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Can a single dose of psilocybin reduce alcohol intake in patients with alcohol use disorder?
EU CTIS ID: 2024-517497-17-01
What this study is testing
The aim of this research project is to evaluate the effect of a single administration of the 5-HT2A receptor agonist Psilocybin on heavy drinking days from baseline to follow-up after 12 weeks in patients with alcohol use disorder, in a randomized, double-blinded, placebo-controlled clinical trial.
- Phase I and Phase II (Integrated)- Other
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
- Age of 20-70 years (both included)
- Body weight of 60-95 kg (both included)
- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10
- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15
- ≥ 5 heavy drinking days defined as alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) in the past 28 days prior to inclusion, measured by TLFB
You likely can't join if
- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
- Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
- Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
- Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective.
See the full eligibility criteria
- Age of 20-70 years (both included)
- Body weight of 60-95 kg (both included)
- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10
- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15
- ≥ 5 heavy drinking days defined as alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) in the past 28 days prior to inclusion, measured by TLFB
- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
- Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
- Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
- Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective.
- Hypersensitivity to the active substance or to any of the excipients.
- Only for patients undergoing brain scans: Contraindications for undergoing an fMRI scan (magnetic implants, pacemaker, claustrophobia etc.)
- Unable to speak and/or understand Danish.
- Any condition that the investigator feels would interfere with trial participation.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation.
- Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
- Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
- Impaired hepatic function (liver transaminases >3 times upper normal limit).
- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
- Abnormal electrocardiogram
- mpaired renal function (eGFR < 50 ml/min).
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.