The effectiveness of psilocybin is uncertain, despite the fact that traditional psychedelic drugs showed promise in the treatment of alcohol use disorder (AUD). For a study, researchers sought to compare the results seen with active placebo medicine and psychotherapy to those seen with 2 administrations of high-dosage psilocybin to the proportion of heavy drinking days in AUD patients.
Participants in the 12-week manualized psychotherapy program were randomized to take either psilocybin or diphenhydramine during two full days of medication sessions at weeks 4 and 8. A double-blind clinical experiment was conducted. Following the initial dosage of the study drug, outcomes were evaluated throughout the course of a 32-week double-blind trial period. Two university institutions in the US carried out the study. The community was tapped for participants between March 12, 2014, and March 19, 2020. Inclusion criteria comprised adults 25 to 65 years old with a DSM-IV diagnosis of alcohol dependency and at least four days of binge drinking in the 30 days preceding the screening. Major mental and substance use problems, use of hallucinogens, medical issues precluding the study medication, usage of exclusionary drugs, and ongoing AUD treatment were among the exclusion criteria. Psilocybin was used in the study at doses of 25 mg/70 kg (first session) and 25–40 mg/70 kg (second session) compared to diphenhydramine (second session). Cognitive behavioral treatment and motivational improvement therapy were both forms of psychotherapy. The main outcome was the proportion of heavy drinking days, which was determined using a timeline follow-back interview and compared across groups during the 32-week period after the study drug was first administered.
A total of 95 individuals (mean [SD] age, 46 [12] years; 42 [44.2%] female) were randomly assigned to one of 3 groups (49 to psilocybin and 46 to diphenhydramine). American Indian or Alaska Native participants made up 1 participant (1.1%), 3 (3.2%) Asian, 4 (4.2%) Black, 14 (14.7%) Hispanic, and 75 (78.9%) non-Hispanic White participants. In the primary outcome analysis, 93 of the 95 randomly selected patients who had at least one dosage of the study medicine had been administered it. The percentage of days with excessive drinking was 9.7% for the psilocybin group and 23.6% for the diphenhydramine group over the 32-week double-blind phase, yielding a mean difference of 13.9% (95% CI, 3.0-24.7; F1.86 = 6.43; P=.01). The average number of standard drinks consumed daily was lower in the psilocybin group. None of the volunteers who got psilocybin had any severe negative side effects.
In comparison to active placebo and psychotherapy, psilocybin administration in conjunction with the latter resulted in significant reductions in the percentage of heavy drinking days. The findings promoted additional research into psilocybin-assisted AUD therapy.
Reference: jamanetwork.com/journals/jamapsychiatry/fullarticle/2795625
