Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
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|ClinicalTrials.gov Identifier: NCT01928719|
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : March 12, 2019
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Drug: Reduced Nicotine Content Cigarettes Drug: Same Nicotine Content Cigarettes||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status|
|Actual Study Start Date :||September 9, 2015|
|Actual Primary Completion Date :||January 5, 2018|
|Actual Study Completion Date :||February 23, 2018|
Experimental: 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.
Drug: Reduced Nicotine Content Cigarettes
Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
Other Name: Nicotine
Placebo Comparator: 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)
Drug: Same Nicotine Content Cigarettes
about 11.6 mg nicotine per cigarette
Other Name: Nicotine
- Number of Participants Who Dropped Out of Study as a Measure of Adherence [ Time Frame: 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.
- Predictors of Participant Dropout [ Time Frame: 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 [ Time Frame: 18 weeks ]Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back
- Nicotine Exposure [ Time Frame: 18 weeks ]Measured by cotinine (ng/ml) measured in plasma
- Smoke Exposure [ Time Frame: 18 weeks ]Measured in carbon monoxide levels by expired CO
- Perceived Stress [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928719
|United States, District of Columbia|
|George Washington University School of Public Health|
|Washington, District of Columbia, United States, 20052|
|United States, Pennsylvania|
|Penn State College of Medicine|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Joshua Muscat, PhD||Penn State College of Medicine|
|Study Director:||Kimberly Horn, PhD||George Washington University School of Public Health|