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

Area of Science:

• Psychiatry
• Clinical Psychology
• Pharmacology

Background:

• Tobacco use remains a leading cause of preventable death globally.
• Existing smoking cessation interventions, such as nicotine replacement therapy and cognitive behavioral therapy (CBT), offer modest long-term success rates.
• Novel therapeutic approaches are needed to improve smoking cessation outcomes.

Purpose of the Study:

• To compare the efficacy of psilocybin combined with CBT versus the nicotine patch plus CBT for achieving prolonged smoking abstinence.
• To evaluate the safety and feasibility of psilocybin as a smoking cessation aid.

Main Methods:

• A pilot randomized clinical trial was conducted with psychiatrically healthy adult smokers.
• Participants were randomized to receive either a single high dose of psilocybin or an 8-10 week course of nicotine patch treatment.
• Both groups received a 13-week manualized CBT program for smoking cessation.
• The primary outcome was biochemically verified prolonged smoking abstinence at 6 months post-quit date.

Main Results:

• At 6-month follow-up, 40.5% of participants receiving psilocybin achieved prolonged abstinence compared to 10.0% receiving the nicotine patch (OR=6.12, P=.003).
• Psilocybin also showed higher rates of 7-day point prevalence abstinence (52.4% vs 25.0%, OR=3.30, P=.01).
• No serious adverse events were attributed to either psilocybin or the nicotine patch.

Conclusions:

• A single dose of psilocybin combined with CBT significantly enhanced long-term smoking abstinence rates compared to the nicotine patch plus CBT.
• These findings suggest psilocybin holds promise as a novel and effective pharmacotherapy for tobacco smoking cessation.
• Further research is warranted to confirm these results in larger trials.