A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Frequency of Heavy Drinking Days (HDD)
研究概览
简要总结
To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.
详细描述
New strategies for treating Alcohol Use Disorder (AUD) are urgently needed. Recent evidence has shown promising results for psychedelic-assisted therapies, particularly psilocybin, which has demonstrated efficacy in reducing alcohol consumption and improving psychological well-being. This study aims to evaluate the clinical efficacy and tolerability of psilocybin-assisted therapy compared to a control (niacin) in reducing heavy drinking days (HDD) per week among individuals with AUD.
Primary Objective
To conduct a double-blind, randomised controlled trial with 90 participants diagnosed with Alcohol Use Disorder (AUD). The primary aim is to compare the efficacy of psilocybin-assisted therapy (two sessions of psilocybin, 25 mg per dosing session) versus control (niacin 250mg) and therapy in reducing alcohol consumption, specifically measuring the number of heavy drinking days (HDD) per week.
Secondary Objectives
To compare the efficacy of psilocybin-assisted therapy versus control in improving the characteristics of AUD and addressing common comorbidities associated with AUD, including depression and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double blinded with an additional optional dosing session for open label dosing
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe AUD according to the DSM-5 criteria
- •A desire to reduce or stop drinking
- •Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks/day for men; ≥4 for women) in the past week prior to screening
- •Aged ≥18 years old
- •Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26)
- •Received prior treatment for AUD (not including study interventions)
- •Stable housing within reasonable distance to a clinical site for the duration of the study
- •Able to identify a significant other (such as a family/friend/partner) who could accompany them from clinic/provide transport and/or be contacted by the study team if required
- •Willing to give written informed consent
排除标准
- •a. History of or currently meeting DSM-5 criteria for:
- •Any psychotic disorder
- •Bipolar disorder type 1 or 2
- •Major depression with psychotic features
- •Any personality disorders
- •Post-traumatic stress disorder
- •Hallucinogen persisting perception disorder b. A family history of:
- •Schizophrenia or schizoaffective disorder (first- or second-degree relatives), or
- •Bipolar disorder type 1 (first degree relatives) c. Suicide risk according to clinician judgement (e.g. previous suicide attempt or self-harm in the past 6 months) and responses to Columbia Suicide Severity Rating Scale (C-SSRS) and SCID-5-RV.
- •d. Abnormal and/or serious clinical finding or medical condition that may preclude participation e. Concurrent use of psychotropic medication e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents (e.g. St John's Wort/tryptophan), lithium, anticonvulsants).
- •Use of antidepressants and alcohol pharmacotherapy use considered if assessed by investigator and titrated down with 5 half-lives + 1-week washout f. Use of any medications likely to interact with study medication during the trial (subject to investigator's discretion).
- •Low dose opiates permitted for pain management, however, not the night before or after dosing sessions g. Significant alcohol withdrawal (current CIWA-Ar score ≥10, including history of delirium tremens or alcohol withdrawal seizures).
- •h. Any current substance use disorder (SUD) other than tobacco (e.g. opiates, benzodiazepines, cannabis, psychostimulants, hallucinogens) as per clinician judgement and/or defined by DSM-5 criteria (measured by SCID-RV).
- •i. Substantial lifetime use (>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens, such as psilocybin-containing mushrooms or LSD j. Any alcohol pharmacotherapy (e.g. naltrexone, acamprosate) within the past month.
- •k. Participation in other clinical trials in the previous two months l. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will be performed at baseline and prior to dosing) m. Allergy or hypersensitivity to psilocybin n. Any condition or factor deemed by the study clinician to place the individual at higher risk of an adverse emotional reaction, severe active stressors such as significant legal problems, marital distress or lack of social support.
研究组 & 干预措施
Psilocybin + Therapy
- 12 weekly sessions of psychotherapy for AUD
- 2 dosing sessions - psilocybin 25mg
- Additional open-label dosing session for participants in control arm post-follow up
- 2 integration sessions following each dosing session (additional dosing session for open label dosing)
- 3 post-treatment follow-up sessions
- Total of 13 clinic sessions
干预措施: Psilocybin (Drug)
Niacin + Therapy
- 12 weekly sessions of psychotherapy for AUD
- 2 dosing sessions - niacin 250mg
- 2 integration sessions following each dosing session
- 3 post-treatment follow-up sessions
- Total of 13 clinic sessions
干预措施: Niacin (Drug)
结局指标
主要结局
Frequency of Heavy Drinking Days (HDD)
时间窗: 52 Weeks
Frequency of HDD as measured by the Timeline Follow Back (TLFB) and validated by Phosphatidylethanol (PEth). HDD are defined as ≥4 drinks/day for women and ≥5 drinks/day for men.
次要结局
- Mean alcohol consumption per drinking day(52 Weeks)
- PEth Levels(52 Weeks)
- Changes in Anxiety(52 Weeks)
- Changes in Depression(52 Weeks)
- Changes in Suicidal Ideation(52 Weeks)
- Changes in Quality of Life(52 Weeks)
- Dependence Severity(52 Weeks)
- Alcohol Craving(52 Weeks)
- Markers of Liver Injury(52 Weeks)
- Absence of any HDD(52 Weeks)
- WHO drinking risk level(52 Weeks)