5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder

Brief description of study

The purpose of this double-blind randomized study is to explore the efficacy of psilocybin (5-HT2A receptor agonist psilocybin) as a smoking cessation treatment. In this study participants will be randomized to receive either:

  1. psilocybin; 30 mg in session 1 and either 30 or 40 mg in session 2, with sessions 1 week apart; or
  2. niacin; 100 mg in session 1 and either 100 mg or 200 mg in session 2, with sessions 1 week apart

Cognitive behavior therapy (CBT) will be administered to both groups and will allow us to test psilocybin’s efficacy above and beyond an established treatment approach. The total study duration will be approximately 12 months after screening and enrollment, and include roughly 14 in-person visits for screening, study intervention, psilocybin sessions, and follow-up meetings.

Clinical Study Identifier: s22-00503
ClinicalTrials.gov Identifier: NCT05452772
Principal Investigator: Michael P. Bogenschutz.

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