Psilocybin in AUD
Trial question
What is the role of psilocybin-assisted psychotherapy in patients with alcohol use disorder?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 95
95 patients (42 female, 53 male).
Inclusion criteria: adult patients 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 alcohol use disorder.
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).
Primary outcome
Rate of heavy drinking days during 32-week period
9.7%
23.6%
23.6 %
17.7 %
11.8 %
5.9 %
0.0 %
Psilocybin
Diphenhydramine
Significant
decrease ▼
NNT = 7
Significant decrease in the rate of heavy drinking days during 32-week period (9.7% vs. 23.6%; AD -13.9%, 95% CI -24.7 to -3).
Secondary outcomes
Borderline significant decrease in the rate 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 (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 adult patients 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 rate 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.
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