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OpenTrials
Completed

NCT Number: NCT01202942

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 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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tobacco Use Research Center, UPenn

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quest

Other

Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.

Primary outcomes

  1. Smoking topography measures increase as nicotine levels decrease

    Time frame: Every five days over 35 day study participation

Secondary outcomes

  1. Nicotine levels effects on smoking topography

    Time frame: Every 5 days over 35 day study participation.

  2. Whether smokers' inferences from advertising affect smoking behavior

    Time frame: Every 5 days over 35 day study participation.

  3. Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease

    Time frame: Every 5 days over 35 day study participation.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2010
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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