Psilocybin-facilitated Treatment for Cocaine Use
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The difference between the psilocybin and placebo groups in the percentage of days abstinent from cocaine, verified by urine drug screen.
研究概览
简要总结
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement.
MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.
详细描述
Individuals who are eligible to participate and provide informed consent will complete baseline questionnaires and be randomly assigned in a double-blind manner to the Psilocybin or Active Placebo group. The first MRI assessment will take place shortly thereafter using a 3T head-only Magnetic Resonance Imaging and Spectroscopy scanner (Magnetom Allegra, Siemens medial Solutions, Malvern, PA), optimized for neuroimaging applications.
Preparation sessions (see below) and the drug administration session will take place in a room at the Clinical Research Unit designed to be as comfortable, aesthetically pleasing (i.e., living-room like), and safe (e.g., no furniture with sharp corners or glass objects) as possible, with a directly adjacent, private restroom.
All participants will undergo four weekly preparation sessions of approximately 2 hours each. The purpose of these sessions is to: 1) develop strong therapeutic alliance between the participants and the primary therapist (Dr. Hendricks) and secondary therapist; 2) establish comfort and rapport between participants and the remainder of the research team; 3) discuss participants' aspirations with regard to their drug administration experience (e.g., What do participants hope to gain from their experience?); 4) discuss the treatment rationale and putative mechanisms of action of psilocybin; 5) obtain a detailed personal history of the participant, with a focus on those factors contributing to their current difficulties; 6) prepare participants for drug administration, including a detailed account of all potential effects of the drug; 7) discuss all aspects of the drug administration protocol (i.e., logistics and procedures), including plans of action in the event that participants experience acute distress; and 8) administer cognitive-behavioral treatment for cocaine use. Any participant who demonstrates significant anxiety, discomfort, or unease regarding drug administration at the conclusion of the four preparation sessions will be provided up to two additional preparation sessions. If these sessions are unsuccessful at mitigating the participant's anxiety, discomfort, or unease, the participant will be removed from the study.
Approximately one week after their final preparation session, participants will be instructed to eat a low-fat breakfast prior to presenting for their drug administration session at 8:00 am, approximately 1 hour before drug administration. A urine sample will be collected to verify drug-free status and participants will be encouraged to relax and reflect before drug administration. The drug administration session will take place over the course of 8 hours. The primary and secondary therapists will be present with participants throughout this session (at least one individual will always be present with the participant, even during brief intervals when one of the two therapists may be using the restroom). During this time, participants will be encouraged to lie down, use an eye mask to block external visual distraction, and use headphones through which a supportive music program will be played. Participants will be instructed to focus their attention on their inner experiences throughout the session.
Any participant reporting significant distress will be provided reassurance verbally or physically (e.g., with a supportive touch to the hand or shoulder). In the event that psychological distress is insufficiently managed with reassurance alone, medication will be administered under the guidance of the study physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Independent statisticians
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 years of age and older
- •Score of at least 3 on the Severity of Dependence Scale
- •Desire to cease cocaine use as indicated by a goal of complete cocaine abstinence on the Thoughts about Abstinence questionnaire
- •Ability to read/write in English
- •No prior hallucinogen use or it will have been at least 3 years since their last use of a hallucinogen
- •Availability of a friend or family member into whose care the participant can be released following their drug administration session.
- •In good general health as assessed by detailed medical history and physical examination
- •Abstinence from cocaine for at least 7 days prior to experimental drug administration as confirmed via urinalysis and no signs of intoxication on other drugs.
排除标准
- •24 years of age and younger
- •Women who are pregnant or breast feeding
- •Current psychiatric diagnoses other than substance abuse/dependence
- •Current hypertension (exceeding 140 systolic and 90 diastolic at resting as described below)
- •Use of tricyclic antidepressants, lithium, Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors, haloperidol, St. John's Wort, or other antipsychotic medications, mood stabilizers, or medications with serotonin activity
- •History of any psychotic disorders
- •History of bipolar I or II disorder
- •First or second-degree relatives with any psychotic disorders, or bipolar I or II disorders
- •Current suicidal or homicidal ideation
- •Planning to move from the Birmingham area in the next 6 months
- •Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)
研究组 & 干预措施
Diphenhydramine administration
Diphenhydramine will be administered in pill form at a dose of 100 mg. Diphenhydramine will be administered in one session over the course of 8 hours.
干预措施: Diphenhydramine (Drug)
Psilocybin administration
Psilocybin will be administered in pill form at a dose of .36 mg/kg. Psilocybin will be administered in one session over the course of 8 hours.
干预措施: Psilocybin (Drug)
结局指标
主要结局
The difference between the psilocybin and placebo groups in the percentage of days abstinent from cocaine, verified by urine drug screen.
时间窗: From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.
Percentage of days abstinent from cocaine among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
The difference between the psilocybin and placebo groups in sustained/complete abstinence from cocaine, verified by urine drug screen.
时间窗: From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.
Sustained/complete abstinence from cocaine among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
The difference between the psilocybin and placebo groups in time to cocaine lapse.
时间窗: From the psilocybin or placebo administration session to 24 weeks after end-of-treatment.
Number of days to first use of cocaine after the drug administration session among subjects in each of the arms (subjects receiving psilocybin and subjects receiving placebo) assessed with the Timeline Followback Interview and with biochemically verified cocaine presence as assessed via a urine drug screen.
次要结局
- The difference between the psilocybin and placebo groups in the severity of cocaine withdrawal symptoms.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in cocaine craving.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in the severity of cocaine dependence.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in depression, anxiety, and stress.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in satisfaction with life.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in situational cocaine abstinence self-efficacy.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in motivation to quit/remain abstinent, confidence in the ability to quit/remain abstinent, and perceived difficulty quitting/remaining abstinent.(Within 48 hours after psilocybin or placebo administration, at end-of-treatment (approximately 4 weeks after psilocybin or placebo administration in most participants), at 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in the percentage of days abstinent from alcohol.(From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in the percentage of days abstinent from tobacco.(From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in income, employment, and living situation.(At 12 weeks after end-of-treatment, and at 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in the percentage of days abstinent from heavy alcohol use.(From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.)
- The difference between the psilocybin and placebo groups in the percentage of days abstinent from cannabis.(From the psilocybin or placebo administration session to end-of-treatment (approximately 4 weeks in most participants), from end-of-treatment to 12 weeks after end-of-treatment, and from 12 weeks after end-of-treatment to 24 weeks after end-of-treatment.)
研究者
Peter Hendricks
University Professor
University of Alabama at Birmingham