Comparison of High- Versus Low-Dose Psilocybin to Prevent Relapse in Adults with Alcohol Use Disorder and Depression

What this Trial Is About

Researchers are investigating the use of psilocybin-assisted psychotherapy PAP to prevent relapse in adults with alcohol use disorder AUD who also experience depressive symptoms. This study compares the effects of high-dose versus low-dose psilocybin in reducing relapse risk over six months. The study builds on earlier pilot findings suggesting psilocybin may reduce drinking days and cravings, offering a potentially faster-acting option than traditional antidepressants for individuals with AUD and depression. Participants receive two doses of psilocybin, either a high dose of 25 mg or a low dose of 3 mg, administered three weeks apart. The study uses a randomized, parallel design, with participants assigned to either the high-dose or low-dose group to evaluate differences in relapse prevention. A third dose may be offered later based on participant request and study assessments. During the study, participants are closely monitored with scheduled assessments of drinking behavior, craving, depressive symptoms, anxiety, quality of life, and other psychological factors. Various tests and questionnaires are administered at baseline and multiple follow-up points up to 51 weeks. Safety and tolerance of psilocybin are also evaluated. The total participation duration extends to about one year, allowing detailed observation of relapse rates and related outcomes.

Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms