Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behaviour change in addictions such as alcohol dependence. The investigation is a multi-site, double-blind, active-controlled trial (n=95, 47 per group) contrasting the acute and persisting effects of psilocybin (25-30mg/70kg) to those of diphenhydramine (placebo) in the context of outpatient alcoholism treatment.
The active placebo is diphenhydramine (which has some effects but still, participants almost always knew if they were in the active or placebo arm of the study).
The results were favourable: “Percentage of heavy drinking days during the 32-week double-blind period was 9.7% for the psilocybin group and 23.6% for the diphenhydramine group, a mean difference of 13.9%; (95% CI, 3.0-24.7; F1,86 = 6.43; P = .01). Mean daily alcohol consumption (number of standard drinks per day) was also lower in the psilocybin group. There were no serious adverse events among participants who received psilocybin.“
A rationale for the trial was published in November 2022 (three months after the results were published).
Compound Psilocybin
Placebo
Country United States of America
Visit trial
Status
Completed
Results Published
Yes
Start date
01 June 2014
End date
31 July 2021
Chance of happening
100%
Phase
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
95
Sex
All
Age
25- 65
Therapy
Yes
Trial Details
Two to four sites will participate in this study. Aims of the study are 1) to characterize the acute effects of PO psilocybin 25 mg/70 kg, 30 mg/70 kg, and 40 mg/70 kg in alcohol dependent patients; 2) to evaluate the effect of psilocybin treatment on drinking outcomes for 32 weeks after the first administration, relative to diphenhydramine control; 3) to test whether or not characteristics of the drug administration session experiences mediate effects of psilocybin on short-term (1 week) persisting effects and post-session drinking behavior, 4) to evaluate the explanatory value of changes in alcohol craving, self-efficacy, motivation, and other psychological domains in accounting for the observed experimental effect of psilocybin relative to diphenhydramine control, and 5) to evaluate pre-post changes in drinking in participants after they receive psilocybin in the third session. The total duration of psychosocial treatment in the double-blind period will be 12 weeks, and double-blind drug administration sessions will occur after 4 and 8 weeks. In the first psilocybin session, a dose of 25 mg/70 kg will be administered. Depending on the response in the first session, the dose for the second session may be increased to 30 mg/70 kg or 40 mg/70 kg, or held at 25mg/70kg. The dose of diphenhydramine will start at 50 mg, and may be increased to 100 mg or held at 50 mg in the second session, depending on response in the first session. Following completion of the double-blind period (34 weeks after randomization) all participants who meet interim safety criteria will be offered an additional session in which psilocybin will be administered. The drug will be administered during 8-hour sessions in an outpatient setting under close medical and psychiatric monitoring. The drug administration sessions will occur in the context of an extended version of Motivational Enhancement Therapy (Motivational Enhancement and Taking Action, META) with the addition of standardized preparation before and debriefing and follow-up after the psilocybin administration sessions. Extensive screening and baseline assessment will be completed, including thorough safety screening and assessment of participant characteristics that could potentially moderate treatment response. Within-session and short-term persisting effects will be assessed. Drinking outcomes and changes in several potential mediators of treatment effect, including motivation, self-efficacy, craving, depression, anxiety, and spiritual dimensions of the experience, will be measured until 50 weeks after the first drug administration session, for a total of 54 weeks from the initiation of treatment.NCT Number NCT02061293
Sponsors & Collaborators
NYU Langone HealthThis company doesn't have a full profile yet, it is linked to a clinical trial.
Heffter Research Institute
The Heffter Research Institute has been advancing psychedelics (psilocybin) as medicines since 1993.
University of New Mexico
This company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot studyThis reanalysis of a Phase II study (n=11) investigated psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder (AUD). Participants received psilocybin (25mg; n=5) or diphenhydramine (antihistamine; 50mg; n=6). Psilocybin increased activity in the medial and lateral prefrontal cortex and left caudate, while decreasing activity in several other brain regions. These findings suggest enhanced goal-directed action, improved emotional regulation, and diminished craving.
Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder
This double-blind, active placebo-controlled study (n=95) finds that psilocybin (2x, 25-40mg/70kg) significantly reduced the number of heavy drinking days (10% versus 24% in the placebo group) in the 32-week follow-up period. The trial is the first to test psilocybin for alcoholism (alcohol use disorder, AUD) in a double-blind study.