Can a single dose of psilocybin help people stop using cocaine?
Yes. In this clinical trial, 30 percent of people who received a single dose of psilocybin were completely off cocaine six months later, compared with 0 percent of those who got a placebo. That works out to 1 extra person fully abstinent for about every 3 people treated. The psilocybin group also had about 29 percentage points more cocaine-free days than the placebo group.
Cocaine use disorder is hard to treat. There is no medication approved by the FDA for it, so doctors mostly rely on talk therapy. This study tested whether one dose of psilocybin, the active ingredient in psychedelic mushrooms, could change that picture when paired with counseling.
Dr. Kumar’s Take
The difference in this trial was clean. Zero percent of the placebo group stayed completely abstinent, while nearly a third of the psilocybin group did. That is a big gap for a condition with almost no tools to treat it. This was a small study with 40 people, though. The blinding also largely failed, so most participants and therapists knew who got psilocybin, and expectations may have played a part. Even with strong results, bigger trials are needed before this becomes anything close to standard care. Still, the safety record was reassuring and the effect size is hard to ignore.
Study snapshot
Researchers at the University of Alabama at Birmingham enrolled 40 adults with cocaine use disorder in a randomized trial designed to be quadruple-blind. That means the patients, the therapists, the people measuring the results, and the people analyzing the data were not supposed to know who got what. In practice, the blinding largely failed. Of the 20 people in the psilocybin group, 18 (90%) correctly guessed they got psilocybin, and the therapists guessed correctly in 39 of 40 cases (97.5%). Half the group received a single oral dose of psilocybin at 25 milligrams per 70 kilograms of body weight. The other half got 100 milligrams of diphenhydramine, an over-the-counter antihistamine used here as an active placebo because it can cause mild sedation. Everyone in the study also received cognitive behavioral therapy, a structured form of counseling that helps people change patterns of thinking and behavior.
Results in context
At the six-month follow-up, the difference between groups was striking. The odds of complete abstinence in the psilocybin group were more than 18 times higher than in the placebo group, with a P value of 0.007, meaning the result is very unlikely to be due to chance. Across the six months, the psilocybin group also reported about 29 percentage points more cocaine-free days, and their risk of a first lapse was 72 percent lower (hazard ratio 0.28). Fewer days of use means less harm to the heart, brain, and daily life, even when the goal of total abstinence is not reached.
Safety and limits
No serious adverse events occurred during the trial. That matters because psilocybin is a powerful psychoactive drug. The trial enrolled people who were motivated to quit and had no significant other health conditions, so the safety record may not apply to people with other mental health conditions. The authors concluded that a single dose appeared both safe and effective in this setting. The main limits to keep in mind are the small sample size, the single-site design, blinding that largely failed (90% of psilocybin participants and therapists in 97.5% of cases guessed correctly), the lead author serving as the primary therapist, which the authors say may have introduced allegiance bias, and the fact that everyone also got therapy, so the study cannot say whether psilocybin would help without the therapy. This work needs to be repeated in larger, more diverse groups before it changes practice.
Practical takeaways
- If you or someone you love is struggling with cocaine use, do not try to source psilocybin on your own, because the safety in this trial depended on careful screening, dosing, and supervised therapy that you cannot replicate at home.
- Cognitive behavioral therapy was part of both arms of the study, so working with a trained therapist remains a core piece of any serious recovery plan, with or without psychedelics.
- Watch for clinical trials in your area if you want access to this kind of treatment legally, since psilocybin is still a controlled substance outside of approved research.
- Talk to your doctor about all current medications and mental health history before considering any psychedelic-assisted therapy, because some conditions and drugs make it unsafe.
Related studies and research
FAQs
How does psilocybin work in addiction treatment?
Psilocybin acts on serotonin receptors in the brain, especially the 5-HT2A receptor, which is involved in mood, perception, and how flexible thinking can be. Researchers think a single high dose may help people step back from rigid patterns of craving and self-defeating thought, sometimes during a single intense session. The therapy that comes before and after the dose helps people make sense of the experience and turn insights into lasting changes. This study did not measure brain activity directly, so the mechanism in cocaine use disorder is still being worked out.
Is psilocybin legal as a treatment for addiction?
Not yet in most places. Psilocybin remains a Schedule I controlled substance under federal law in the United States, which means it can only be used in approved research settings. A few states and cities have changed local rules, and the FDA has granted breakthrough therapy status for psilocybin in depression, which can speed up review. For cocaine use disorder specifically, this trial is one of the first to show a clear benefit, and many more studies will be needed before any clinical approval.
Why was diphenhydramine used as the placebo?
Diphenhydramine is the active ingredient in some over-the-counter sleep aids and allergy medicines like Benadryl. It can cause drowsiness and mild changes in how you feel, which makes it useful as an active placebo. The point of an active placebo is to make blinding more believable so that participants and researchers cannot easily guess who got the real drug. This matters in psychedelic trials because the effects of psilocybin are so obvious that a true sugar pill would give the secret away almost immediately. In this trial, it did not hold up well: 90% of psilocybin participants guessed their group correctly, and the therapists guessed correctly in 97.5% of cases.
Bottom line
A single dose of psilocybin, paired with cognitive behavioral therapy, helped 30 percent of adults with cocaine use disorder stay completely off cocaine for six months, compared with none in the placebo group. The effect was large, though the blinding largely failed and the lead author was the primary therapist. The safety record was clean, and there is currently no FDA-approved medication for this condition, which makes the result genuinely important. Larger trials are still needed, but this is one of the strongest signals so far that psychedelic-assisted therapy could give doctors a real tool for one of the hardest addictions to treat.
