Psilocybin or Nicotine Patch for Smoking Cessation: A Pilot Randomized Clinical Trial

A single psilocybin session combined with cognitive behavioral therapy produced substantially higher long-term tobacco abstinence rates than the FDA-approved nicotine patch with the same therapy. Among 82 treatment-resistant smokers, biochemically verified prolonged abstinence at six months was 40.5% for psilocybin versus 10% for the nicotine patch, a sixfold increase in odds. Point-prevalence abstinence was 52.4% for psilocybin versus 25.0% for the patch. No serious adverse events were attributed to either treatment. These results suggest psilocybin holds robust promise for smoking cessation, with abstinence rates considerably exceeding those of typical treatments.

Study at a glance

Abstract

BACKGROUND. Annual tobacco-related deaths are estimated at 480,000 in the US and 8 million worldwide, dwarfing mortality for all other drugs of abuse. Most smoking cessation interventions result in modest long-term success rates. A pilot study in 15 treatment-resistant smokers found psilocybin with cognitive behavioral therapy resulted in 80% point-prevalence abstinence rates at 6 months. METHODS. This comparative efficacy study randomized 82 cigarette smokers to receive either 30 mg/70 kg psilocybin (n=42) or FDA-approved nicotine patch treatment (n=40). Both groups received a 13-week manualized cognitive behavioral therapy (CBT) program for smoking cessation. Introspective psilocybin sessions occurred on the target-quit-date. Biochemically verified prolonged smoking abstinence (primary) and point-prevalence abstinence (secondary) at 6 months were compared between groups using intent-to-treat analysis. RESULTS. Participants on average were 48 years old, smoked 16 cigarettes daily, and had 8 previous unsuccessful quit attempts. The sample was 40% female and 89% White. Demographics did not differ significantly between groups. At 6-month follow-up, prolonged abstinence rates were 40.5% for psilocybin vs 10% for nicotine patch (odds ratio [OR], 6.1 [95% CI, 2.0 - 23.3], p = .003), and point-prevalence abstinence rates were 52.4% for psilocybin vs 25.0% for nicotine patch (OR=3.3 [95% CI, 1.3 – 8.7], p = .013). No serious adverse events were attributed to psilocybin or nicotine patch. CONCLUSIONS. One psilocybin session, compared to nicotine patch treatment, with manualized CBT, significantly and substantially increased long-term tobacco abstinence. Abstinence rates were considerably higher than typical smoking cessation treatments, indicating robust promise of psilocybin for tobacco smoking cessation. TRIAL REGISTRATION. ClinicalTrials.gov Identifier: NCT01943994