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NCT01202942 · ClinicalTrials.gov registry record · NA
Use and Harm Exposure in New Low Nicotine Cigarettes
A NA study of Cigarette Smoking, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 246
- Enrollment target
- 1
- Study location
NCT01202942 is a NA study of Cigarette Smoking that has completed, run by University of Pennsylvania. The registered enrollment target is 246 participants, above the 171-participant average among 45 other Cigarette Smoking trials with a reported enrollment target (44% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01202942, a NA study of Cigarette Smoking, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 246 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.
Conditions Studied
Interventions
- OTHER Quest
Study Locations (1)
Pennsylvania
- Tobacco Use Research Center, UPenn - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2007-07 |
| Est. Completion | 2013-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01202942
The ClinicalTrials.gov registry entry for NCT01202942 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 171-participant average among 45 other Cigarette Smoking trials with a reported enrollment target (44% higher). 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 Cigarette Smoking appearing as the primary indexed condition, and to 1 intervention - of which Quest is the first listed.
NCT01202942 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01202942 about?
NCT01202942 is a clinical study titled "Use and Harm Exposure in New Low Nicotine Cigarettes". The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking ...
What is the current status of trial NCT01202942?
This trial is currently completed. It is a NA study. The enrollment target is 246 participants. The study started on 2007-07. Estimated completion is 2013-06.
What conditions does trial NCT01202942 study?
This clinical trial studies the following conditions: Cigarette Smoking.
What interventions are being tested in trial NCT01202942?
The interventions under investigation include: Quest (OTHER).
Who is sponsoring clinical trial NCT01202942?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01202942 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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