Authorised Therapeutic confirmatory (Phase III) Alcohol use disorder

ERPPAD - Efficacy in Relapse Prevention: Psilocybin in Alcohol use disorder with Depressive symptoms

EU CTIS ID: 2025-525069-65-00

What this study is testing

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.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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).

You likely can't join if

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.

See the full eligibility criteria

Who can join

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).

What rules you out

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)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.