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Psilocybin for Quitting Smoking
Phase 2
Recruiting
Led By Matthew W Johnson, Ph.D
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial tests if a drug made from a type of magic mushroom can help people quit smoking. Experienced researchers from 3 sites will examine 66 people to see if it works.
Who is the study for?
This trial is for adults over 21 who smoke daily (at least 5 cigarettes/day) and have tried to quit multiple times without success. Participants must be in good health as confirmed by medical exams, not use other tobacco products or psychoactive drugs, including alcohol, before sessions. Pregnant or nursing women and those with certain mental health conditions or cardiovascular issues are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of psilocybin, a psychedelic compound, against niacin in helping people stop smoking. It's double-blind and randomized: participants won't know which treatment they receive during two sessions spaced one week apart at three research sites.See study design
What are the potential side effects?
Psilocybin can cause changes in perception, mood swings, nausea, headache, increased heart rate and blood pressure. Niacin might lead to skin flushing, itching or gastrointestinal upset. The severity of side effects varies from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Potential Efficacy (Smoking Cessation)
Secondary outcome measures
Cognitive control (Multi-Source Interference Task) at Screening (Visit 0)
Cognitive control (Multi-Source Interference Task) at Visit 5
Cognitive control (Multi-Source Interference Task) at Visit 6
+4 moreTrial Design
2Treatment groups
Active Control
Group I: PsilocybinActive Control1 Intervention
30 mg in session 1 and either 30 mg or 40 mg in session 2, with sessions 1 week apart. Dosing will be based on participants' responses to the Mystical Experiences Questionnaire (MEQ30), taken at the end of their first session. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 30 mg of psilocybin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 40 mg for the second session.
Group II: NiacinActive Control1 Intervention
150 mg in session 1 and either 150 mg or 200 mg in session 2, with sessions 1 week apart. Dosing will be based on participants' responses to the Mystical Experiences Questionnaire (MEQ30), taken at the end of their first session. Participants with a score ≥60% of the maximum on the MEQ30 will remain at a dose of 150 mg niacin for the second session. Participants with an MEQ30 score below 60% will receive a dose of 200 mg niacin for the second session.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,431 Total Patients Enrolled
17 Trials studying Tobacco Use Disorder
4,283 Patients Enrolled for Tobacco Use Disorder
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,416 Total Patients Enrolled
5 Trials studying Tobacco Use Disorder
759 Patients Enrolled for Tobacco Use Disorder
New York UniversityOTHER
226 Previous Clinical Trials
314,051 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
585 Patients Enrolled for Tobacco Use Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking antidepressants, antipsychotics, MAOIs, certain dietary supplements, or specific medications like phenytoin.A close family member has schizophrenia, psychosis, or bipolar disorder.I smoke at least 5 cigarettes daily, have tried to quit multiple times without success, and still want to quit.I am healthy based on a recent medical check-up and tests.I am 21 years old or older.I am not pregnant, nursing, or I am using effective birth control.I am currently using medication to help me stop smoking.I have a neurological condition like seizures, MS, or a brain tumor.I smoke at least 5 cigarettes daily, have tried to quit multiple times without success, and still want to quit.I agree not to smoke for at least 9 hours during the psilocybin/niacin session.I have been diagnosed with a specific mental health condition like PTSD or an eating disorder.I have been diagnosed with a severe mental health condition like schizophrenia or major depression.I am generally healthy based on recent medical exams and tests.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin
- Group 2: Niacin
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Tobacco Use Disorder Patient Testimony for trial: Trial Name: NCT05452772 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned psilocybin for use as a therapeutic medication?
"Our team here at Power has provisionally assigned psilocybin a score of 2 due to its current status as being in Phase 2, meaning that while safety is known, efficacy remains untested."
Answered by AI
Is there currently an opportunity for people to take part in this experimental research?
"Clinicaltrials.gov details that this trial, first posted on February 1st 2023 and last modified on December 15th 2022 is not presently recruiting patients. Nevertheless, there are 111 other studies actively enrolling participants at the present time."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Other
Maryland
New Jersey
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
University of Alabama at Birmingham
Johns Hopkins University School of Medicine
New York University
Why did patients apply to this trial?
to quit smoking. I’m hoping to quit smoking for good with the help of this trial.
PatientReceived 1 prior treatment
I have tried 3 different meds, accupuncture, hypnosis, cold turkey. None have worked.
PatientReceived 2+ prior treatments
This was suggested by my therapist. I've tried hypnosis, cold turkey, and other ways with no success.
PatientReceived 2+ prior treatments
Have smoked for 50 years and tried everything from hypnosis to residential programs at Mayo Clinic. Currently on Chantix which helps but does not work 100%.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Johns Hopkins University School of Medicine: < 48 hours
Average response time
- < 2 Days
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