A 24-Week, Multicentre, Randomised, Double-Blind,... — Clinical Trial Details

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Excluded

Moderate to severe Alcohol Use Disorder (AUD) per DSM-5 using structured clinical interview.
≥6 heavy drinking days (HDDs) in a 4-week period prior to V1 OR average alcohol consumption >40 g/day (males) or >20 g/day (females) for 4 weeks prior to V1; and ≥6 HDDs in 4 weeks prior to V5.
Expressed desire to reduce or stop alcohol consumption.
Able to provide alcohol consumption information for the 4-week period prior to V1.
Willingness to participate in behavioural and medicinal treatments for AUD.
Subjects of childbearing potential must use highly effective contraception for the trial duration (or meet defined sterilisation/post-menopausal criteria).
Generally healthy with no unstable medical conditions as determined by history, exam, labs, ECG, urine analysis and toxicology.

Withdrawal symptoms requiring additional medication (CIWA-Ar score >8).
Diagnosis or family history of schizophrenia or prodromal symptoms, any bipolar disorder, OCD, or other psychotic disorder; recent (within 12 months) major depressive episode (HAM-D >19), TRD, PTSD, panic disorder or eating disorders (exceptions noted for some anxiety disorders).
Current or recent (within 6 weeks prior to V1) treatment with antipsychotic or antidepressant medications that influence serotonin receptors/transporters.
History of hallucinogen use disorder, any use in past year, or >25 lifetime uses.
Currently participating or recently (within 4 weeks) participated in an AUD treatment programme.
Clinically significant untreated or unstable illness including hepatic dysfunction (AST or ALT >3x ULN or total bilirubin >2x ULN), eGFR <50 mL/min/1.73 m2, significant cardiovascular disease, uncontrolled hypertension (systolic >150 mmHg or diastolic >90 mmHg), or ECG abnormalities (e.g., QTcF >450 ms males, >470 ms females; significant ectopy or conduction block).
Allergy or hypersensitivity to psilocybin, other hallucinogens, rescue medications or excipients.

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)