Very-Low Nicotine Cigarettes and Non-Daily Smokers
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|ClinicalTrials.gov Identifier: NCT02228824|
Recruitment Status : Completed
First Posted : August 29, 2014
Results First Posted : October 31, 2018
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Drug: Very low nicotine content cigarettes Drug: Normal nicotine content cigarettes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
|Experimental: Very low nicotine content cigarettes||
Drug: Very low nicotine content cigarettes
0.07 mg nicotine delivery
|Active Comparator: Normal nicotine content cigarettes||
Drug: Normal nicotine content cigarettes
0.8 mg nicotine delivery
- Change in Cigarette Consumption [ 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
- Exposure Measure - Solanesol [ 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.
- Exposure Measure - Smoking Topography [ 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.
- Exposure Measure - Cotinine (Logged) [ 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
- Exposure Measure - Cigarette Butt Weight [ 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.
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): NCT02228824
|United States, Pennsylvania|
|Smoking Research Group, University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Saul Shiffman, PhD||University of Pittsburgh, Department of Psychology|