Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Study Overview
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Brief Summary
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The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status

Detailed Description
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To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes. Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.

Official Title
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Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Reduced Nicotine Content Cigarettes
* Drug: Same Nicotine Content Cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Less than 16 years of education Able to understand, and sign consent Smoke >4 cigarettes/day for at least a year No quit attempt in prior 1 month and not planning to quit smoking within next 6 months Plan to live in local area for next 8 months Able to read and write in English Women not pregnant and taking steps to avoid pregnancy Exclusion Criteria: College graduate Use of psychotropic drugs Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months Currently pregnant or nursing Uncontrolled serious psychotic illness or substance abuse History of difficulties providing blood samples-fainting, poor veins, anxiety

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Nicotine Content Cigarettes<br>the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. | Drug: Reduced Nicotine Content Cigarettes<br>* Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette<br>* Other names: Nicotine;|
| Placebo Comparator: Same Nicotine Content Cigarettes<br>The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) | Drug: Same Nicotine Content Cigarettes<br>* about 11.6 mg nicotine per cigarette<br>* Other names: Nicotine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Dropped Out of Study as a Measure of Adherence | Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of Participant Dropout | Baseline participant characteristics were evaluated for their association with the primary outcome, randomized trial phase dropout. The table below reports the number of participants who dropped out by each characteristic that was found to be univariately associated with the primary outcome. | 18 weeks | 
| Cigarettes Per Day | Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back | 18 weeks | 
| Nicotine Exposure | Measured by cotinine (ng/ml) measured in plasma | 18 weeks | 
| Smoke Exposure | Measured in carbon monoxide levels by expired CO | 18 weeks | 
| Perceived Stress | Perceived Stress is measured via the Perceived Stress Scale Score. The 10-item version was used. Scale range is 0-40. Higher scores indicate more stress. | 18 weeks | 
| Cortisol | Salivary Cortisol Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Peak cortisol measures during the cortisol awakening response were used. | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Nicotine