Use and Harm Exposure in New Low Nicotine Cigarettes

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202942
• Other study ID #: 805584
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: December 17, 2013
• Start date: July 2007
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Tobacco Use Research Center, UPenn	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking topography measures increase as nicotine levels decrease		Every five days over 35 day study participation	Yes
Secondary	Nicotine levels effects on smoking topography		Every 5 days over 35 day study participation.	Yes
Secondary	Whether smokers' inferences from advertising affect smoking behavior		Every 5 days over 35 day study participation.	Yes
Secondary	Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease		Every 5 days over 35 day study participation.	Yes