2025-525069-65-00招募中3 期
ERPPAD - Efficacy in Relapse Prevention: Psilocybin in Alcohol use disorder with Depressive symptoms
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 8
- 主要终点
- Time to relapse is defined as the 1st heavy drinking day (HDD), i.e., ≥60g alcohol. Alcohol consumption will be collected every 6 weeks using the Timeline Follow-Back (TLFB) method, with the assistance of either a digital or paper calendar.
研究概览
简要总结
Evaluate the efficacy of administering 2 high doses of 25mg psilocybin 3 weeks apart, compared with administering 2 low doses of 3mg psilocybin 3 weeks apart, on the incidence of relapse in terms of excessive alcohol consumption, in patients with severe AUD and comorbid depression following detoxification, over a period of 6 months.
研究设计
- 分配方式
- Randomized
- 主要目的
- Bras Psilocybine 3mg
- 盲法
- Double (Monitor, Subject, Carer, Investigator, Analyst)
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
- •Confirmed DSM-5 diagnosis of severe AUD.
- •Scale BDI-II ((Beck Depression Inventory) ≥14
- •The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.
- •Patient who has provided informed and voluntary consent.
- •Patient affiliated with or beneficiary of a health insurance plan.
- •Adult patient (≥18 years).
排除标准
- •Any use of classical psychedelic in the last year
- •CIWA-AR > 8
- •Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function¹; coronary artery disease; history of arrhythmia; Abnormal QT interval prolongation (QTc > 470 ms for women and >450 ms for men); heart failure; uncontrolled hypertension (greater than 165/95 mmHg at screening); history of stroke; severe asthma; hyperthyroidism; narrow-angle glaucoma; stenosing gastroduodenal ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy or bladder neck obstruction; uncontrolled type I or type II diabetes, or a history of ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness.
- •Patient participating in an interventional RIPH study, a clinical trial, or a clinical investigation.
- •Patient in an exclusion period determined by another study.
- •Patient under legal protection, guardianship, or curatorship.
- •Patient unable to give informed consent.
- •Patient for whom it is impossible to provide informed information.
- •Participants planning to donate sperm within three months of psilocybin administration
- •Positive pregnancy test at inclusion for participants of childbearing age.
- •Patient who is pregnant, breastfeeding, or wishing to become pregnant during her participation in the study.
- •Other current substance use disorder (except tobacco)
- •Diagnosed schizophrenic or bipolar disorder
- •High emotional lability (clinician-judged)
- •On antipsychotics treatment that may interfere with psilocybin.
- •Need for monoamine oxidase inhibitor (MAOI) treatment, which may interfere with psilocybin.
- •Severe suicidal ideation (high risk on the Columbia scale)
- •1st degree family member with a diagnosed psychotic disorder
- •Severe cognitive impairment (clinician-judged)
研究组 & 干预措施
PSILOCYBINE
Test
干预措施: PSILOCYBINE (Drug)
结局指标
主要结局
Time to relapse is defined as the 1st heavy drinking day (HDD), i.e., ≥60g alcohol. Alcohol consumption will be collected every 6 weeks using the Timeline Follow-Back (TLFB) method, with the assistance of either a digital or paper calendar.
Time to relapse is defined as the 1st heavy drinking day (HDD), i.e., ≥60g alcohol. Alcohol consumption will be collected every 6 weeks using the Timeline Follow-Back (TLFB) method, with the assistance of either a digital or paper calendar.
次要结局
- By group HD and LD will be assessed at weeks 0, 3, 9, 15, 21, 27 : TLFB, CEQ, AQoLS- brief, BDI-II, BAI, DERS, A-RSQ, PCL-5, VPT only week 0, 3 and 28.
- By group HD and LD, the proportion and characteristics of participants requesting a 3rd dose of 25mg psilocybin will be assessed at weeks 27 : TLFB, CEQ, AQoLS- brief, BDI-II, BAI, DERS, A-RSQ, PCL-5, preference for a 3rd dose, Administration of a 3rd dose
- In the subgroups of non-relapsers at 6 months from LD and HD, and in the subgroups “administration 3rd dose” vs “no 3rd dosewill be assessed at weeks 27, 33, 39, 45, 51 : TLFB, CEQ, AQoLS- brief, BDI-II, BAI, DERS, A-RSQ, PCL-5
- In the subgroups of relapsers at 6 months from LD and HD, and in the subgroups “administration 3rd dose” vs “no 3rd dose” will be assessed at weeks 27, 33, 39, 45, 51 : TLFB, CEQ, AQoLS- brief, BDI-II, BAI, DERS, A-RSQ, PCL-5
- In the high dose group: changes from baseline between 6-12 months in the subgroups A3D vs. N3D and in the whole group will be assessed : TLFB, CEQ, AQoLS-brief, BDI-II, BAI, DERS, A-RSQ, PCL-5.
- Potential response factors: ACE, RSQ, MoCA will be assessed only at baseline. PCL-5 will be administered at week 0 and all the follow-up visits. APEQ will be administered prior to the start of each integration session, others patient's caracteristics
- Serious adverse events
- In the groups HD or LD and subgroups relapsers or no-relapsers describe changes of blood samples between baseline and week 28
研究者
leonie gazel
Scientific
Centre Hospitalier Universitaire De Nimes
研究点 (8)
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