Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Not Applicable

Completed

Interventions: Drug: Reduced Nicotine Content Cigarettes
Drug: Same Nicotine Content Cigarettes

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Reduced Nicotine Content Cigarettes	Reduced Nicotine Content Cigarettes	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.
Same Nicotine Content Cigarettes	Same Nicotine Content Cigarettes	The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Dropped Out of Study as a Measure of Adherence	18 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Predictors of Participant Dropout	18 weeks	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.
Cigarettes Per Day	18 weeks	Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back
Nicotine Exposure	18 weeks	Measured by cotinine (ng/ml) measured in plasma
Smoke Exposure	18 weeks	Measured in carbon monoxide levels by expired CO
Perceived Stress	18 weeks	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.
Cortisol	15 weeks	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.

Locations (2): George Washington University School of Public Health
🇺🇸
Washington, District of Columbia, United States
Penn State College of Medicine
🇺🇸
Hershey, Pennsylvania, United States