Use and Harm Exposure in New Low Nicotine Cigarettes

NCT ID: NCT01202942

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-06-30

Brief 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.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Quest

Intervention Type: OTHER

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

Preferred brand

Participants smoke their preferred brand of cigarettes for the duration of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Quest

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

Intervention Type: OTHER

Eligibility 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.

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tobacco Use Research Center, UPenn

Philadelphia, Pennsylvania, United States

Countries

United States

References

DeAtley T, Stone MD, Johnson AC, Mercincavage M, Audrain-McGovern J, Strasser AA. Differences in biobehavioral measures of cigarette smoking by depression symptomology. Addict Behav. 2023 Nov;146:107800. doi: 10.1016/j.addbeh.2023.107800. Epub 2023 Jul 3.

Reference Type: DERIVED

PMID: 37437421 (View on PubMed)

Other Identifiers

805584

Identifier Type: -

Identifier Source: org_study_id