The first randomized, placebo-controlled trial of psilocybin-assisted therapy for cocaine use disorder enrolled 40 adults who wanted to stop using cocaine. All participants received a structured psychotherapy program with cognitive behavioral therapy. One group received a high dose of psilocybin at 25 mg per 70 kg, while the control group received 100 mg diphenhydramine; the study was quadruple blind. Results were reported in this JAMA Network Open article.
Compared with the active placebo, the psilocybin group had more cocaine-free days over 180 days (β 28.95), about 18 times higher odds of complete abstinence, and a 72 percent lower relapse risk. No serious adverse events were reported; transient effects included emotional lability, crying, headache, elevated blood pressure, and altered perception during or shortly after the session.
Important caveats: this was a small pilot with intensive therapy, blinding was often guessed correctly, and people with active major psychiatric comorbidity were largely excluded. The sample was more diverse than typical psychedelic trials, with many Black and lower-income participants. Overall, the findings suggest promise but require confirmation in larger, more rigorous studies.
In short, the first randomized trial found encouraging signals for psilocybin-assisted therapy, but more evidence is needed.