Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction (NCT03442413) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction
United States13 participantsStarted 2018-06-28
Plain-language summary
Physically healthy adult smokers may be eligible for this study. Volunteers may participate in this study if they are 18 - 65 years old.
Subjects will participate in two separate 7-hour PET/CT Scan Sessions (each with 2 hours of actual PET/CT scanning): one following an overnight abstinence and one following two overnights of abstinence. To achieve and confirm two overnights of abstinence, participants will present to the inpatient CHPS the day prior to the scheduled scan and stay overnight.
The 2-\[18F\]-FA PET/CT brain scans will consist of an injection followed by an 7-hour infusion of 2-\[18F\]-FA. The scan session will begin at approximately 4 hours after the bolus injection. The PET/CT scan will occur in two segments. Starting at approximately 4 hours post bolus and infusion start, we will scan for approximately 90 minutes with a bolus injection of IV nicotine that will occur approximately 15 minutes into the scanning procedure. There will be a break in scanning of approximately 60 minutes, during which subjects will be allowed to get off the scanner and use the restroom, if necessary. The second scan segment will start at approximately 6.5 hours post bolus injection, t. This segment will last approximately 30 minutes. The pre and post nicotine images will be analyzed to evaluate for differences in receptor uptake after the nicotine "challenge".
Subjects will have a structural Brain MRI performed within 1 year prior to study enrollment or subjects who have not had a Brain MRI that is deemed acceptable for use for this study will undergo a research Brain MRI after consent.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants will be 18-65 years of age
. Self-reported cigarette smoking history of at least 10 cigarettes/day for at least 6 months prior to enrollment
. Carbon monoxide reading \> 10 ppm at the initial screening session
. Participants agree to be compliant with all study procedures including smoking abstinence and willingness to complete over-night stays at the Hospital of the University of Pennsylvania
. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of abstinence affects brain nAChR availability in smokers
Timeframe: 2 years
2
How nicotine administration affects nAChR availability during early abstinence in smokers
. Women who are pregnant at the time of screening will not be eligible for this study. A urine pregnancy test will be performed in women of childbearing potential at screening.
. Self-reported regular (daily) use of chewing tobacco, snuff or snus
. Current enrollment in a smoking cessation or research program involving the use of nicotine substitutes
. History within one year or currently receiving treatment for substance abuse other than nicotine (e,g,, alcohol, opioids, cocaine, marijuana, or stimulants)
. Current use of cocaine, methamphetamines or other psychoactive substances per self-report and/or positive urine drug screen at the initial screening session
. Self-reported current alcohol consumption that exceeds greater than 25 drinks per week in men and 18 drinks per week in women
. BrAC reading greater than or equal to 0.01% at the initial screening session
. History of kidney and/or liver disease per medical record review or self-reported