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Psilocybin in alcohol use disorder with comorbid depression - Randomized double-blind controlled pilot study.
EU CTIS ID: 2023-506647-42-00
What this study is testing
To assess the feasibility of a trial comparing psilocybin with very low-dose psilocybin (control) in alcohol use disorder with depressive symptoms.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A patient with a confirmed DSM-5 diagnosis of severe alcohol use disorder.
- BDI II score (Beck Depression Inventory) ≥ 14.
- The last drink must have been consumed between 60 and 14 days before the inclusion visit.
- The patient must have had at least 1 HDD during the last drinking period
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
You likely can't join if
- Schizophrenic disorder, or any history of psychotic disorder as judged by the clinician.
- History of hallucinogen use disorders, any use in the past year or > 25 lifetime uses.
- Dependence on cocaine, psychostimulants, opioids or cannabis (last 12 months)
- Current non-medical use of cocaine, psychostimulants or opioids (past 30 days).
- Severe ECG anomalies
- No access to email.
See the full eligibility criteria
- A patient with a confirmed DSM-5 diagnosis of severe alcohol use disorder.
- BDI II score (Beck Depression Inventory) ≥ 14.
- The last drink must have been consumed between 60 and 14 days before the inclusion visit.
- The patient must have had at least 1 HDD during the last drinking period
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is at least 18 years old
- Schizophrenic disorder, or any history of psychotic disorder as judged by the clinician.
- History of hallucinogen use disorders, any use in the past year or > 25 lifetime uses.
- Dependence on cocaine, psychostimulants, opioids or cannabis (last 12 months)
- Current non-medical use of cocaine, psychostimulants or opioids (past 30 days).
- Severe ECG anomalies
- No access to email.
- Insufficient understanding of French to complete questionnaires.
- past or current manic or hypomanic episode
- Need for antipsychotic treatment that may interfere with psilocybin.
- Suicidal ideation in progress, scripted (as judged by the clinician).
- First-degree relative with a diagnosis of psychotic disorder or type 1 bipolar disorder.
- High risk of negative emotional or behavioral response based on investigator's clinical judgment
- Patients with dementia or severe cognitive impairment
- Score CIWA-R ≥ 8.
- Medical conditions that would prevent safe participation in the trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.