5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
Double-blind, randomised, multi-site trial (n=66) comparing two psilocybin sessions (30 mg; second session 30 or 40 mg) versus active placebo niacin (150 mg; second session 150 or 200 mg) plus CBT for smoking cessation.
Details
This multi-site, double-blind randomised trial will recruit 66 daily smokers across Johns Hopkins, UAB, and NYU to test psilocybin plus CBT versus niacin plus CBT for smoking cessation.
Participants receive two dosing sessions one week apart with dose adjustment for session two based on the Mystical Experiences Questionnaire (MEQ30). Primary outcome is biochemically-confirmed 7-day point-prevalence abstinence at 12 months.
Secondary aims include testing cognitive and psychological mediators of treatment response; safety and adverse events are monitored with standard labs, ECG, and clinical assessments.