Just one dose of psilocybin combined with therapy is associated with “significantly increased long-term abstinence” from cigarettes compared to nicotine patches, according to a new study published by the American Medical Association (AMA) that indicates the psychedelic “holds potential in the treatment of tobacco use disorder.”
Researchers at Johns Hopkins University School of Medicine and the University of Alabama at Birmingham conducted the study, published in JAMA Substance Use and Addiction, finding more evidence about the therapeutic potential of single-dose psilocybin in tandem with cognitive behavioral therapy (CBT).
The randomized clinical trial of cigarette smokers involved administering one high dose (30mg/70kg) of psilocybin or 8-10 weeks of Food and Drug Administration- (FDA) approved nicotine patch treatment, with both groups participating in a 13-week CBT program for smoking cessation.
“A single psilocybin dose combined with manualized CBT yielded significantly greater smoking abstinence than the nicotine patch paired with the same CBT.”
“A total of 82 psychiatrically healthy adult smokers participated in the study, with 68 (82.9 percent) completing the 6-month follow-up,” the paper says. “At 6-month follow-up, 17 participants receiving psilocybin (40.5 percent) exhibited biochemically verified prolonged abstinence compared with 4 participants using the nicotine patch (10.0 percent), and 22 participants receiving psilocybin (52.4 percent) exhibited biochemically verified 7-day point prevalence abstinence compared with 10 participants using the nicotine patch (25.0 percent).”
Put another way, smokers who received psilocybin had more than six times greater odds of prolonged abstinence and more than three times greater odds of seven-day abstinence compared to the nicotine patch participants.
“In this pilot randomized clinical trial, one dose of psilocybin with manualized CBT significantly increased long-term abstinence compared with nicotine patch treatment with CBT,” the authors said. “Psilocybin abstinence rates were higher than typical treatments, suggesting promise for tobacco smoking cessation.”
“Participants in the psilocybin group smoked a mean of approximately 50 percent fewer [cigarettes per day] between the target quit date and 6-month follow-up,” they said. “The results of this study add to the increasing evidence that psychedelic treatment may have general anti-addiction efficacy across various addictive drugs.”
“Psilocybin’s lack of direct interaction with nicotinic acetylcholine receptors (or receptors mediating the effects of other addictive drugs) highlights psychedelic therapy as a unique approach wherein the pharmacotherapy does not directly alter drug reinforcement or withdrawal but may instead act via higher-order psychological systems, such as changes in self-concept40 and enhanced psychological flexibility. Such mechanisms may also account for transdiagnostic benefits of psychedelic therapies (eg, for depression and anxiety). These psychological changes are likely associated with corresponding biological processes, just as there are presumably biological changes associated with successful psychotherapy. However, these biological processes are probably of a different nature and more difficult to characterize than those of traditional pharmacotherapies.”
The study authors also said that the results of the psilocybin-assisted therapy clinical trial makes the psychedelic a “promising candidate for smoking cessation that should move forward in the FDA process toward potential approval.”
As psychedelics policy reform advances in state legislatures across the U.S. and in Congress, Americans have shown growing interest in exploring the therapeutic potential of substances like psilocybin. To that point, a RAND Corporation analysis recently found that nearly 10 million American adults microdosed psychedelic drugs such as psilocybin, LSD or MDMA in 2025.
A scientific review published by AMA last year that use of psilocybin has “surged” in the U.S. in recent years amid the decriminalization movement and in light of “promising clinical trial results” on its therapeutic potential. But the paper also pointed out that current federal laws present “a major barrier” to researchers gaining a better understanding of the psychedelic substance’s true impacts.
Meanwhile, another study from last year found that psilocybin-assisted psychotherapy “showed significant reductions in alcohol consumption and high smoking cessation rates” and has potential to lessen opioid dependence.
In 2024, meanwhile, two other studies—including one with contributions from a top federal drug official—examined psychedelics and alcohol use disorder (AUD).
One found that a single dose of psilocybin “was safe and effective in reducing alcohol consumption in AUD patients,” while the other concludes that classic psychedelics like psilocybin and LSD “have demonstrated potential for treating drug addiction, especially AUD.”
The National Institutes of Health that year also announced that it would put $2.4 million toward funding studies on the use of psychedelics to treat methamphetamine use disorders—funding that came as federal health officials noted sharp increases in deaths from methamphetamine and other psychostimulants in recent years, with fatal overdoses involving the substances rising nearly fivefold between 2015 and 2022.
In 2023, the National Institute on Drug Abuse (NIDA) announced a $1.5 million funding round to further study psychedelics and addiction.
Other research has also suggested that psychedelics could unlock promising new pathways to treat addiction. A first-of-its-kind analysis in 2023 offered novel insights into exactly how psychedelic-assisted therapy works for people with alcohol use disorder.
In 2024, the National Center for Complementary and Integrative Health (NCCIH), which is part of the National Institutes of Health (NIH), identified the treatment of alcohol use disorder as one of a number of possible benefits of psilocybin, despite the substance remaining a Schedule I controlled substance under U.S. law.
The agency highlighted a 2022 study that “suggested that psilocybin may be helpful for alcohol use disorder.” The research found people who were in psilocybin-assisted therapy had fewer heavy-drinking days over 32 weeks than the control group, which NCCIH said “suggests that psilocybin may be helpful for alcohol use disorder.”
