drugset / Trial / NCT02061293
A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence
Phase 2
Completed
95 enrolled
NYU Langone Health
Heffter Research Institute · collabUniversity of New Mexico · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.
Timeline
- Start
- 2014-06
- Primary completion
- 2021-07-30
- Completion
- 2021-07-30
Publications
- Pagni BA, Petridis PD, Podrebarac SK, Grinband J, Claus ED, Bogenschutz MP. Psilocybin-induced changes in neural reactivity to alcohol and emotional cues in patients with alcohol use disorder: an fMRI pilot study. Sci Rep. 2024 Feb 7;14(1):3159. doi: 10.1038/s41598-024-52967-8.
- Agin-Liebes G, Nielson EM, Zingman M, Kim K, Haas A, Owens LT, Rogers U, Bogenschutz M. Reports of self-compassion and affect regulation in psilocybin-assisted therapy for alcohol use disorder: An interpretive phenomenological analysis. Psychol Addict Behav. 2024 Feb;38(1):101-113. doi: 10.1037/adb0000935. Epub 2023 Jun 5.
- O'Donnell KC, Mennenga SE, Owens LT, Podrebarac SK, Baron T, Rotrosen J, Ross S, Forcehimes AA, Bogenschutz MP. Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106976. doi: 10.1016/j.cct.2022.106976. Epub 2022 Nov 2.
- Bogenschutz MP, Ross S, Bhatt S, Baron T, Forcehimes AA, Laska E, Mennenga SE, O'Donnell K, Owens LT, Podrebarac S, Rotrosen J, Tonigan JS, Worth L. 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. doi: 10.1001/jamapsychiatry.2022.2096.
- Bogenschutz MP, Forcehimes AA, Pommy JA, Wilcox CE, Barbosa PC, Strassman RJ. Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. J Psychopharmacol. 2015 Mar;29(3):289-99. doi: 10.1177/0269881114565144. Epub 2015 Jan 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diphenhydramine | Unknown | 50 mg | Oral |
| Comparator | Diphenhydramine | Unknown | 100 mg | Oral |
| Subject | Psilocybin | Other / unclassified | 25 mg/kg | Oral |
| Subject | Psilocybin | Other / unclassified | 30 mg/kg | Oral |
| Subject | Psilocybin | Other / unclassified | 40 mg/kg | Oral |