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Nicotine Replacement Therapy
Psilocybin + NRT for Tobacco Use Disorder
N/A
Waitlist Available
Led By Matthew W Johnson, PhD
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 at 2 weeks (pre), 5 weeks (post), and 3 month follow up (for individuals still abstinent at this time point)
Awards & highlights
Study Summary
This trial is testing whether psilocybin, given under supportive conditions, can help people who are nicotine dependent and have unsuccessfully tried to quit smoking in the past.
Eligible Conditions
- Nicotine Addiction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 weeks (pre), 5 weeks (post), and 3 month follow up (for individuals still abstinent at this time point)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks (pre), 5 weeks (post), and 3 month follow up (for individuals still abstinent at this time point)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breath CO
MRI scanning
Urinary cotinine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psilocybin-assisted treatmentExperimental Treatment1 Intervention
Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a high dose of psilocybin (30mg / 70kg) to be administered on the Target Quit Date in week 5.
Group II: Nicotine Replacement Therapy (NRT)Active Control1 Intervention
Participants will receive a 13-week cognitive behavioral intervention for smoking cessation, with a standard 8 to 10-week regimen of NRT to be administered beginning on the Target Quit Date in week 5. NRT for this study will be a transdermal nicotine patch administered according to recommended label usage (For individuals who smoke more than 10 cigarettes per day: 21mg daily weeks 1-6, 14mg daily weeks 7-8, 7mg daily weeks 9-10. For individuals who smoke 10 or less cigarettes per day: 14mg daily for weeks 1-6, 7mg daily for weeks 7-8).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved
Who is running the clinical trial?
Heffter Research InstituteOTHER
13 Previous Clinical Trials
416 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,255 Previous Clinical Trials
14,819,839 Total Patients Enrolled
1 Trials studying Nicotine Addiction
56 Patients Enrolled for Nicotine Addiction
Beckley FoundationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The text discusses the age range 21 to 65 years old.You must not drink alcohol or use any psychoactive drugs for 24 hours before taking psilocybin, except for caffeine and nicotine.You smoke every day, have tried to quit before but couldn't, and still want to quit smoking.You have uncontrolled high blood pressure, chest pain (angina), or a heart condition that can be seen on an ECG. You have had a mini-stroke (TIA) or stroke in the past 6 months, or you have blood vessel disease in your limbs or lungs.You currently have a diagnosed mental health condition such as Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, Major Depression, or Post-traumatic Stress Disorder.Have finished high school.You must not smoke for at least one hour before taking psilocybin, and for at least 30 hours after taking it.One of your close family members (like a parent, sibling, or grandparent) has schizophrenia, bipolar disorder, or a psychotic disorder that is not caused by drugs or a medical condition.You have a history of epilepsy and have experienced seizures.You have diabetes and rely on insulin for treatment. If you take diabetes medication by mouth, you should not have a history of low blood sugar episodes.You are currently taking prescription medicine for mental health on a regular basis.You have any ongoing neurological conditions such as seizures, frequent migraines, multiple sclerosis, movement disorders, a history of severe head injury, or a brain tumor.You have been diagnosed with Schizophrenia, Psychotic Disorder (unless caused by drugs or a medical condition), or Bipolar I or II Disorder in the past or present.You smoke cigarettes every day, have tried to quit before but haven't succeeded yet, and still want to quit.You have had a problem with alcohol or drug addiction in the past 5 years, or have had severe depression.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotine Replacement Therapy (NRT)
- Group 2: Psilocybin-assisted treatment
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial accept participants below the age of fifty?
"The age range for participants in this trial is 21-65 years old. Separate clinical trials exist to accomodate the needs of those younger or older than these parameters, with 8 studies targeting under 18s and 159 looking at patients over 65."
Answered by AI
Are any enrollees being accepted at this time for the trial?
"According to the data found on clinicaltrials.gov, this particular trial is not presently open for recruitment. It was initially posted in September 2008 and revised last August 2022; however, there are 214 other studies that currently require participants."
Answered by AI
Who is eligible to join this clinical investigation?
"The present medical experiment is recruiting 95 nicotine-dependent individuals, ranging in age from 21 to 65. To qualify for the trial, participants must have a high school diploma or equivalent and be daily smokers with multiple past attempts of quitting. Furthermore, they are required to abstain from all psychoactive substances (with the exception of caffeine and nicotine) for 24 hours prior to psilocybin administration as well as one hour before until at least 30 hours afterwards."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Georgia
South Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Neuroimaging Research Branch, NIDA-IRP
Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Behavioral Pharmacology Research Unit: < 48 hours
Average response time
- < 2 Days
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