Evidence by condition / Tobacco use disorder
Psilocybin for quitting smoking: an early but striking pilot
What the open-label pilot of psilocybin for tobacco addiction and its long-term follow-up found, why there is no control group yet, the randomised trial now recruiting, and free quit help.
Strength of evidenceEarly, uncontrolled evidence
Open-label, observational or case studies without a control group. Suggestive at most. How we grade
- The published evidence is a single open-label pilot of 15 smokers and its long-term follow-up, with no comparison group. (Journal of Psychopharmacology, 2014; The American Journal of Drug and Alcohol Abuse, 2017)
Not medical advice. This page reports what published research, regulators and drug labels say, checked 26 Oct 2026. Talk to a doctor about your own situation; nothing here is a reason to start, stop or change a treatment on your own.
What the research shows
Clinical trialJournal of Psychopharmacology, 2014
Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction
12 of 15 long-term smokers were abstinent at 6 months after psilocybin sessions within a 15-week quit programme, confirmed by biomarkers.
Clinical trialThe American Journal of Drug and Alcohol Abuse, 2017
Long-term follow-up of psilocybin-facilitated smoking cessation
Follow-up of the same 15 smokers: 67% were confirmed abstinent at 12 months and 60% at an average of 30 months.
Each study links to its own page with the design, size, results and limits, checked against PubMed.
Risks to know
Psychosis and severe psychiatric history
Published research safety guidelines recommend excluding volunteers with a personal or family history of psychotic disorders or other severe psychiatric disorders, and note prolonged psychoses triggered by hallucinogens are less common than acute distress. Oregon's Client Information Form bars anyone who has ever been diagnosed with or treated for active psychosis. (Journal of Psychopharmacology, 2008; Oregon Health Authority, Public Health Division, 2026)
Seizures were reported in almost half of lithium plus psychedelic reports.
An analysis of online reports found that 47% of 62 reports of lithium taken with a classic psychedelic (such as psilocybin or LSD) involved seizures and 39% involved medical attention. Oregon's licensed programme bars anyone who has taken lithium in the last 30 days from an administration session. (Pharmacopsychiatry, 2021; Oregon Health Authority, Public Health Division, 2026)
Check your medicines · Screening checklist
Lawful ways to get it
FDA-approved quit aidsFDA-approved
- FDA-approved quit-smoking medicines include over-the-counter nicotine patches, gum and lozenges for adults 18 and over, prescription nicotine nasal spray and inhaler, and two prescription tablets without nicotine, varenicline and bupropion. (U.S. Food and Drug Administration, 21 Jul 2022)
Clinical trialsClinical trials
- No psilocybin medicine is approved for any use; trials are the lawful route. (eCFR (Office of the Federal Register), current; U.S. Food and Drug Administration, Jul 2026)
- A listing on ClinicalTrials.gov means the sponsor registered the study, not that the US government evaluated it. (U.S. National Library of Medicine (NIH), Oct 2023)
What it costs
- Ask any trial team whether taking part costs anything, which expenses such as travel or lodging are reimbursed, and whether your insurance covers what the research does not. (National Institute on Aging (NIH), current page)
Recruiting trials for tobacco use disorder
2 trials were recruiting on ClinicalTrials.gov on 26 Oct 2026, 2 with US sites, testing any psychedelic or ketamine; 2 of them test Psilocybin. The first 2 are below.
Early phase 1PsilocybinNCT07118332
Psilocybin as a Treatment for Chronic Pain in Smokers
- Conditions:
- Smokers With Chronic Pain
- Sponsor:
- Yale University
- Who:
- ages 21 Years to 65 Years, 10 participants planned
- Department of Veterans Affairs, West Haven, Connecticut (not yet recruiting)
- Department of Veterans Affairs, West Haven, Connecticut
Phase 2PsilocybinNCT05452772
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
- Conditions:
- Tobacco Use Disorder
- Sponsor:
- Johns Hopkins University
- Who:
- ages 21 Years and over, 66 participants planned, accepts healthy volunteers
- University of Alabama at Birmingham, Birmingham, Alabama