Use and Harm Exposure in New Low Nicotine Cigarettes

Study Overview
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Brief Summary
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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.

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

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Other: Quest


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quest<br>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<br>* Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.<br>|
| No Intervention: Preferred brand<br>Participants smoke their preferred brand of cigarettes for the duration of the study. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |