Clinical trial NCT06538285: Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV
Official title: Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Methamphetamine Use Disorder
Keywords: HIV
Methamphetamine withdrawal
Ketamine-assisted therapy
Psychedelic
Sexual Behavior
Methamphetamine
Ketamine-assisted psychotherapy
Chemsex
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Department of Public Health
name: California HIV/AIDS Research Program
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) 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

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 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.

Eligibility 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

Primary outcomes:
measure: Trial Recruitment
timeFrame: Up to 28 days
measure: Trial Completion
timeFrame: Up to 35 days
measure: Acceptability Questionnaire
timeFrame: Up to 35 days
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 119 days
measure: Blood Pressure
timeFrame: Up to 28 days
measure: Heart Rate
timeFrame: Up to 28 days
measure: Methamphetamine Use by Timeline Follow Back
timeFrame: Up to 119 days
measure: Methamphetamine Cravings
timeFrame: Up to 119 days
measure: Amphetamine Cessation Symptom Assessment
timeFrame: Up to 119 days
measure: Methamphetamine Positive Urine Drug Screens
timeFrame: Up to 119 days
measure: Methamphetamine Levels in Hair
timeFrame: Up to 119 days
measure: Antiretroviral Adherence
timeFrame: Up to 119 days
measure: Depression Symptoms
timeFrame: Up to 119 days
measure: Anxiety Symptoms
timeFrame: Up to 119 days
Other outcomes:
measure: Attachment Insecurity
timeFrame: Up to 119 days
Locations:
city: San Francicso
country: United States
facility: San Francisco Department of Public Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nicky Mehtani, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: