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.
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.
Oral psilocybin two-session regimen with dose adjustment per MEQ30.
Session 1: 30 mg; Session 2: 30 mg or 40 mg based on MEQ30 score
Oral niacin two-session active-placebo regimen with dose adjustment per MEQ30.
Session 1: 150 mg; Session 2: 150 mg or 200 mg based on MEQ30; used as active placebo