Use and Harm Exposure in New Low Nicotine Cigarettes
| Tracking Information | |
|---|---|
| First Received Date ICMJE | September 14, 2010 |
| Last Updated Date | December 6, 2012 |
| Start Date ICMJE | July 2007 |
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Smoking topography measures increase as nicotine levels decrease [ Time Frame: Every five days over 35 day study participation ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01202942 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Use and Harm Exposure in New Low Nicotine Cigarettes |
| Official Title ICMJE | Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product |
| Brief 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, a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNK and 1-HOP, 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Condition ICMJE | Cigarette Smoking |
| Intervention ICMJE | Other: Quest
Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days. |
| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Enrolling by invitation |
| Estimated Enrollment ICMJE | 210 |
| Estimated Completion Date | May 2013 |
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 21 Years to 65 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT01202942 |
| Other Study ID Numbers ICMJE | 805584 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | University of Pennsylvania |
| Study Sponsor ICMJE | University of Pennsylvania |
| Collaborators ICMJE | National Institutes of Health (NIH) |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Pennsylvania |
| Verification Date | November 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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