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New treatment option for Severe Alcohol Use Disorder
Official title Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06160232
What this study is testing
What is Psilocybin (high dose)?
Psilocybin (high dose) is an investigational medicine, being studied as a potential treatment for severe alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 64
You may be able to join if
- Male or female patients between 21 and 64 years old, with a BMI between 17.5 and 30 kg/m2 who
- Want to stop or decrease their drinking;
- Agree to have all psilocybin-assisted therapy 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...
- Are not currently receiving any pharmacological treatment for sAUD and are willing to engage in all study requirements (including attending all study...
You likely can't join if
- Allergy, hypersensitivity, or other adverse reactions to previous use of psilocybin or other hallucinogens.
- Uncorrected hypertension.
- Cardiovascular diseases, hepatic diseases, gastroenterological diseases, hematologic diseases, renal diseases, endocrine diseases, metabolic...
- Other somatic conditions 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 \ 35 μmol/L, leading to a Child B or C score.
See the full eligibility criteria
- Male or female patients between 21 and 64 years old, with a BMI between 17.5 and 30 kg/m2 who
- Want to stop or decrease their drinking;
- Agree to have all psilocybin-assisted therapy 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...
- Women 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...
- 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.
- 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.
- Allergy, hypersensitivity, or other adverse reactions to previous use of psilocybin or other hallucinogens.
- Uncorrected hypertension.
- Cardiovascular diseases, hepatic diseases, gastroenterological diseases, hematologic diseases, renal diseases, endocrine diseases, metabolic diseases, inflammatory diseases, neurological diseases or any other somatic...
- Other somatic conditions 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 \ 35 μmol/L, leading to a Child B or C score.
- Abnormal ECG. Clinical ECG diagnoses and ECG signs subject to exclusion and needing medical attention: Atrial flutter or fibrillation, AV block 2nd degree or higher, AVNRT (AV-nodal re-entry tachycardia), AVRT...
- Cognitive impairment (Folstein Mini Mental State Exam (Folstein et al., 1975) score \< 26).
- Alcohol withdrawal complication(s), seizure, head injury or stroke within the last 6 months.
- Current active acute stress disorder/post-traumatic stress disorder,
- 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), or other psychotic disorders, or bipolar Type I in first- or second-degree relatives.
- Other substance use disorder (except for caffeine, nicotine, or cannabis) according to DSM-V criteria in the two months preceding inclusion to the study.
- Severe cannabis use disorder according to the DSM-V.
- Need to take medication with significant potential to interact with classical psychedelics (e.g., antidepressants except selective serotonin reuptake inhibitors (SSRIs), antipsychotics, psychostimulants, treatments for...
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful...
- History of hallucinogen use disorder, or \>25 lifetime uses.
- Pregnancy and breastfeeding, at screening visit and till dosing day.
- Known or suspected non-compliance.
- Previous enrollment into the current study.
- Enrollment 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).
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 21 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.