Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder
研究概览
简要总结
The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD.
详细描述
The investigators will evaluate the feasibility and safety of administering psilocybin to 10 patients diagnosed with AUD. Following informed consent, patients will be screened for eligibility as per in- and exclusion criteria and baseline values will be recorded as per outcome measures. All patients will receive a single administration of 25 mg of psilocybin. As per safety guidelines patients will be monitored the entire dosing session by study staff familiar with the psychedelic effects of psilocybin. In addition, the patients will meet before and after the dosing session with a psychologist connected to the study for preparation and post-session debriefing, respectively. During dosing session, the investigators will collect blood plasma psilocin levels in order to establish pharmacokinetics and an estimated brain 5-HT2AR occupancy. When the effects of psilocybin subside, the investigators will ask the patients to fill out questionnaires encapsulating the psychedelic experience. One week after drug administration the patients are required to meet for an end-of-study assessment of outcome measures including adverse events.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20-70 years (both included).
- •Body weight of 60-95 kg (both included).
- •Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-
- •Alcohol Use Disorder Identification Test (AUDIT) ≥
- •≥ 5 heavy drinking days.
排除标准
- •Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- •History of delirium tremens or alcohol withdrawal seizures.
- •History of suicide attempt or present suicidal ideation.
- •Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
- •Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
- •Impaired hepatic function (liver transaminases > 3 times upper normal limit).
- •Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
- •Abnormal electrocardiogram
- •Impaired renal function (eGFR < 50 ml/min).
- •Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- •Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
- •Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
- •Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
- •Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective
- •Hypersensitivity to the active substance or to any of the excipients.
- •Unable to speak and/or understand Danish.
- •Any condition that the investigator feels would interfere with trial participation.
研究组 & 干预措施
Psilocybin
10 patients will receive a single administration of psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder
时间窗: 12 week after drug administration
Assessment of the incidence and severity of expected and unexpected adverse events
次要结局
- Pharmacokinetic parameter of psilocin: Cmax(From drug administration and 360 minutes after.)
- Subjective effects of psilocybin: Mystical Experience(8 hours after drug administration)
- Pharmacodynamics of cardiovascular measures(From drug administration to 360 minutes after)
- Feasibility: Proportion of participants who complete(1 week after drug administration)
- Pharmacokinetic parameter of cytokines(From drug administration to 360 minutes after and 1 week after)
- Subjective effects of psilocybin: Intensity(From drug administration to 8 hours after)
- Subjective effects of psilocybin: Altered States of Consciousness(8 hours after drug administration)
- Change in heavy drinking days(Baseline, 4, 12 and 52 weeks after drug administration)
- Change in drinking days(Baseline, 4, 12 and 52 weeks after drug administration)
- Persisting Effects(4, 12 and 52 weeks after drug administration)
- Pharmacokinetic parameter of psilocin: Tmax(From drug administration to 360 minutes after.)
- Pharmacokinetic parameter of psilocin: AUC(From drug administration to 360 minutes after.)
- Pharmacokinetic parameter of brain-derived neurotropic factor(From drug administration to 360 minutes after and 1 week after)
- Change in alcohol use(Baseline, 12 and 52 week after drug administration)
- Change in craving(Baseline, 1 week, 4 week, 12 and 52 week after drug administration)
- Change in self-efficacy(Baseline, 1 week, 4 week, 12 and 52 week after drug administration)
- Subjective effects of psilocybin: Awe Experience(8 hours after drug administration)
- Subjective effects of psilocybin: Ego Dissolution(8 hours after drug administration)
- Change in mindfulness(Baseline, 1 week, 4 week, 12 and 52 week after drug administration)
- Change in depressive symptoms(Baseline, 1 week, 4 week, 12 and 52 week after drug administration)
- Change in drinks per day(Baseline, 4, 12 and 52 weeks after drug administration)
- Change in psychological flexibility(Baseline, 1 week, 4 week, 12 and 52 week after drug administration)
- Expectancy to treatment(Baseline)
- Change in personality traits(Baseline and Week 12 after drug administration)
研究者
Anders Fink-Jensen, MD, DMSci
Professor
Psychiatric Centre Rigshospitalet