NCT03442413

Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction

The Influence of Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking, Tobacco

Interventions

Type	Name	Description
DRUG	2-[18F]-FA PET/CT	2-\[18F\]FA is a highly specific radiotracer which has been used successfully to image nicotinic acetylcholine receptors in the human brain to characterize the effects of nicotine exposure (via smoking) on these receptors.
DRUG	I.V. Nicotine	Subjects in our study will receive intravenous nicotine at the adaptation session and each of the PET scans, close to the amount of nicotine absorbed from smoking 1/10 cigarette.

Timeline

• Start date: 2018-06-28
• Primary completion: 2026-11-22
• Completion: 2026-11-22
• First posted: 2018-02-22
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study