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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Other: Quest

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Tobacco Use Research Center, UPenn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking topography measures increase as nicotine levels decrease	Every five days over 35 day study participation

Secondary Outcome Measures

Outcome Measure	Time Frame
Nicotine levels effects on smoking topography	Every 5 days over 35 day study participation.
Whether smokers' inferences from advertising affect smoking behavior	Every 5 days over 35 day study participation.
Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease	Every 5 days over 35 day study participation.

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 805584