• Psilocybin in Alcohol Use Disorder With Comorbid Depression

  NCT06235411

  CompletedInterventionalNot ApplicableUpdated Mar 19, 2025
• Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder

  NCT04620759

  Active, not recruitingInterventionalPhase 2Updated Mar 13, 2026
• Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

  NCT06349083

  RecruitingInterventionalPhase 2Updated Aug 12, 2026
• Psilocybin-assisted Therapy for Alcohol Use Disorder

  NCT06444243

  Unknown statusInterventionalPhase 2Updated Jun 10, 2024
• Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

  NCT05646303

  Unknown statusInterventionalPhase 2Updated Aug 15, 2024
• Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence

  NCT01534494

  CompletedInterventionalPhase 2Updated Sep 26, 2023

ClinicalTrials.gov ID

NCT07638553

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

172Estimated

Last Update Posted

Jul 1, 2026Actual

Start Date

Jun 30, 2026Actual

Primary Completion Date

Jun 2030Estimated

Completion Date

Jun 2030Estimated

Official Title

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

Brief 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.

• Alcohol Use Disorder
• Depressive Sympotoms
• Psilocybin

• Psilocybin (high dose)
• Psilocybin (low dose)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Centre Hospitalier Universitaire de NīmesOTHER

morgane.guillou@chu-brest.fr02 98 34 23 48