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

NCT05452772 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-07-29

No results posted yet for this study

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.

Conditions

  • Tobacco Use Disorder

Interventions

DRUG

Psilocybin

Participants will received two psilocybin sessions, 1 week apart

DRUG

Niacin

Participants will received two niacin sessions, 1 week apart

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • New York University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Matthew Johnson, Ph.D · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2026-12-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452772 on ClinicalTrials.gov