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Use and Harm Exposure in New Low Nicotine Cigarettes
NCT01202942 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01202942 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01202942?
The interventions under investigation include: Quest (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01202942?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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