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NCT03442413 · ClinicalTrials.gov registry record · Phase 1
Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction
A Phase 1 study of Smoking, Tobacco, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT03442413: Active Phase 1 study of Smoking, Tobacco, sponsored by University of Pennsylvania.
NCT03442413 is a Phase 1 study of Smoking, Tobacco that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 13 participants, below the 629-participant average among 18 other Smoking, Tobacco trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03442413, a Phase 1 study of Smoking, Tobacco, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To determine how duration of abstinence affects brain nAChR availability in smokers who metabolize nicotine at slow and normal rates (measured by the nicotine-metabolite ratio (NMR)).
Conditions Studied
Interventions
- DRUG 2-[18F]-FA PET/CT
- DRUG I.V. Nicotine
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-06-28 |
| Est. Completion | 2026-11-22 |
| Phase | Phase 1 |
What the registry record for NCT03442413 still lists
NCT03442413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 629-participant average among 18 other Smoking, Tobacco trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Smoking, Tobacco appearing as the primary indexed condition, and to 2 interventions - of which 2-[18F]-FA PET/CT is the first listed.
NCT03442413 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03442413 about?
NCT03442413 is a clinical study titled "Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction". 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...
What is the current status of trial NCT03442413?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2018-06-28. Estimated completion is 2026-11-22.
What conditions does trial NCT03442413 study?
This clinical trial studies the following conditions: Smoking, Tobacco.
What interventions are being tested in trial NCT03442413?
The interventions under investigation include: 2-[18F]-FA PET/CT (DRUG), I.V. Nicotine (DRUG).
Who is sponsoring clinical trial NCT03442413?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03442413 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03442413's enrollment target sits among peer trials
13 18th of 18 higher than 1 of 18 other Smoking, Tobacco trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking, Tobacco trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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