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

Sponsor
Centre Hospitalier Universitaire de Nīmes
Study ID
NCT07638553
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin (high dose) — DRUG
    2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
  • Psilocybin (low dose) — DRUG
    2 administrations of low-dose psilocybin (3 mg) 3 weeks apart

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High dose psilocybin
    2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
  • Placebo Comparator: Low-dose psilocybin
    2 administrations of low-dose psilocybin (3 mg) 3 weeks apart

Primary Outcome Measure

Incidence of relapse between groups [ Time Frame: Month 6 ]

Central Contacts

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