Psilocybin or Nicotine Patch for Smoking Cessation

Summary & key facts

This small randomized trial compared one high dose of psilocybin plus a 13-week quitting program with the usual nicotine patch plus the same program in adult smokers. Six months after the quit date, about 40% of people given psilocybin were still not smoking, compared with about 10% of people using the patch. The study was done at a single center, was unblinded (people and staff knew which treatment was given), and involved psychiatrically healthy adults, so the results are promising but preliminary and need more testing in larger, more diverse groups.

Key facts:

• The study enrolled 82 psychiatrically healthy adult cigarette smokers at Johns Hopkins between 2015 and 2023.
• Everyone in the study received the same 13-week program of cognitive behavioral therapy, which is a structured form of therapy that teaches skills to change habits and thoughts tied to smoking.
• One group received a single high dose of psilocybin on the quit date. The other group started 8 to 10 weeks of FDA-approved nicotine patch treatment on the quit date.
• At the six-month check, about 40% of people given psilocybin showed biochemically verified prolonged abstinence, meaning lab tests supported they were not smoking, versus about 10% in the patch group.
• For a seven-day check at six months, about 52% of the psilocybin group were not smoking, compared with about 25% of the patch group.
• No serious adverse events were attributed to either psilocybin or the nicotine patch in this trial.
• The trial was a pilot study and unblinded. That means the study was small and both participants and researchers knew who got which treatment. These features limit how sure we can be and mean the findings need confirmation in larger, blinded studies.

Abstract

Importance: Annual tobacco-related death estimates are 480 000 in the US and 8 million worldwide, surpassing mortality for other abused substances. Most smoking cessation interventions result in modest long-term success. Objective: To compare prolonged smoking abstinence rates in smokers receiving psilocybin plus cognitive behavioral therapy (CBT) with those receiving the nicotine patch plus CBT. Design, Setting, and Participants: In this pilot randomized clinical trial, participants and investigators were unblinded to treatment condition, including an optional crossover after completion of the primary end point. Data were collected from psychiatrically healthy adult smokers from January 20, 2015, to May 8, 2023, at the Johns Hopkins Bayview Medical Center, an academic medical center and teaching hospital in Baltimore, Maryland. Intervention: The trial randomized cigarette smokers to receive either 1 high dose (30 mg/70 kg) of psilocybin or initiate 8 to 10 weeks of US Food and Drug Administration-approved nicotine patch treatment on the target quit date. Both groups received a 13-week manualized CBT program for smoking cessation. Main Outcomes and Measures: Biochemically verified prolonged smoking abstinence (primary) and 7-day point prevalence abstinence (secondary) at 6 months after the target quit date were compared between groups using intention-to-treat analysis. Results: A total of 82 psychiatrically healthy adult smokers (mean [SD] age, 47.6 [12.0] years; 49 [59.8%] male) participated in the study, with 68 (82.9%) completing the 6-month follow-up. At 6-month follow-up, 17 participants receiving psilocybin (40.5%) exhibited biochemically verified prolonged abstinence compared with 4 participants using the nicotine patch (10.0%) (odds ratio, 6.12; 95% CI, 1.99-23.26; P = .003), and 22 participants receiving psilocybin (52.4%) exhibited biochemically verified 7-day point prevalence abstinence compared with 10 participants using the nicotine patch (25.0%) (odds ratio, 3.30; 95% CI, 1.32-8.70; P = .01). No serious adverse events were attributed to psilocybin or nicotine patch. Conclusions and Relevance: In this pilot randomized clinical trial, 1 dose of psilocybin with manualized CBT significantly increased long-term abstinence compared with nicotine patch treatment with CBT. Psilocybin abstinence rates were higher than typical treatments, suggesting promise for tobacco smoking cessation. Trial Registration: ClinicalTrials.gov Identifier: NCT01943994.

Topics

Forensic Toxicology and Drug Analysis Psychedelics and Drug Studies Smoking Behavior and Cessation

Categories

Clinical Psychology Psychology Social Sciences

Tags

Abstinence Adjunctive treatment Anesthesia Cigarette smoking Clinical endpoint Clinical trial Craving Crossover study Dosing Drug Hallucinogen Internal medicine Medicine Nicotine Nicotine patch Nicotine withdrawal Pharmacotherapy Placebo Psilocybin Psychiatry Psychological intervention Randomized controlled trial Relapse prevention Smoking cessation Varenicline Young adult

Substances

Psilocybin

Conditions & symptoms

Addiction Substance abuse disorder Addiction or harmful habbits