A proposed clinical trial will test whether adding psilocybin-assisted therapy to inpatient rehabilitation for severe alcohol use disorder is feasible and effective. In a double-blind, randomized, placebo-controlled phase II trial, 62 participants aged 21–64 will receive either a high dose (30 mg) or an active placebo dose (5 mg) of psilocybin alongside a brief psychotherapy based on acceptance and commitment therapy. The main outcome is the difference in heavy drinking days from baseline to four weeks after hospital discharge. Secondary outcomes include drinking behavior up to six months, mental health symptoms, neuroplasticity, and cognitive mechanisms. The trial is registered as EudraCT 2022-002369-14 and NCT06160232.
A proposed double-blind, randomized, placebo-controlled phase II trial will test whether adding psilocybin-assisted therapy to a 4-week inpatient rehabilitation program for severe alcohol use disorder is feasible and clinically effective. Sixty-two participants aged 21–64 years will receive either a high dose (30 mg) or an active placebo dose (5 mg) of psilocybin, both paired with a brief acceptance and commitment therapy intervention. The primary clinical outcome is the change in percentage of heavy drinking days from baseline to four weeks after hospital discharge. Secondary outcomes include drinking behavior up to six months, symptoms of depression and anxiety, neuroplasticity, and changes in neurocognitive systems linked to addiction.