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Michael P. Bogenschutz, Stephen Ross, Snehal R. Bhatt, Tara Baron, Alyssa A. Forcehimes, EUGENE M. LASKA, Sarah E. Mennenga, Kelley C. O’Donnell, Lindsey T. Owens, Samantha K. Podrebarac and 3 more
Importance: Although classic psychedelic medications have shown promise in the treatment of alcohol use disorder (AUD), the efficacy of psilocybin remains unknown. Objective: To evaluate whether 2 administrations of high-dose psilocybin improve the percentage of heavy drinking days in patients with AUD undergoing psychotherapy relative to outcomes observed with active placebo medication and psychotherapy. Design, Setting, and Participants: In this double-blind randomized clinical trial, participants were offered 12 weeks of manualized psychotherapy and were randomly assigned to receive psilocybin vs diphenhydramine during 2 day-long medication sessions at weeks 4 and 8. Outcomes were assessed over the 32-week double-blind period following the first dose of study medication. The study was conducted at 2 academic centers in the US. Participants were recruited from the community between March 12, 2014, and March 19, 2020. Adults aged 25 to 65 years with a DSM-IV diagnosis of alcohol dependence and at least 4 heavy drinking days during the 30 days prior to screening were included. Exclusion criteria included major psychiatric and drug use disorders, hallucinogen use, medical conditions that contraindicated the study medications, use of exclusionary medications, and current treatment for AUD. Interventions: Study medications were psilocybin, 25 mg/70 kg, vs diphenhydramine, 50 mg (first session), and psilocybin, 25-40 mg/70 kg, vs diphenhydramine, 50-100 mg (second session). Psychotherapy included motivational enhancement therapy and cognitive behavioral therapy. Main Outcomes and Measures: The primary outcome was percentage of heavy drinking days, assessed using a timeline followback interview, contrasted between groups over the 32-week period following the first administration of study medication using multivariate repeated-measures analysis of variance. Results: A total of 95 participants (mean [SD] age, 46 [12] years; 42 [44.2%] female) were randomized (49 to psilocybin and 46 to diphenhydramine). One participant (1.1%) was American Indian/Alaska Native, 3 (3.2%) were Asian, 4 (4.2%) were Black, 14 (14.7%) were Hispanic, and 75 (78.9%) were non-Hispanic White. Of the 95 randomized participants, 93 received at least 1 dose of study medication and were included in the primary outcome analysis. 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. Conclusions and Relevance: Psilocybin administered in combination with psychotherapy produced robust decreases in percentage of heavy drinking days over and above those produced by active placebo and psychotherapy. These results provide support for further study of psilocybin-assisted treatment for AUD. Trial Registration: ClinicalTrials.gov Identifier: NCT02061293.
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Bogenschutz, M. P., Ross, S., Bhatt, S. R., Baron, T., Forcehimes, A. A., LASKA, E. M., Mennenga, S. E., O’Donnell, K. C., Owens, L. T., Podrebarac, S. K., Rotrosen, J., Tonigan, J. S., & Worth, L. (2022). Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder. JAMA Psychiatry, 79(10), 953. https://doi.org/10.1001/jamapsychiatry.2022.2096
Bogenschutz, Michael P., et al. "Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder." JAMA Psychiatry, vol. 79, no. 10, 2022, pp. 953, https://doi.org/10.1001/jamapsychiatry.2022.2096.
Bogenschutz, Michael P., Stephen Ross, Snehal R. Bhatt, Tara Baron, Alyssa A. Forcehimes, EUGENE M. LASKA, Sarah E. Mennenga, et al. "Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder." JAMA Psychiatry 79, no. 10 (2022): 953. https://doi.org/10.1001/jamapsychiatry.2022.2096.
Bogenschutz M. P., Ross S., Bhatt S. R. [и др.] Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder // JAMA Psychiatry. — 2022. — Vol. 79, № 10. — P. 953. — URL: https://doi.org/10.1001/jamapsychiatry.2022.2096
@article{bogenschutz2022percentage,
title = {{Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder}},
author = {Michael P. Bogenschutz and Stephen Ross and Snehal R. Bhatt and Tara Baron and Alyssa A. Forcehimes and EUGENE M. LASKA and Sarah E. Mennenga and Kelley C. O’Donnell and Lindsey T. Owens and Samantha K. Podrebarac and John Rotrosen and J. Scott Tonigan and Lindsay Worth},
journal = {JAMA Psychiatry},
year = {2022},
volume = {79},
number = {10},
pages = {953},
doi = {10.1001/jamapsychiatry.2022.2096},
url = {https://doi.org/10.1001/jamapsychiatry.2022.2096}
}TY - JOUR AU - Bogenschutz, Michael P. AU - Ross, Stephen AU - Bhatt, Snehal R. AU - Baron, Tara AU - Forcehimes, Alyssa A. AU - LASKA, EUGENE M. AU - Mennenga, Sarah E. AU - O’Donnell, Kelley C. AU - Owens, Lindsey T. AU - Podrebarac, Samantha K. AU - Rotrosen, John AU - Tonigan, J. Scott AU - Worth, Lindsay TI - Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder JO - JAMA Psychiatry VL - 79 IS - 10 SP - 953 PY - 2022 DA - 2022/08/24 DO - 10.1001/jamapsychiatry.2022.2096 UR - https://doi.org/10.1001/jamapsychiatry.2022.2096 ER -
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