Smoking Research Group, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT02228824
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.
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Notify MeThe 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.07 mg nicotine delivery
0.8 mg nicotine delivery
Time frame: Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period
Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data
Time frame: Post-randomization time points at study weeks 4, 8, 12
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.
Time frame: Post-randomization study visits at study weeks 4, 8, 12
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.
Time frame: Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)
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
Time frame: Entire length of study, through completion, up to 12 weeks
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.
Saul Shiffman
Other
The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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