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Completed

NCT Number: NCT02228824

Very-Low Nicotine Cigarettes and Non-Daily Smokers

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Smoking Research Group, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very Low Nicotine Content Cigarettes

Drug

0.07 mg nicotine delivery

Normal Nicotine Content Cigarettes

Drug

0.8 mg nicotine delivery

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Saul Shiffman

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2014
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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