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Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder.
EU CTIS ID: 2024-518061-10-00
What this study is testing
Primary clinical objective: The primary clinical objective is to compare the effect of a high dose of psilocybin (30 mg) relative to an active placebo (psilocybin, 5 mg) in conjunction with supportive psychotherapy provided during the course of a 28-day inpatient alcohol rehabilitation program, on alcohol consumption in terms of changes in the percentage of heavy drinking days from pre-hospitalization (up to 8 weeks pre-hospitalization) to 4 weeks post-hospital discharge (week 1 to 4) in patients with severe Alcohol Use Disorder (sAUD). Primary Feasibility Objective: To assess the feasibility and safety of implementing psilocybin-assisted therapy as a complementary intervention during inpatient rehabilitation for sAUD, in terms of recruitment and retention rates (exploratory) as well as safety.
- 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
- Male or female patients between 21 and 70 years old, with a minimum BMI of 17.5 kg/m2 who want to stop or decrease their drinking;
- Ability to provide voluntary written informed consent after receiving written information about the study protocol
- Undergoing a 4-week alcohol detoxification program at the Brugmann University Hospital
- Remaining abstinent from alcohol during the detoxification program (abstinence will be monitored using a breathalyzer during unannounced checks)
- Normal level of language comprehension (French)
- Affiliation to the Belgian social security system.
You likely can't join if
- - Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin or other hallucinogens
- Current active ASD/PTSD
- Lifetime history of schizophrenia spectrum disorders (schizophrenia, schizoaffective disorder, unspecified), other psychotic disorders or bipolar spectrum disorders (Type I, II, unspecified).
- Lifetime history of major depressive episode with psychotic features.
- Significant risk of suicide according to clinician assessment.
- Family history of schizophrenia spectrum disorders (schizophrenia, schizoaffective disorder, unspecified), other psychotic disorders or bipolar
See the full eligibility criteria
Who can join
- Male or female patients between 21 and 70 years old, with a minimum BMI of 17.5 kg/m2 who want to stop or decrease their drinking;
- Ability to provide voluntary written informed consent after receiving written information about the study protocol
- Undergoing a 4-week alcohol detoxification program at the Brugmann University Hospital
- Remaining abstinent from alcohol during the detoxification program (abstinence will be monitored using a breathalyzer during unannounced checks)
- Normal level of language comprehension (French)
- Affiliation to the Belgian social security system.
- Agree to have all PATh sessions (preparation, administration, integration) and semi-structured interviews recorded
- Have a diagnosis of Severe Alcohol Use Disorder (sAUD), according to the DSM-V (6 criteria or more), ascertained using the Mini International Neuropsychiatric Interview (M.I.N.I 7.0.2).
- Are not currently receiving any pharmacological treatment for sAUD and are willing to engage in all study requirements (including attending all study visits, preparatory sessions, integration sessions, follow-up sessions, and completing all study evaluations).
- Female participants of childbearing potential must have a negative serum pregnancy test at admission (day 1 +/-2) and a negative urine pregnancy test the day before psilocybin administration (day 19 +/-2).
- Women of childbearing potential must be using an effective, established method of contraception from inclusion until four weeks post-hospital discharge (5 weeks post-psilocybin administration). The following methods of contraception, if used properly and used for the duration of the study, are considered reliable: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - oral, - intravaginal, - transdermal; progestogenonly hormonal contraception associated with inhibition of ovulation: - oral, - injectable, - implantable; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner (provided that partner is the sole sexual partner of the woman of child-bearing potential trial participant and that the vasectomised partner has received medical assessment of the surgical success; sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). Note: female participants who are permanently sterilized (eg hysterectomy and/or bilateral salpingectomy) or post-menopausal (at least 48 consecutive weeks without menstruation) are not considered as being of childbearing potential
- Men with a woman of childbearing potential partner should use a condom from inclusion until four weeks post-hospital discharge (5 weeks post-psilocybin administration).
- Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
- Willing to refrain from consuming psychoactive substances after enrolling in the study and during follow-up
What rules you out
- - Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin or other hallucinogens
- Current active ASD/PTSD
- Lifetime history of schizophrenia spectrum disorders (schizophrenia, schizoaffective disorder, unspecified), other psychotic disorders or bipolar spectrum disorders (Type I, II, unspecified).
- Lifetime history of major depressive episode with psychotic features.
- Significant risk of suicide according to clinician assessment.
- Family history of schizophrenia spectrum disorders (schizophrenia, schizoaffective disorder, unspecified), other psychotic disorders or bipolar
- Type I in first- or second-degree relatives. Other substance use disorder (except for caffeine or nicotine) according to DSM V criteria in the two months preceding inclusion to the study.
- Need to take medication with significant potential to interact with classical psychedelics (e.g., antidepressants except SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), antipsychotics, psychostimulants, treatments for alcohol addiction as naltrexone or acamprosate or baclofen, opioid agonist treatment as buprenorphine or methadone, lithium, anticonvulsants, other dopaminergic or serotonergic agents)
- History of hallucinogen use disorder, any use in the past 1 year, or >25 lifetime uses.
- Pregnancy and breastfeeding, at screening visit and till dosing day.
- Known or suspected non-compliance
- Uncorrected hypertension
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- Patient subject to a legal protection measure (guardianship, curatorship or safeguard of justice), patient unable to express consent and not subject to a protection measure
- Patients with language barrier (unable to follow the protocol or respond to clinical assessments).
- Cardiovascular diseases, hepatic diseases, gastroenterological diseases, hematologic diseases, renal diseases, endocrine diseases, metabolic diseases, inflammatory diseases, neurological diseases or any other somatic condition that, in the opinion of the medical investigator (necessarily an MD), would pose a risk to the participant's participation in the study.
- Other somatic condition that, in the opinion of the investigator, would pose a risk to the participant's participation in the study
- Decompensated hepatic cirrhosis, defined by Child B or C score
- Serious abnormalities of complete blood count or chemistries, biological abnormalities including TP < 50%, albumin < 35 g/L, total bilirubin > 35 μmol/L, leading to a Child B or C score
- Abnormal electrocardiogram
- Cognitive impairment (Folstein Mini Mental State Exam (Folstein et al., 1975) score < 26).
- Alcohol withdrawal complication(s), head injury or stroke within the last 6 months
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, 65+ years, 18-64 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.