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Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction

Mary P Cosimano, Matthew W. Johnson, Albert Garcia‐romeu, Roland R. Griffiths

Journal of Psychopharmacology September 11, 2014 DOI: 10.1177/0269881114548296 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label pilot study Peer reviewed
Sample size 15
Population Psychiatrically healthy nicotine-dependent smokers
Intervention Psilocybin
Dose 20 mg/70 kg and 30 mg/70 kg
Duration 15-week treatment protocol, 6-month follow-up
Topics Addiction Psilocybin
Keywords Hallucinogen Nicotine Smoking cessation Abstinence Craving
Citations 910
Key points 80% of participants showed seven-day point prevalence abstinence at 6-month follow-up after psilocybin-assisted smoking cessation treatment.

Abstract

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow-up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20 mg/70 kg) and high (30 mg/70 kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction.

In the evidence

This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.

  • 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up, a rate exceeding typical behavioral or pharmacological cessation rates.

    Synthesized

  • 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up, a rate exceeding those typically reported for other behavioral or pharmacological therapies.

    Synthesized

  • Twelve of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up after psilocybin-assisted smoking cessation treatment.

    Synthesized

  • 80% of participants showed seven-day point prevalence abstinence at 6-month follow-up after psilocybin-assisted smoking cessation treatment.

    Synthesized

Comparable studies

Other non-randomized and open-label trials on psilocybin for addiction, most cited first.

Study Year Design Participants
Psilocybin-Occasioned Mystical Experiences in the Treatment of Tobacco Addiction Smokers 2015 Open-label pilot study n = 15
The Psychedelic Debriefing in Alcohol Dependence Treatment: Illustrating Key Change Phenomena through Qualitative Content Analysis of Clinical Sessions Participants in a psilocybin-assisted treatment study for alcohol dependence 2018 Open-label pilot (proof-of-concept) study with qualitative content analysis n = 17
It’s time to take psilocybin seriously as a possible treatment for substance use disorders 2016 Pilot study
Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study Treatment-seeking adults with severe alcohol use disorder 2025 Open-label, single-group study n = 10
Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings People with opioid use disorder 2023 Clinical trial

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