The study randomized 82 psychiatrically healthy adult smokers: 42 to psilocybin and 40 to nicotine patch treatment. At six months, 17 people in the psilocybin group, or 40.5%, had biochemically verified prolonged abstinence, compared with four people in the nicotine patch group, or 10%.
The secondary measure also favored psilocybin. Researchers found that 52.4% of participants in the psilocybin group had biochemically verified seven-day abstinence at six months, compared with 25% of those using the nicotine patch.
What the psilocybin smoking cessation trial found
The psilocybin arm received one supervised dose of 30 milligrams per 70 kilograms of body weight, while the comparison group began a standard nicotine patch course on the target quit date. The trial registration described the broader approach as psilocybin or nicotine replacement combined with a structured smoking cessation intervention.
The findings matter because cigarette smoking remains one of the country’s most stubborn public health problems. The Centers for Disease Control and Prevention says smoking and secondhand smoke exposure cause more than 480,000 deaths in the U.S. each year, while more than 16 million Americans live with a smoking-related disease.
Nicotine patches are already part of the mainstream treatment toolbox. The CDC lists seven FDA-approved quit-smoking medicines, including nicotine patch, gum, lozenge, oral inhaler and nasal spray, along with varenicline and bupropion SR.
A decade of research led to this comparison
This result did not appear in isolation. In a 2014 Johns Hopkins report, researchers described an open-label pilot study in which 15 longtime smokers received psilocybin in a carefully monitored setting alongside cognitive behavioral therapy. That study reported an 80% abstinence rate at six months, but researchers cautioned at the time that the findings were early and not an endorsement of do-it-yourself psychedelic use.
A long-term follow-up later found that 60% of the original 15 participants were confirmed as abstinent at an average of about 30 months after the target quit date. In 2021, Johns Hopkins said a nearly $4 million National Institutes of Health grant would support a multisite study of psilocybin and talk therapy for quitting smoking, calling it the first federal grant for psychedelic treatment research in more than 50 years in a Johns Hopkins Medicine article.
The new randomized trial gives that earlier research a stronger comparison point. Unlike nicotine replacement therapy, psilocybin does not work by substituting nicotine or directly targeting nicotine withdrawal. The study authors suggested the therapy may act through broader psychological changes, including shifts in self-concept and flexibility, while the counseling program helps participants translate those experiences into behavior change.
Limitations keep the findings preliminary
The trial was small and unblinded, meaning participants and researchers knew which treatment was given. That is a major caveat in psychedelic research because expectancy can shape outcomes. The study population was also mostly White, highly educated and unusually likely to have prior psychedelic experience, which may limit how widely the findings apply.
The comparison was also nicotine patch treatment, not varenicline or combination nicotine replacement therapy, which may be stronger options for some smokers. The psilocybin group also received an intensive, supervised intervention that may be difficult to scale without specialized clinical staffing and dedicated treatment space.
No serious adverse events were attributed to psilocybin or the nicotine patch in the trial, but psilocybin sessions were medically supervised and included monitoring for expected effects such as elevated blood pressure, headache and nausea. Outside research settings, psilocybin remains a Schedule I substance under federal law and is not an FDA-approved smoking cessation treatment.
The takeaway is promising but narrow: psilocybin-assisted therapy may become a serious candidate for smoking cessation if larger, more diverse and better-controlled studies confirm the effect. For now, the trial adds momentum to a research line that has been building for more than a decade while reinforcing that people trying to quit should rely on approved treatments and medical guidance.
