Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer.
Charles S Grob, Alicia L Danforth, Gurpreet S Chopra...
https://pubmed.ncbi.nlm.nih.gov/20819978Actively Recruiting
Phase 2
Age: 21Years +
All Genders
Healthy Volunteers
ID05452772
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 psilocybin's 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
Age: 21Years +
All Genders
Healthy Volunteers
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 weeks
Participants receive two medication sessions (psilocybin or niacin) spaced 1 week apart, combined with cognitive behavioral therapy (CBT) to support smoking cessation.
2 medication sessions and multiple CBT sessions during treatment
Follow-up
Duration - Up to 12 months
Participants are monitored for smoking abstinence and cognitive outcomes for up to 12 months after treatment completion.
Regular follow-up visits for assessments up to 12 months
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
Loading map...
Research Team
M
Matthew Johnson, Ph.D
G
Gideon Naudé, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction.
Matthew W Johnson, Albert Garcia-Romeu, Mary P Cosimano...
https://pubmed.ncbi.nlm.nih.gov/25213996Long-term follow-up of psilocybin-facilitated smoking cessation.
Matthew W Johnson, Albert Garcia-Romeu, Roland R Griffiths
https://pubmed.ncbi.nlm.nih.gov/27441452Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial.
Stephen Ross, Anthony Bossis, Jeffrey Guss...
https://pubmed.ncbi.nlm.nih.gov/27909164