Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status



Status:Completed
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:3/14/2019
Start Date:September 9, 2015
End Date:February 23, 2018

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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

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.

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
We found this trial at
2
sites
Hershey, Pennsylvania 17033
Principal Investigator: Joshua Muscat, PhD
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from
Hershey, PA
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Washington, District of Columbia 20052
Principal Investigator: Kimberly Horn, PhD
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from
Washington,
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