6/29/23, 1:45 AM Psilocybin in AUD Pathway Feedback Search Clinical Topics Home Studies Psilocybin in AUD Psilocybin in AUD Disease Alcohol use disorder Trial question What is the role of psilocybin-assisted psychotherapy in patients with AUD? Study design Multi-center Double blinded RCT Population Characteristics of study participants 44.0% female N = 95 56.0% male 95 patients (42 female, 53 male) Inclusion criteria: adults aged 25-65 years with a DSM-IV diagnosis of alcohol dependence and 4 heavy drinking days during the 30 days prior to screening Key exclusion criteria: major psychiatric and drug use disorders; hallucinogen use; medical conditions contraindicating the study medications; use of exclusionary medications; and current treatment for AUD Interventions N=49 psilocybin (administered at a dose of 25-40 mg/70 kg PO in 2 all-day sessions at week 4 and 8 plus psychotherapy) N=46 diphenhydramine (administered at a dose of 50-100 mg PO in 2 all-day sessions at week 4 and 8 plus psychotherapy) https://web.pathway.md/studies/recXPifTShXs8dsLX 1/2 6/29/23, 1:45 AM Psilocybin in AUD Pathway Primary outcome Percentage of heavy drinking days during 32-week period 23.6 % 23.6 17.7 % 11.8 % 9.7 Significant decrease 5.9 % NNT = 7 0.0 % Psilocybin Diphenhydramine Significant decrease in the percentage of heavy drinking days during 32-week period (9.7% vs. 23.6%; AD -13.9%, 95% CI -24.7 to -3) Secondary outcomes No significant difference in the percentage of drinking days during follow-up (29.4% vs. 42.8%; AD -13.44%, 95% CI -27.05 to 0.18) Significant decrease in drinks per day at follow-up (1.17 vs. 2.26; AD -1.09, 95% CI -1.92 to -0.27) Significant increase in abstinence at weeks 33-36 (47.9% vs. 24.4%; OR 2.84, 95% CI 1.17 to 6.89) Safety outcomes No significant difference in adverse events. Significant difference in headache (43.8% vs. 4.4%). Conclusion In adults aged 25-65 years with a DSM-IV diagnosis of alcohol dependence and 4 heavy drinking days during the 30 days prior to screening, psilocybin was superior to diphenhydramine with respect to the percentage of heavy drinking days during 32-week period. Reference Michael P Bogenschutz, Stephen Ross, Snehal Bhatt et al. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Oct 1;79(10):953-962. Open reference URL https://web.pathway.md/studies/recXPifTShXs8dsLX 2/2