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
  Purpose

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.


Condition Intervention
Cigarette Smoking
Other: Quest

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Smoking topography measures increase as nicotine levels decrease [ Time Frame: Every five days over 35 day study participation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 246
Study Start Date: July 2007
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Quest
Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.
No Intervention: Preferred brand
Participants smoke their preferred brand of cigarettes for the duration of the study.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202942

Locations
United States, Pennsylvania
Tobacco Use Research Center, UPenn
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01202942     History of Changes
Other Study ID Numbers: 805584
Study First Received: September 14, 2010
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014