RCT · 2026
Psilocybin vs nicotine patch for quitting smoking: a pilot randomized trial
- Original title
- Psilocybin or Nicotine Patch for Smoking Cessation: A Pilot Randomized Clinical Trial.
- Authors
- Johnson MW, Naudé GP, Hendricks PS, et al.
- Journal
- JAMA network open, 2026
- Molecules
- Psilocybin
- Conditions
- Tobacco use
- Participants
- 82
- Evidence grade
- Moderate
- Source
- Read the original paper
The question
Does a single high dose of psilocybin, added to talk therapy, help people stop smoking better than a nicotine patch added to the same therapy?
What they did
At a medical centre in Baltimore, 82 adult smokers without psychiatric illness were randomly assigned to either one high dose of psilocybin (30 mg per 70 kg of body weight) or 8 to 10 weeks of nicotine patch treatment, both starting on their target quit date. Everyone also received a 13-week structured cognitive behavioural therapy (CBT) program for quitting smoking. Participants and researchers knew which treatment they got. Data were collected between January 20, 2015, and May 8, 2023, and abstinence was confirmed with biological tests six months after the quit date.
What they found
Of the 82 participants (average age 47.6 years, 59.8% male), 68 (82.9%) completed the six-month follow-up. At six months, 17 people in the psilocybin group (40.5%) had confirmed prolonged abstinence, compared with 4 people in the nicotine patch group (10.0%) (odds ratio 6.12; 95% CI, 1.99-23.26; P = .003). For abstinence over the previous seven days, 22 psilocybin participants (52.4%) were abstinent versus 10 patch participants (25.0%) (odds ratio 3.30; 95% CI, 1.32-8.70; P = .01). No serious adverse events were attributed to either treatment.
The fine print
This was a pilot trial with 82 people and no placebo: both participants and investigators knew which treatment was assigned, which can inflate results, especially for a drug with obvious effects. Participants were psychiatrically healthy volunteers at a single academic centre, so the findings may not apply to smokers with mental health conditions. Follow-up ended at six months, the confidence interval for the main result was wide, and an optional crossover was offered after the primary endpoint. This summary is based on the abstract only.
What it means
In this small unblinded trial, one dose of psilocybin combined with structured therapy was linked to higher confirmed quit rates at six months than a nicotine patch with the same therapy. Larger, blinded trials are needed before the size of the benefit can be trusted.
Evidence grade: Moderate. A randomized trial, but a small pilot in which participants and investigators knew which treatment was given, with no placebo control.
This summary is based on the study’s published abstract.