Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03442413
The ClinicalTrials.gov registry entry for NCT03442413 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 629-participant average among 18 other Smoking, Tobacco trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Smoking, Tobacco
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.
-
ACT Lung Health Intervention: Phase Two
RECRUITING · NA
-
The Efficacy of Conventional Screening Versus mHealth Screening in Early Detection of Oral Potentially Malignant Disorders and Oral Cancer Amongst the Rural Population of Varanasi: A Prospective and Blinded Study
RECRUITING
-
Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
RECRUITING · NA
-
V+PSF-M for Tobacco Cessation in HIV Care in India
RECRUITING · Phase 3
-
A Study Evaluating the Use of an Indoor Air Quality Monitor to Promote a Smoke-free Home
RECRUITING · NA
-
Digitally Enhanced Smoking Cessation for High Risk Smokers
ACTIVE NOT RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.