Actively Recruiting
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
Led by Johns Hopkins University · Updated on 2025-07-29
66
Participants Needed
3
Research Sites
182 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
U
University of Alabama at Birmingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 years old or older
- Daily smoker of at least 5 cigarettes per day with breath CO of 6 or greater at screening
- Multiple unsuccessful previous quit attempts and a continued desire to quit smoking
- Able to read, write, and speak English
- Agree to abstain from smoking from 1 hour before until at least 8 hours after psilocybin/niacin sessions
- Agree to avoid psychoactive drugs, including alcohol, within 24 hours of psilocybin/niacin sessions
- Healthy as determined by interview, medical questionnaire, physical exam, ECG, and lab tests
You will not qualify if you...
- Use of e-cigarettes or tobacco products other than machine-manufactured cigarettes on more than 5 of the previous 30 days
- Pregnant, nursing, or not using effective birth control
- Positive urine drug screen for illicit drugs (excluding cannabis)
- Positive urine breath test for alcohol
- Lab values: transaminases > 2x upper normal limit, hemoglobin < 11 g/dL, creatinine clearance < 40 ml/min
- ECG with corrected QT interval (QTc) > 450 msec
- Baseline vital signs exceeding SBP > 139 mmHg, DBP > 89 mmHg, or heart rate > 95 bpm on 3 attempts
- Regular use of antidepressants, antipsychotics, MAOIs, serotonin-acting supplements, or certain enzyme inhibitors
- Current use of smoking cessation medications
- Current neurological illnesses including seizure disorders, frequent migraines, multiple sclerosis, movement disorders, significant head trauma, or CNS tumor
- Recent or extensive psychedelic use (>20 lifetime uses)
- Current or past diagnosis of schizophrenia, psychotic disorders, bipolar disorder, severe major depression, or substance/alcohol use disorder within past 5 years
- Recent history of suicidal behavior or high suicidal ideation
- First- or second-degree relative with schizophrenia, psychotic disorder, or bipolar disorder
- Current diagnosis of dissociative disorder, anorexia nervosa, bulimia nervosa, major depression, or PTSD
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
3
New York University
New York, New York, United States, 10016
Actively Recruiting
Research Team
M
Matthew Johnson, Ph.D
CONTACT
G
Gideon Naudé, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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