5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
ConditionTobacco Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University
About this trial
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 criteria
Qualifiers
21 years old or older
Be a daily smoker (minimum of 5 cigarettes/day on a typical day and breath CO of 6 or greater at screening) with multiple unsuccessful previous quit attempts, and report a continued desire to quit smoking
Read, write, and speak English
Agree to abstain from smoking for the psilocybin/niacin session from 1 hour before psilocybin/niacin administration until at least 8 hours afterward
Disqualifiers
The use of e-cigarettes or tobacco products other than machine-manufactured combustible cigarettes (e.g., cigarillos) on more than 5 of the previous 30 days
Women who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
Positive urine drug screen for illicit drugs (excluding cannabis)
Positive urine breath test for alcohol. Participants with positive tests will be rescheduled
Trial design
Treatments tested in this trial
- Psilocybin
- Niacin
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
University of Alabama at Birmingham
Collaborator
New York University
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov