Clinical trial NCT02228824: Very-Low Nicotine Cigarettes and Non-Daily Smokers
Official title: The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Non-daily smokers
Ecological Momentary Assessment
Biomarkers
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-29
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cigarette Consumption
timeFrame: Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period
Secondary outcomes:
measure: Exposure Measure - Solanesol
timeFrame: Post-randomization time points at study weeks 4, 8, 12
measure: Exposure Measure - Smoking Topography
timeFrame: Post-randomization study visits at study weeks 4, 8, 12
measure: Exposure Measure - Cotinine (Logged)
timeFrame: Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)
measure: Exposure Measure - Cigarette Butt Weight
timeFrame: Entire length of study, through completion, up to 12 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Smoking Research Group, University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Department of Psychology
name: Saul Shiffman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shiffman S, Kurland BF, Scholl SM, Mao JM. Nondaily Smokers' Changes in Cigarette Consumption With Very Low-Nicotine-Content Cigarettes: A Randomized Double-blind Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):995-1002. doi: 10.1001/jamapsychiatry.2018.1831.