Very-Low Nicotine Cigarettes and Non-Daily Smokers

Study Overview
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Brief Summary
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The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.

Detailed Description
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The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.

Official Title
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The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers

Conditions
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Smoking

Intervention / Treatment
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* Drug: Very low nicotine content cigarettes
* Drug: Normal nicotine content cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older, and smoking cigarettes for at least 3 years smoking, on average, 4-27 days per month smoking at current rate for at least the previous 3 months willingness to try novel cigarettes Exclusion Criteria: active plans to quit or actively seeking smoking cessation treatment in the next 3 months severe psychiatric disorders that may interfere with study procedures current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes) [for female participants] being pregnant or breastfeeding, or planning to become pregnant, by self-report current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking occurrence of heart attack, stroke, or angina in the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very low nicotine content cigarettes<br> | Drug: Very low nicotine content cigarettes<br>* 0.07 mg nicotine delivery<br>|
| Active Comparator: Normal nicotine content cigarettes<br> | Drug: Normal nicotine content cigarettes<br>* 0.8 mg nicotine delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cigarette Consumption | Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data | Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure Measure - Solanesol | The concentration of solanesol, a stable marker indicator of how much smoke has passed through the filter of a smoked cigarette to the smoker, will be assayed as a measure of smoking intensity. The filter of a cigarette butts smoked during the baseline period will be compared to those smoked during the experimental period. | Post-randomization time points at study weeks 4, 8, 12 | 
| Exposure Measure - Smoking Topography | Difference between average puff volume per cigarette at laboratory smoking topography sessions at study weeks 4, 8, and 12 across all participants, comparing those assigned to the very-low-nicotine-content cigarette condition to those assigned to the normal-nicotine-content cigarette condition. Topography measures were averaged across all time points for each treatment group. | Post-randomization study visits at study weeks 4, 8, 12 | 
| Exposure Measure - Cotinine (Logged) | Cotinine nicotine exposure measure, analyzed from urine samples taken at study office visits The natural logarithm (ln) of the cotinine measures was used for analysis. Difference in ln(cotinine) between baseline and end of study, from imputed data | Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study) | 
| Exposure Measure - Cigarette Butt Weight | Mean mass smoked per cigarette (calculated as the starting cigarette weight minus returned butt weight) aggregated for all cigarettes smoked among participants assigned to the very-low-nicotine-content cigarette, compared to those assigned to the normal-nicotine-content cigarette condition. | Entire length of study, through completion, up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Non-daily smokers, Ecological Momentary Assessment, Biomarkers