Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder

This pilot study will collect preliminary data that measures the effects of psychedelic-assisted psychotherapy on patients struggling with alcohol use.

Patients will receive four therapy sessions (lower than in other studies) and will be followed for up to two months after the end of the study. Though smaller in size, the study will help contribute to the literature on psychedelics for alcoholism.

Trial Details

The study design will be a randomized trial where Arm 1 will receive individual psychotherapy sessions plus a psilocybin session (n=10, Psilocybin Group or PG). Arm 2 will receive psychotherapy only (n=10, Control Group or CG). At baseline, subjects will be consented, randomized into one of the two arms, complete psychiatric and medical evaluations, and will undergo a MRI scan. The first two therapy sessions (week 1 and week 2) will be used to learn about the participant's life story, engage the patient, and evoke their reasons for wanting to change their pattern of alcohol use. At week 3, the PG will undergo an 6-8 hour psilocybin-assisted therapy session. The last 2 psychotherapy sessions will be focused on integration of their experiences in the psilocybin session. For the CG, the last 2 sessions will be continued psychotherapy. Therefore, each arm receives 4 psychotherapy sessions. The difference is that the PG group receives an additional session, where they receive psilocybin. After the psychotherapy sessions are completed at the end of week 4, subjects will be followed weekly for 4 weeks. At the last follow-up (week 8), they will undergo a follow-up MRI scan, and a final assessment. At the conclusion of the study, those randomized to the CG will be offered a psilocybin-assisted therapy session, and two follow-up/integration sessions in an open-label extension. The open-label extension will also include an additional 4 weeks of follow-up.

Trial Number NCT05421065

Data attribution

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