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
21 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
Researchers are conducting a multi-site, double-blind, randomized clinical trial to study the effects of the 5-HT2A receptor agonist psilocybin compared to niacin for helping adults with tobacco use disorder to quit smoking. This Phase 2 study addresses prior findings from an open-label pilot trial and aims to include a diverse sample across four research sites to better evaluate psilocybins potential efficacy in smoking cessation. Participants will receive two sessions one week apart of either oral psilocybin 30 mg in the first session and either 30 mg or 40 mg in the second session based on their response or oral niacin 150 mg in the first session and either 150 mg or 200 mg in the second session. Both groups also receive cognitive behavioral therapy CBT to support quitting smoking. Niacin serves as an active placebo to help maintain study blinding. During the study, participants will undergo screenings including medical exams, blood tests, ECG, and smoking assessments. Researchers will measure biologically-verified abstinence rates up to 12 months and assess cognitive control and smoking urges at multiple time points before and after the target quit date. Safety monitoring and adherence to abstaining from smoking and psychoactive drugs around dosing sessions are included. The total study participation duration spans up to 12 months with follow-up to evaluate smoking cessation outcomes.
CONDITIONS
Brief 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 with at least 5 cigarettes per day and breath CO of 6 or greater at screening
- Have multiple previous unsuccessful quit attempts and a continued desire to quit smoking
- Able to read, write, and speak English
- Agree to abstain from smoking for at least 1 hour before and 8 hours after psilocybin/niacin sessions
- Agree to avoid psychoactive drugs, including alcohol, within 24 hours of psilocybin/niacin sessions
- Be healthy based on medical interview, physical exam, ECG, and lab tests
You will not qualify if you...
- Use of e-cigarettes or tobacco products other than machine-made cigarettes on more than 5 of the last 30 days
- Pregnant, nursing, or not using effective birth control (for women)
- Positive urine drug screen for illicit drugs (except cannabis)
- Positive breath test for alcohol at screening
- Blood test abnormalities: transaminases >2x upper limit, hemoglobin <11 g/dL, creatinine clearance <40 ml/min
- ECG with corrected QT interval >450 msec
- High baseline vital signs: systolic BP >139 mmHg, diastolic BP >89 mmHg, or heart rate >95 bpm (after up to 3 checks)
- Regular use of antidepressants, antipsychotics, MAO inhibitors, serotonin supplements, or certain other medications
- Current use of smoking cessation medications
- Neurological illnesses such as seizure disorders, frequent migraines, multiple sclerosis, movement disorders, significant head trauma, or CNS tumors
- Recent or extensive psychedelic use (>20 lifetime uses)
- Current or past schizophrenia, psychotic disorders, bipolar disorder, severe major depression, or recent substance use disorders
- Recent history of suicidal behavior or high suicidal ideation
- First- or second-degree relative with psychotic or bipolar disorders
- Current dissociative disorder, anorexia nervosa, bulimia nervosa, major depression, or PTSD
Research Team
M
Matthew Johnson, Ph.D
G
Gideon Naudé, Ph.D.
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