Journal of Psychopharmacology

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

Trial paperopen

Cosimano, M. P., Garcia-Romeu, A., Griffiths, R. R., Johnson, M. W.

This is the first study to use psilocybin and cognitive behavioural therapy (CBT) in concert for smoking cessation in an open-label format. Participants received a moderate (20 mg/70kg) and high (30 mg/70kg) of psilocybin with a 15-week smoking cessation protocol. At the six-month follow-up, 80% of participants were smoking-free.

Abstract

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, the 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 the smoking status and self-report measures of smoking behaviour 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 behavioural 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..