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Very-Low Nicotine Cigarettes and Non-Daily Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02228824
First Posted: August 29, 2014
Last Update Posted: August 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Saul Shiffman, University of Pittsburgh
  Purpose
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 Intervention
Smoking Drug: Very low nicotine content cigarettes Drug: Normal nicotine content cigarettes

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Saul Shiffman, University of Pittsburgh:

Primary Outcome Measures:
  • Weekly cigarette consumption [ Time Frame: Two-week pre-intervention baseline period and final two-weeks of intervention period (study weeks 11 and 12) ]
    Variation in weekly cigarette consumption between these two periods will be assessed.


Secondary Outcome Measures:
  • Exposure measures [ Time Frame: Two-week pre-intervention baseline period and final two-weeks of intervention period (study weeks 11 and 12) ]
    Composite measures of total exposure will be computed by multiplying per-cigarette exposure measures (e.g., solanesol levels, total puff volume from topography) by total cigarette consumption for the baseline and end-of-study periods, and comparing change across groups.


Enrollment: 312
Study Start Date: September 2014
Study Completion Date: July 31, 2017
Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
University of Pittsburgh
National Cancer Institute (NCI)
Investigators
Principal Investigator: Saul Shiffman, PhD University of Pittsburgh, Department of Psychology
  More Information

Responsible Party: Saul Shiffman, Reserach Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02228824     History of Changes
Other Study ID Numbers: 3P30CA047904-25S4 ( U.S. NIH Grant/Contract )
First Submitted: August 27, 2014
First Posted: August 29, 2014
Last Update Posted: August 15, 2017
Last Verified: August 2017

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