A single psilocybin dose paired with psychotherapy is "safe and efficacious" for cocaine use disorder (CUD), according to a study published Thursday in JAMA Substance Use and Addiction by the American Medical Association (AMA).
Researchers from the University of Alabama, Johns Hopkins University, and the Karolinska Institute conducted a randomized, quadruple-blind, placebo-controlled trial with 36 participants who met CUD diagnostic criteria. All received cognitive-behavioral psychotherapy one month before and one month after an all-day drug session; during that session, participants were randomly assigned either 25 mg of psilocybin per kilogram of body weight or a placebo.
Compared to the placebo group, psilocybin-treated participants showed significantly higher percentages of cocaine-abstinent days, higher complete-abstinence rates, and a lower risk of cocaine lapse over time, with abstinence confirmed by urinalysis.
"This randomized clinical trial is the first, to our knowledge, to demonstrate that psilocybin coupled with psychotherapy may be safe and efficacious in the treatment of CUD," the authors said, noting that no medications have been proven effective for the condition. The study also "demonstrates that psilocybin treatment can be feasibly implemented with Black and socioeconomically disadvantaged individuals vulnerable to the adverse impacts of CUD but understudied in psychedelic research," addressing a gap identified by a prior systematic review that found U.S. psychedelic trial participants typically have higher socioeconomic status than the general population.
About two months earlier, the AMA published a separate study finding that one psilocybin dose combined with therapy produced "significantly increased long-term abstinence" from cigarettes compared to nicotine patches. A RAND Corporation analysis found that nearly 10 million American adults microdosed psilocybin, LSD, or MDMA in 2025. The National Institutes of Health (NIH) committed $2.4 million to study psychedelics for methamphetamine use disorders, citing a nearly fivefold rise in fatal psychostimulant overdoses between 2015 and 2022, and the National Institute on Drug Abuse (NIDA) launched a $1.5 million psychedelic addiction research funding round in 2023.
The Trump administration has taken steps to explore ibogaine as a treatment for PTSD and substance use disorder. In 2024, the National Center for Complementary and Integrative Health (NCCIH) identified alcohol use disorder as a potential psilocybin benefit, citing a 2022 trial in which psilocybin-assisted therapy participants had fewer heavy-drinking days over 32 weeks than controls.
