Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
ConditionSevere Alcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-64
SponsorBrugmann University Hospital
About this trial
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
Eligibility criteria
Qualifiers
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).
Disqualifiers
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 condition that, in the opinion of the medical investigator (necessarily an M.D.), would pose a risk to the participant's participation in the study.
Other somatic conditions that, in the opinion of the investigator, would pose a risk to the participant's participation in the study.
Trial design
Treatments tested in this trial
- Psilocybin (high dose)
- Active placebo (low dose of psilocybin)
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov