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Cited by 23Psychedelics and Drug StudiesSubstance Abuse Treatment and OutcomesPsychotherapy Techniques and Applications

Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial

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O'Donnell, Kelley C., Mennenga, Sarah E., Owens, Lindsey T., Podrebarac, Samantha K., Baron, Tara, Rotrosen, John, Ross, Stephen, Forcehimes, Alyssa A. +1 more·2022·Contemporary Clinical Trials
DOI 10.1016/j.cct.2022.106976
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Abstract

Several lines of evidence suggest that classic psychedelics (5-HT 2A receptor agonists or partial agonists) such as psilocybin might facilitate behavior change in individuals with substance use disorders. We conducted a multi-site, double-blind, randomized controlled trial (RCT) to assess the effects of psilocybin-assisted psychotherapy in alcohol-dependent volunteers. In addition to a structured 12-week psychotherapy platform, participants (n = 96) were randomly assigned (1:1) to receive either oral psilocybin or an active placebo (oral diphenhydramine) in each of two dosing sessions (at weeks 4 and 8). Initial doses were 25 mg/70 kg psilocybin or 50 mg diphenhydramine, which could be increased in the second session depending on initial response. The psychotherapy platform combined evidence-based, manualized therapy for alcohol dependence with a supportive context for the dosing sessions. All participants were followed in the RCT through week 36. At the end of the RCT, participants who still met safety criteria were offered an open-label psilocybin session. Data collected at screening, baseline and throughout the study included: demographics, measures of alcohol use, subjective response to psilocybin and diphenhydramine, and safety measures. The primary outcome was the proportion of heavy drinking days during the 32 weeks after the first dosing session (i.e., between week 4 and week 36). Secondary outcomes included safety, additional measures of drinking (e.g., abstinence, drinking days, etc.), craving, self-efficacy, and acute effects. We will also explore moderators and mediators of the primary outcome. The primary outcomes will be published elsewhere. In this paper, we describe the protocol and rationale for our design decisions.

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  • Two RCTs assessing the effects of PAP in alcohol-dependent volunteers and smokers have been conducted, but results have not been published yet.

    “To address this limitation, two RCTs assessing the effects of PAP in alcoholdependent volunteers 86 and smokers (NCT01943994) have been conducted, albeit results have not been published yet.”

    From The revival of psilocybin between scientific excitement, evidence of efficacy, and real-world challenges (2024) · cites this paper as [86]

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Authors
O'Donnell, K. C., Mennenga, S. E., Owens, L. T., Podrebarac, S. K., Baron, T., Rotrosen, J., Ross, S., Forcehimes, A. A., & Bogenschutz, M. P.
Affiliations
  • New York University (US)
  • University of New Mexico (US)
  • NYU Langone Health (US)
Corresponding author
Bogenschutz, Michael P.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2022-12
Volume
123
Pages
106976
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2022.106976
OpenAlex
W4308040950
Cited by
23
References
39
Citations by year
2026: 2 · 2025: 9 · 2024: 9 · 2023: 3
FWCI
4.79
Type
journal article
Language
en
Open access
Licence
Locations
  • Contemporary Clinical Trials (acceptedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institute on Alcohol Abuse and Alcoholism
  • Heffter Research Institute
  • Pearl Therapeutics
  • Usona Institute
  • National Institutes of Health (00461)
  • National Institute on Drug Abuse
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
psilocybin, alcoholism, psilocybin-assisted therapy, active placebo, diphenhydramine, heavy drinking days, alcohol craving, self-efficacy, acute effects, treatment safety, mediators and moderators
MeSH terms
Alcohol Drinking, Alcoholism, Diphenhydramine, Humans, Psilocybin, Randomized Controlled Trials as Topic, Treatment Outcome

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