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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Saul Shiffman, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Smoking Drug: Very low nicotine content cigarettes Drug: Normal nicotine content cigarettes Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Smoking Research Group, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Saul Shiffman
National Cancer Institute (NCI)
Investigators
Principal Investigator: Saul Shiffman, PhD University of Pittsburgh, Department of Psychology
  Study Documents (Full-Text)

Documents provided by Saul Shiffman, University of Pittsburgh:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Saul Shiffman, Research Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02228824     History of Changes
Other Study ID Numbers: 3P30CA047904-25S4 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2014    Key Record Dates
Results First Posted: October 31, 2018
Last Update Posted: October 31, 2018
Last Verified: October 2018

Keywords provided by Saul Shiffman, University of Pittsburgh:
Smoking
Non-daily smokers
Ecological Momentary Assessment
Biomarkers

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action