Psilocybin or Nicotine Patch for Smoking Cessation

Summary & key facts

Researchers ran a small randomized trial to compare one high dose of psilocybin plus cognitive behavioral therapy with an FDA-approved nicotine patch plus the same therapy for people trying to quit smoking. Eighty-two psychiatrically healthy adult smokers took part. At six months, about 40% of the people who got psilocybin were still abstinent from smoking, compared with about 10% of the people who used the nicotine patch. No serious harms were linked to either treatment. This is an early, promising result, but it was a small, single-center study and the people and researchers knew which treatment was given, so bigger and more rigorous studies are needed before anyone can say psilocybin is a proven quitting tool.

Key facts:

• The trial included 82 adult smokers and ran at one hospital between early 2015 and mid 2023.
• All participants received a 13-week program of cognitive behavioral therapy, which is a structured type of talk therapy.
• One group received a single high dose of psilocybin along with the therapy.
• The other group started 8 to 10 weeks of an FDA-approved nicotine patch along with the same therapy.
• At six months after the quit date, about 40% of the psilocybin group had verified long-term abstinence from smoking, compared with about 10% of the patch group.
• When measuring whether people had not smoked in the past week at six months, about half of the psilocybin group were abstinent versus about a quarter of the patch group.
• No serious adverse events were attributed to either the psilocybin or the nicotine patch in this study.
• The trial was a pilot study that was small, run at a single center, included only psychiatrically healthy adults, and participants and researchers knew who got which treatment; these factors limit how sure we can be about the results.

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