Psychedelic therapy aims to break the relapse cycle in alcoholism and depression
NCT ID NCT07638553
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 4 times
Summary
This phase 3 trial investigates whether high-dose psilocybin, given alongside psychotherapy, can prevent relapse in people with severe alcohol use disorder who also have depressive symptoms. Participants receive either a high dose (25 mg) or a low dose (3 mg) of psilocybin in two sessions three weeks apart. The study measures relapse rates and time to relapse over six months, building on promising pilot results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- psilocybin
- What this could lead to
- If successful, this could offer a new, fast-acting treatment option for people with both alcohol use disorder and depression, helping them stay sober longer.
- What could go wrong
- This is a phase 3 trial, but results may not apply to everyone. Psilocybin can cause intense psychological effects, and the therapy requires careful supervision.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 172 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Jun 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alcohol use disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
8 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
CH Le Vinatier
NOT_YET_RECRUITINGBron, France
-
CHU Besançon
NOT_YET_RECRUITINGBesançon, France
-
CHU Brest
NOT_YET_RECRUITINGBrest, France
-
CHU Saint-Etienne
NOT_YET_RECRUITINGSaint-Priest, France
-
CHU de Bordeaux
NOT_YET_RECRUITINGBordeaux, France
-
CHU de Nantes
NOT_YET_RECRUITINGNantes, France
-
CHU de Nîmes
RECRUITINGNîmes, 30029, France
-
Centre Hospitalier de la Côte Basque
NOT_YET_RECRUITINGBayonne, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can Brain-Training games rewire the mind to fight alcohol addiction?
- Can a Stress-Hormone blocker take the edge off alcohol?
- Brain training by feedback: a new angle on depression
- Can MDMA plus therapy help veterans fight both PTSD and alcohol addiction?
- Brain scans probe opioid receptor imbalance in alcohol use disorder
- Spinal taps open a window on alcohol use disorder