2024-517497-17-01招募中2 期
Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial.
Psykiatrisk Center Kobenhavn1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of heavy drinking days during the last 28 days. A heavy drinking day is defined as a day with an excess intake of 60/48 grams (men/women) of alcohol per day. Data will be registered via TLFB.
研究概览
简要总结
The aim of this research project is to evaluate the effect of a single administration of the 5-HT2A receptor agonist Psilocybin on heavy drinking days from baseline to follow-up after 12 weeks in patients with alcohol use disorder, in a randomized, double-blinded, placebo-controlled clinical trial.
研究设计
- 分配方式
- Randomized
- 主要目的
- Psilocybin for AUD
- 盲法
- Double (Analyst, Monitor, Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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-10
- •Alcohol Use Disorder Identification Test (AUDIT) ≥ 15
- •≥ 5 heavy drinking days defined as alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) in the past 28 days prior to inclusion, measured by TLFB
排除标准
- •Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- •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.
- •Only for patients undergoing brain scans: Contraindications for undergoing an fMRI scan (magnetic implants, pacemaker, claustrophobia etc.)
- •Unable to speak and/or understand Danish.
- •Any condition that the investigator feels would interfere with trial participation.
- •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
- •mpaired renal function (eGFR < 50 ml/min).
结局指标
主要结局
Percentage of heavy drinking days during the last 28 days. A heavy drinking day is defined as a day with an excess intake of 60/48 grams (men/women) of alcohol per day. Data will be registered via TLFB.
Percentage of heavy drinking days during the last 28 days. A heavy drinking day is defined as a day with an excess intake of 60/48 grams (men/women) of alcohol per day. Data will be registered via TLFB.
次要结局
- Total alcohol consumption (gram/day) during the last 28 days. Data will be registered via TLFB.
- Percentage of days without any alcohol consumption during the last 28 days. Data will be registered via TLFB.
- Penn Alcohol Craving Scale (PACS) score.
- Alcohol Use Disorders Identification Test (AUDIT) score.
- Drug Use Disorders Identification Test (DUDIT) score.
- Alcohol Abstinence Self-efficacy (AASE) score.
- Quality of life (SF-36) score.
- Major Depression Inventory (MDI) score.
- Mindful Attention Awareness Scale (MAAS) score.
- NEO Personality Inventory score.
- Acceptance and Action Questionnaire score.
- Fagerström Test for Nicotine Dependence (FTND) score.
- Phosphatidyl-ethanol (PEth).
- Liver parameters gamma-glutamyltransferase (GGT), alanine aminotransferase (ALAT) and mean corpuscular volume (MCV).
- Brain-derived neurotrophic factor (BDNF).
- Markers of inflammation (TNF-a and IL-6).
- Pharmacokinetic properties of plasma psilocin.
- Key phenomena of the acute subjective experience assessed by questionnaires including the Mystical Experience Questionnaire (MEQ30), 11-Dimensional Altered State of Consciousness (11D-ASC)51, Emotional Breakthrough Inventory (EBI), Ego-dissolution Inventory (EDI), The Awe Experience Scale (AES) and the Experience of Music (EM) as well as qualitative analysis of video/audio recordings (before, during and after the psilocybin session).
- Changes in emotional response to music as rated by the Geneva Emotional Music Scale (GEMS) and qualitative descriptions obtained by semi-structured interviews.
- Persisting Effects Questionnaire (PEQ) score
- Post dosing fMRI analysis including differences in functional connectivity during resting state and task-related activity between treatment groups.
研究者
Mathias Ebbesen Jensen
Scientific
Psykiatrisk Center Kobenhavn
研究点 (1)
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