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RecruitingPhase 3

Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms

NCT07638553 · ERPPAD · Centre Hospitalier Universitaire de Nīmes

Recruiting
Status
Accepting participants
Phase 3
Phase
172
Target enrolment
8
Study sites
Outside the US

What it is testing

Summary

Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants. The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \[0.16-1.65\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence of relapse between groups

    Measured over Month 6

  • Time to relapse between groups

    Measured over Month 6

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * 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. * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: * The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study * The subject refuses to sign the consent * It is impossible to give the subject informed information * The patient is under safeguard of justice or state guardianship * Patient unable to give informed consent. * 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 participation in the study. * Any use of classical psychedelic in the last year * 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) * CIWA-AR \> 8 * Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function; 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.

Where

8 study sites

FacilityCityRegionCountry
Centre Hospitalier de la Côte BasqueBayonneFrance
CHU BesançonBesançonFrance
CHU de BordeauxBordeauxFrance
CHU BrestBrestFrance
CH Le VinatierBronFrance
CHU de NantesNantesFrance
CHU de NîmesNîmesFrance
CHU Saint-EtienneSaint-PriestFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07638553 on ClinicalTrials.gov →

Last updated in the registry 2026-07-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits