Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms
ERPPAD
2 other identifiers
interventional
172
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2026
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 5, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
June 10, 2026
June 1, 2026
4 years
June 5, 2026
June 5, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of relapse between groups
Relapse Yes/no, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Month 6
Time to relapse between groups
Days until relapse, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Month 6
Secondary Outcomes (47)
Change in relapse rate between groups
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rate of heavy drinking days between groups
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in total alcohol consumption between groups
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in number of drinking days between groups
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in craving between groups
At weeks 3, 9, 15, 21, 27 compared to baseline
- +42 more secondary outcomes
Study Arms (2)
High dose psilocybin
EXPERIMENTAL2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
Low-dose psilocybin
PLACEBO COMPARATOR2 administrations of low-dose psilocybin (3 mg) 3 weeks apart
Interventions
2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
2 administrations of low-dose psilocybin (3 mg) 3 weeks apart
Eligibility Criteria
You may qualify if:
- Confirmed DSM-5 diagnosis of severe AUD.
- Scale BDI-II ((Beck Depression Inventory) ≥14
- 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
You may not qualify if:
- 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
- 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)
- st degree family member with a diagnosed psychotic disorder
- Severe cognitive impairment (clinician-judged)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Centre Hospitalier de la Côte Basque
Bayonne, France
CHU Besançon
Besançon, France
CHU de Bordeaux
Bordeaux, France
CHU Brest
Brest, France
CH Le Vinatier
Bron, France
CHU de Nantes
Nantes, France
CHU de Nîmes
Nîmes, 30029, France
CHU Saint-Etienne
Saint-Priest, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amandine Luquiens
Centre Hospitalier Universitaire de Nīmes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2026
First Posted
June 10, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
June 10, 2026
Record last verified: 2026-06