Safety, Efficacy, and Blinding Integrity of Psilocybin-Assisted Therapy for Substance Use Disorders: A Systematic Review of Randomized Controlled Trials
Open MIND June 26, 2026 Max Courtney
Substance use disorders remain a major public health challenge, and existing treatments often have limited long-term success. Psilocybin-assisted therapy (PAT) has recently attracted renewed research interest as a potential treatment for addictions including alcohol, tobacco, and opioids. Most prior studies have been observational or non-randomized, but the number of randomized controlled trials (RCTs) has grown rapidly. This systematic review will examine only RCTs to evaluate the safety, efficacy, and blinding integrity of PAT for substance use disorders. It will assess changes in substance use, adverse events, and how well double-blinding works given psilocybin's strong psychoactive effects. A narrative synthesis is planned, organized by substance type, safety outcomes, and blinding, using the SWiM reporting guideline.