Very-Low Nicotine Cigarettes and Non-Daily Smokers

Not Applicable

Completed

Conditions: Smoking

Interventions: Drug: Very low nicotine content cigarettes
Drug: Normal nicotine content cigarettes

Registration Number: NCT02228824

Lead Sponsor: Saul Shiffman

Brief Summary: 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.

Detailed Description: The 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 312

Inclusion Criteria

age 18 years or older, and smoking cigarettes for at least 3 years
smoking, on average, 4-27 days per month
smoking at current rate for at least the previous 3 months
willingness to try novel cigarettes

Exclusion Criteria

active plans to quit or actively seeking smoking cessation treatment in the next 3 months
severe psychiatric disorders that may interfere with study procedures
current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
[for female participants] being pregnant or breastfeeding, or planning to become pregnant, by self-report
current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
occurrence of heart attack, stroke, or angina in the past 3 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very low nicotine content cigarettes	Very low nicotine content cigarettes	-
Normal nicotine content cigarettes	Normal nicotine content cigarettes	-

Primary Outcome Measures

Name	Time	Method
Change in Cigarette Consumption	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

Secondary Outcome Measures

Name	Time	Method
Exposure Measure - Solanesol	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	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)	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	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.