RecruitingPhase 2NCT05452772

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


Sponsor

Johns Hopkins University

Enrollment

66 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), and New York University (NYU). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Niacin and a drug called Psilocybin for people with tobacco use disorder. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin

Participants will received two psilocybin sessions, 1 week apart

DRUGNiacin

Participants will received two niacin sessions, 1 week apart


Locations(3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

New York University

New York, New York, United States

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NCT05452772


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