5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Brief description of study

This study will be a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. The current trial will be conducted across three sites with experience in conducting psilocybin research: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University Grossman School of Medicine (NYU). The proposed double-blind study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin; 30 mg in session 1 and either 30 mg or 40 mg in session 2, with sessions 1 week apart (total 2 drug exposures separated by approximately one week); or 2) oral niacin; 150 mg in session 1 and either 150 mg or 200 mg in session 2, with sessions 1 week apart (total 2 drug exposures separated by approximately one week).


Clinical Study Identifier: s22-00503
ClinicalTrials.gov Identifier: NCT05452772
Principal Investigator: Michael P. Bogenschutz.


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