Very-Low Nicotine Cigarettes and Non-Daily Smokers

October 5, 2018 updated by: Saul Shiffman

The Effect of Very-Low Nicotine Cigarettes on Smoking in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Smoking Research Group, University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-randomization time points at study weeks 4, 8, 12
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.
Post-randomization study visits at study weeks 4, 8, 12
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
Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)
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.
Entire length of study, through completion, up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saul Shiffman

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Saul Shiffman, PhD, University of Pittsburgh, Department of Psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3P30CA047904-25S4 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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