The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in percentage of heavy drinking days
研究概览
简要总结
Note: The trial is only eligible for citizens of Denmark.
The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD).
详细描述
To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a randomised, double-blinded, placebo-controlled 12 weeks clinical trial. 90 patients, aged 20-70 years, diagnosed with alcohol use disorder and treatment seeking will be recruited from the community via advertisement and referrals from general practitioners and hospital units. The psilocybin or placebo is administered within a protocol of psychological support before, during and after the dosing. Outcome assessments will be carried out one, four, eight- and 12 weeks post dosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes include 1) phosphatidyl-ethanol as an objective biomarker for alcohol consumption 2) plasma psilocin, the active metabolite, to establish a possible therapeutic range and 3) the acute subjective drug experience as a possible predictor of treatment outcome. Furthermore, we will investigate the neurobiological underpinnings of the possible treatment effects by use of functional magnetic resonance brain imaging one week post dosing.
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)
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
- •Bodyweight of 50-110 kg
- •AUD according to DSM-5 criteria and alcohol dependence according to ICD-
- •AUD Identification Test (AUDIT) ≥
- •≥ 5 heavy drinking days in the past 28 days prior to inclusion.
排除标准
- •Current or previously diagnosed with any psychotic disorder or bipolar affective disorder.
- •Immediate family member with a diagnosed psychotic disorder.
- •History of delirium tremens or alcohol withdrawal seizures.
- •History of suicide attempt or present suicidal ideation at screening.
- •Withdrawal symptoms at screening (>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43).
- •Present or former severe neurological disease including trauma with loss of consciousness > 30 min.
- •Impaired hepatic function (alanine transaminase >210/135 units/l men/women)
- •Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- •Present or former abnormal QTc (>450/470 ms men/women).
- •Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion.
- •Treatment with any serotonergic medication or drugs within one month prior inclusion.
- •Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score >six/two (men/women) and investigator's clinical evaluation.
- •Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44).
- •Unable to speak or understand Danish.
- •Any other condition that the clinician estimates can interfere with trial participation.
研究组 & 干预措施
Psilocybin-assisted therapy
45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing.
干预措施: Psilocybin (Drug)
Placebo-assisted therapy
45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing.
干预措施: Maltodextrin (Drug)
结局指标
主要结局
Change in percentage of heavy drinking days
时间窗: Baseline to week 12
Heavy drinking is defined as days with five drinks/60 grams of alcohol or more for men, four drinks/48 grams of alcohol or more for women. Data will be collected using the Timeline Followback Method (TLFB) which is a widely used, calendar-based retrospective measure of self-reported use of alcohol. The number of days drinking assessed is 28 days.
次要结局
- Change in Alcohol Use Disorders Identification Test (AUDIT)(Baseline to week 12)
- Change in days of abstinence(Baseline to week 12)
- Change in total alcohol consumption(Baseline to week 12)
- Change in Penn Alcohol Craving Scale (PACS) score(Baseline to week 12)
- Change in Fagerstrom Test for Nicotine Dependence (FTND)(Baseline to week 12)
- Change in Major Depression Inventory (MDI)(Baseline to week 12)
- Change in Short-Form 36 (SF-36)(Baseline to week 12)
- Change in phosphatidyl-ethanol (PEth)(Baseline to week 12)
- Change in Mindful Attention Awareness Scale (MAAS)(Baseline to week 12)
- Change in Acceptance and Action Questionnaire (AAQ)(Baseline to week 12)
- Change in NEO-Personality Inventory (NEO-PI=(Baseline to week 12)
- Persisting Effects Questionnaire (PEQ)(Week 12)
- Subjective effects of psilocybin: Mystical Experience Questionnaire (MEQ)(Completed once the effects are fully subsided or at least 6 hours after dosing)
- Subjective effects of psilocybin: Ego Dissolution Inventory (EDI)(Completed once the effects are fully subsided or at least 6 hours after dosing)
- Change in Alcohol Abstinence Self-efficacy Scale (AASE) score(Baseline to week 12)
- Change in Drug Use Disorders Identification Test (DUDIT)(Baseline to week 12)
- Neuroplasticity and inflammation(Baseline to week 12)
- Subjective effects of psilocybin: Subjective Drug Intensity (SDI)(0-6 hours post dosing)
- Subjective effects of psilocybin: Awe Experience Scale (AWE-S)(Completed once the effects are fully subsided or at least 6 hours after dosing)
- Pharmacokinetics- and dynamics of psilocybin(0 - 6 hours post dosing)
- Subjective effects of psilocybin: 5-Dimensional Altered State of Consciousness scale (5D-ASC)(Completed once the effects are fully subsided or at least 6 hours after dosing)
- Subjective effects of psilocybin: Emotional Breakthrough Inventory (EBI)(Completed once the effects are fully subsided or at least 6 hours after dosing)
- Brain imaging(1 week post dosing)
研究者
Anders Fink-Jensen, MD, DMSci
Professor
Psychiatric Centre Rigshospitalet