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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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