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

Recruiting Phase 3 Interventional Study
Alcohol Use Disorder Depressive Sympotoms Psilocybin
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
172 (estimated)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Other
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About This Trial
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 depr…
Trial Locations
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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…
Contacts

Amandine Luquiens

04.66.68.69.98

amandine.luquiens@chu-nimes.fr

CONTACT