Psilocybin or Nicotine Patch for Smoking Cessation: A Pilot Randomized Clinical Trial
Mendeley Data February 2, 2026 DOI: 10.17632/psdmryynyw.3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Pilot study Peer reviewed |
|---|---|
| Sample size | 82 |
| Population | Cigarette smokers averaging 48 years old, 16 cigarettes per day, and 8 previous unsuccessful quit attempts |
| Interventions | Psilocybin Nicotine patch |
| Dose | 30 mg/70 kg |
| Duration | 13-week intervention, 6-month follow-up |
| Topics | Psilocybin |
| Keywords | Nicotine patch Abstinence Smoking cessation Randomized controlled trial Hallucinogen Adverse effect Anesthesia |
| Registration | NCT01943994 |
| Key findings | Psilocybin with CBT produced significantly higher prolonged abstinence at six months (40.5%) compared to nicotine patch with CBT (10%), with an odds ratio of 6.1. |
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
Comparable studies
Other randomized controlled trials on psilocybin, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety | 2016 | Randomized controlled trial | n = 51 |
| Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression | 2016 | Double-blind, placebo-controlled, crossover trial | n = 29 |
| Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Hallucinogen-naïve adults reporting regular participation in religious or spiritual... | 2006 | Double-blind study | n = 36 |
| Trial of Psilocybin versus Escitalopram for Depression Selected group of patients with depression | 2021 | Randomized controlled trial | |
| Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder Adults aged 21 to 75 years with major depressive disorder, not currently using... | 2020 | Randomized controlled trial | n = 24 |