Actively Recruiting
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
Led by Brugmann University Hospital · Updated on 2024-08-07
62
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
CONDITIONS
Official Title
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients between 21 and 64 years old with a BMI between 17.5 and 30 kg/m2
- Want to stop or decrease their drinking
- Agree to have all psilocybin therapy sessions and interviews recorded
- Diagnosed with Severe Alcohol Use Disorder (6 or more DSM-V criteria) confirmed by Mini International Neuropsychiatric Interview
- Not currently receiving pharmacological treatment for severe alcohol use disorder and willing to attend all study sessions and visits
- Women of childbearing potential must have negative pregnancy tests at admission and before psilocybin administration
- Women of childbearing potential must use reliable contraception from inclusion until four weeks post-hospital discharge
- Men with partners of childbearing potential must use condoms from inclusion until four weeks post-hospital discharge
- Good physical health with no unstable medical conditions as determined by exams and lab tests
- Willing to avoid psychoactive substances during study and follow-up
- Able to provide voluntary written informed consent
- Undergoing a 4-week alcohol detoxification program at Brugmann University Hospital
- Remain abstinent from alcohol during detoxification monitored by breathalyzer
- Normal French language comprehension
- Affiliated with the Belgian social security system
You will not qualify if you...
- Allergy or adverse reactions to psilocybin or other hallucinogens
- Uncorrected hypertension
- Cardiovascular, hepatic, gastroenterological, hematologic, renal, endocrine, metabolic, inflammatory, neurological, or other somatic diseases posing risk
- Decompensated hepatic cirrhosis (Child B or C score)
- Serious blood count or chemistry abnormalities leading to Child B or C score
- Abnormal ECG with specific heart conditions requiring medical attention
- Cognitive impairment with Mini Mental State Exam score below 26
- Alcohol withdrawal complications, seizure, head injury, or stroke in last 6 months
- Current active acute stress disorder or post-traumatic stress disorder
- History of schizophrenia spectrum, psychotic disorders, bipolar type I or II, or major depressive episode with psychotic features
- Significant suicide risk
- Family history of schizophrenia spectrum, psychotic disorders, or bipolar type I in first- or second-degree relatives
- Other substance use disorders (except caffeine, nicotine, cannabis) within 2 months before study
- Severe cannabis use disorder
- Need for medications that interact with psychedelics like certain antidepressants, antipsychotics, opioid treatments, or others
- High risk of adverse emotional or behavioral reactions
- History of hallucinogen use disorder or more than 25 lifetime uses
- Pregnancy or breastfeeding
- Known or suspected non-compliance
- Previous enrollment in this study
- Investigator or related persons enrolled
- Legal protection measures preventing consent
- Language barrier preventing protocol participation or assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brugmann University Hospital
Brussels, Belgium
Actively Recruiting
Research Team
L
Laetitia Vanderijst, M.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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