Use and Harm Exposure in New Low Nicotine Cigarettes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01202942
First received: September 14, 2010
Last updated: December 17, 2013
Last verified: November 2012

September 14, 2010
December 17, 2013
July 2007
May 2013   (final data collection date for primary outcome measure)
Smoking topography measures increase as nicotine levels decrease [ Time Frame: Every five days over 35 day study participation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01202942 on ClinicalTrials.gov Archive Site
  • Nicotine levels effects on smoking topography [ Time Frame: Every 5 days over 35 day study participation. ] [ Designated as safety issue: Yes ]
  • Whether smokers' inferences from advertising affect smoking behavior [ Time Frame: Every 5 days over 35 day study participation. ] [ Designated as safety issue: Yes ]
  • Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease [ Time Frame: Every 5 days over 35 day study participation. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Use and Harm Exposure in New Low Nicotine Cigarettes
Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cigarette Smoking
Other: Quest
Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.
  • Experimental: Quest
    Participants smoke Quest cigarettes level 1 for 10 days, followed by level 2 for 10 days, and finally by level 3 for 10 days.
    Intervention: Other: Quest
  • No Intervention: Preferred brand
    Participants smoke their preferred brand of cigarettes for the duration of the study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
June 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Self-report smoking > 15 daily cigarettes.
  • Self-report smoking only non-menthol cigarettes.
  • Not currently trying to quit smoking, or planning to quit in the next 2 months.
  • Interested in trying a new cigarette-like product.

Exclusion Criteria:

  • Not meeting any of the inclusion criteria.
  • Self-report drinking > 25 alcohol-containing drinks per week.
  • Self-report currently using any nicotine replacement products.
  • Self-report substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines, not nicotine) in the last 5 years.
  • Self-report past history of Axis I psychiatric disorders other than depression
  • Self-report myocardial infarct within the past year.
  • Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating.
  • Provide a baseline CO reading < 10 ppm
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01202942
805584
Yes
University of Pennsylvania
University of Pennsylvania
National Institutes of Health (NIH)
Not Provided
University of Pennsylvania
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP