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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Psilocybin (high dose)
DrugPsilocybin-assisted therapy
Active placebo (low dose of psilocybin)
DrugPlacebo-assisted therapy
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: high dose psilocybinExperimental treatment 1 intervention
Group B: low dose psilocybin (active placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary clinical outcome: change in percentage of heavy drinking days
The primary clinical outcome is the difference between the two treatment arms in terms of change from baseline (going back 8 weeks pre-enrolment) to 4 weeks post-hospital discharge (week 1 to 4 post-discharge) in the percentage of heavy drinking days. A heavy drinking day is defined as a day with ≥ 5 standard drinks/60g of alcohol for males, and ≥ 4 standard drinks/48g of alcohol for females. Alcohol consumption will be measured using the Timeline Follow-Back method (Sobell \& Sobell, 1992), a semi-structured interview that provides estimates of the daily quantity, frequency, and pattern of alcohol (and other drugs) use during a set time period. The method has demonstrated adequate to excellent reliability and validity over a wide range of studies and clinical contexts (Carey, 1997; Sobell et al., 1996).
Time frame
Baseline (going back to 8 weeks pre-enrolment) to 4 weeks post-hospital discharge2
Feasibility: recruitment and retention rate
Recruitment and retention rate will be recorded and reported. A consort diagram displaying participant retention at each phase of the recruitment, screening and data collection process will be presented. We will report the numbers of individuals provided with participant information sheets who subsequently decided not to participate in the trial, number that underwent screening and number of drop-outs. For full transparency on inclusivity, information on the demographics and reason for exclusion will be reported from the screening dataset.
Time frame
Recruitment rate: at screening and enrolment. Retention rate: at each study visit3
Safety: adverse events
Adverse events will be systematically assessed at each study visit and follow-ups. Adverse events summary tables will display the total number of participants reporting an adverse event and the percentage of participants (%) with an adverse event.
Time frame
At each study visitSecondary outcomes
1
Percent Heavy Drinking Days
Alcohol consumption as measured with the Timeline Follow Back Method
Time frame
from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 6 months post-hospital discharge (week 5 to 26 weeks)2
Drinks per Day
Alcohol consumption as measured with the Timeline Follow Back Method
Time frame
from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 4 weeks and 6 months post-hospital discharge3
Percent Days Abstinent
Alcohol consumption as measured with the Timeline Follow Back Method
Time frame
from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 4 weeks and 6 months post-hospital discharge4
EEG-derived auditory long-term potentiation
Index of cortical neuroplasticity
Time frame
Neuroplasticity EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)Sponsors and contacts
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Source ClinicalTrials.gov