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 range18 Years – 65 Years
SexALL
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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
✕. 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
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
✕. 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