patients with moderate-to-severe methamphetamine use disorder (MeUD) who have or are at-risk for HIV. Participants will be administered 3 preparatory psychotherapy visits over the 14 days prior to their first ketamine visit, a psychotherapy integration visit within 1-3 days following each ketamine visit, and a final integration visit about 1 week following their last ketamine visit. This 10-visit Ketamine-Assisted Psychotherapy (KAP) treatment intervention will last about 5 weeks in duration, and 2 follow-up assessment visits will be conducted at 4 and 12 weeks following KAP.
Participants will receive ketamine 0.50 mg/kg IM during their initial dosing visit, and either ketamine 0.50 mg/kg IM or 0.75 mg/kg IM at each subsequent dosing visit, depending on their toleration of prior dose(s).
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Evaluations will be taken at baseline and each of the study visits.
The total duration of subject participation will be up to 119 days-including 5 weeks (i.e., 35 days) for the KAP intervention with follow-up assessment visits at 4 weeks (i.e., 28 days) and 12 weeks (i.e., 84 days) post-intervention.
The total duration of the study is expected to be 12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine-Assisted Psychotherapy | Experimental | Participants will receive 3 administrations of intramuscular (IM) ketamine, dosed approximately once weekly, in combination with 7 psychotherapy visits over a 5-week treatment period. All ketamine dosing and psychotherapy visits will be conducted in-person in a designated therapy room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicky Mehtani, MD MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Department of Public Health | San Francicso | California | 94102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40850924 | Derived | Mehtani NJ, Anderson BT, Alexander I, Hendricks PS, Mitchell JM, Coffin PO, Johnson MO. Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks. BMJ Open. 2025 Aug 24;15(8):e100775. doi: 10.1136/bmjopen-2025-100775. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D000099004 | Chemsex |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D011613 | Psychotherapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Psychotherapy | Behavioral | 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. |
|
|
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 |
| 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 |
| Up to 119 days |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D004191 | Behavioral Disciplines and Activities |