Pilot Clinical Trial of Ketamine-assisted Psychotherapy for Methamphetamine Use Disorder and HIV Risk Reduction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Trial Recruitment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ketamine-Assisted Psychotherapy
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.
干预措施: Psychotherapy (Behavioral)
Ketamine-Assisted Psychotherapy
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.
干预措施: Ketamine (Drug)
结局指标
主要结局
Trial Recruitment
时间窗: Up to 28 days
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).
Trial Completion
时间窗: Up to 35 days
Binary trial feasibility outcome of whether enrolled participants complete at least 70% of KAP intervention visits (i.e., Visits #1-10)
Acceptability Questionnaire
时间窗: Up to 35 days
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.
次要结局
- Methamphetamine Cravings(Up to 119 days)
- Antiretroviral Adherence(Up to 119 days)
- Adverse Events(Up to 119 days)
- Heart Rate(Up to 28 days)
- Methamphetamine Use by Timeline Follow Back(Up to 119 days)
- Amphetamine Cessation Symptom Assessment(Up to 119 days)
- Blood Pressure(Up to 28 days)
- Methamphetamine Positive Urine Drug Screens(Up to 119 days)
- Methamphetamine Levels in Hair(Up to 119 days)
- Depression Symptoms(Up to 119 days)
- Anxiety Symptoms(Up to 119 days)
研究者
Nicky Mehtani, MD, MPH
Assistant Professor
University of California, San Francisco