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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Johns Hopkins University
Study ID
NCT05452772
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Psilocybin — DRUG
    Participants will received two psilocybin sessions, 1 week apart
  • Niacin — DRUG
    Participants will received two niacin sessions, 1 week apart

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Psilocybin
    30 mg in session 1 and either 30 mg or 40 mg in session 2, with sessions 1 week apart. Dosing will be based on participants' responses to the Mystical Experiences Questionnaire (MEQ30), taken at the end of their first session. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 30 mg of psilocybin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 40 mg for the second session.
  • Active Comparator: Niacin
    150 mg in session 1 and either 150 mg or 200 mg in session 2, with sessions 1 week apart. Dosing will be based on participants' responses to the Mystical Experiences Questionnaire (MEQ30), taken at the end of their first session. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 150 mg niacin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 200 mg niacin for the second session.

Primary Outcome Measure

Potential Efficacy (Smoking Cessation) [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Seher Premani, M.P.H.
[email protected]
205-975-7721
Lindsey Owens, M.A.
[email protected]
205-975-7721
Peter Hendricks, Ph.D. (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University School of MedicineBaltimoreMaryland21224
Hadi Zaki, B.S.
[email protected]
443-291-9154
Matthew Johnson, Ph.D. (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Samantha Khan, M.P.H
[email protected]
646-501-4199
Denise Balili, M.S.
[email protected]
646-501-2623
Michael Bogenschutz, Ph.D. (PRINCIPAL_INVESTIGATOR)

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University of Alabama at Birmingham· Birmingham, ALJohns Hopkins University School of Medicine· Baltimore, MDNew York University· New York, NY

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