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NCT05452772 · ClinicalTrials.gov registry record · Phase 2
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
A Phase 2 study of Tobacco Use Disorder, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 3
- Study locations
NCT05452772: Recruiting Phase 2 study of Tobacco Use Disorder, sponsored by Johns Hopkins University.
NCT05452772 is a Phase 2 study of Tobacco Use Disorder that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 66 participants, below the 238-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (72% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05452772, a Phase 2 study of Tobacco Use Disorder, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
Smoking cessation will be dichotomously coded 7-day point prevalence abstinence at 12-month follow-up. This binary outcome (abstinent versus non-abstinent) will be verified via three measures of recent smoking-(1) timeline follow-back (TLFB), a self-report calendar completed retrospectively by participants indicating the number of cigarettes smoked each day; (2) exhaled carbon monoxide (CO), an objective and biological measure of smoking over approximately the past 24 hours; and (3) urinary coti
Conditions Studied
Interventions
- DRUG Niacin
- DRUG Psilocybin
Study Locations (3)
Alabama
- University of Alabama at Birmingham - Birmingham
Maryland
- Johns Hopkins University School of Medicine - Baltimore
New York
- New York University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What NCT05452772 shows while recruiting
NCT05452772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 238-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Niacin is the first listed.
NCT05452772 reports a single indexed study location in Alabama, Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT05452772 about?
NCT05452772 is a clinical study titled "5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder". 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), a...
What is the current status of trial NCT05452772?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2023-11-01. Estimated completion is 2027-05.
What conditions does trial NCT05452772 study?
This clinical trial studies the following conditions: Tobacco Use Disorder.
What interventions are being tested in trial NCT05452772?
The interventions under investigation include: Niacin (DRUG), Psilocybin (DRUG).
Who is sponsoring clinical trial NCT05452772?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05452772 being conducted?
This trial has 3 study locations across Alabama, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05452772's enrollment target sits among peer trials
66 47th of 70 higher than 24 of 70 other Tobacco Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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