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Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

This study is not yet open for participant recruitment.
Verified September 2017 by Medical University of South Carolina
Sponsor:
ClinicalTrials.gov Identifier:
NCT03311646
First Posted: October 17, 2017
Last Update Posted: October 23, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medical University of South Carolina
September 29, 2017
October 17, 2017
October 23, 2017
July 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)
  • Breath sample (expired carbon monoxide) [ Time Frame: Through Study Completion, average of one month ]
    Measure of short term smoke exposure
  • Cigarettes smoked per day [ Time Frame: Through Study Completion, average of one month ]
    Measure of smoking behavior
  • Total puff volume [ Time Frame: Through Study Completion, average of one month ]
    Measure of smoking behavior
Same as current
Complete list of historical versions of study NCT03311646 on ClinicalTrials.gov Archive Site
  • Urinary cotinine [ Time Frame: Through Study Completion, average of one month ]
    Measure of nicotine exposure
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Through Study Completion, average of one month ]
    Measure of withdrawal, Range from 0-32 with higher scores indicating greater dependence
  • Questionnaire of Smoking Urges [ Time Frame: Through Study Completion, average of one month ]
    Measure of craving, Range from 10-70, Higher scores indicate greater craving.
  • Cigarette Evaluation Scale [ Time Frame: Through Study Completion, average of one month ]
    Measure of appeal and acceptability, subscales in satisfaction, reward, aversion, and negative affect reduction, subscales range from 1-7 with higher scores indicating greater intensity for each of those constructs
  • Cigarette Purchase Task [ Time Frame: Through Study Completion, average of one month ]
    Measure of reinforcement value, used to calculate breakpoint (highest price paid for a single cigarette, range from 0-$5.00), intensity (rate of smoking if cigarettes are free, range from 0-limitless), and Omax (maximum amount paid for cigarettes in a single day, range from 0-limitless), higher scores for each parameter indicate higher reinforcement value
  • Perceived Health Risks [ Time Frame: Through Study Completion, average of one month ]
    Measure of risk perception, Range from 1 to 10, Higher scores indicate higher perception of risk
  • Predicted Behavior Questionnaire [ Time Frame: Through Study Completion, average of one month ]
    Predicted use of various tobacco products, Range from not at all likely to extremely likely for each tobacco product
  • Smoking Consequences Questionnaire [ Time Frame: Baseline ]
    Measure of Expectancies, Used to calculate subscales including negative affect reduction, stimulation/state enhancement, health risks, taste/sensorimotor manipulation, social facilitation, weight control, craving/addiction, negative physical feeling, boredom reduction, negative social impression, range for all subscale 0-9 with higher scores indicating greater intensity for each of those constructs.
  • Fagerstrom Test for Nicotine Dependence [ Time Frame: Through Study Completion, average of one month ]
    Measure of Dependence, Range from 0-10, Higher scores indicate greater dependence
  • Wisconsin Inventory of Smoking Dependence Motives [ Time Frame: Through Study Completion, average of one month ]
    Measure of Dependence, Range from 11-77, Higher scores indicate greater dependence
  • Urinary cotinine [ Time Frame: Through Study Completion, average of one month ]
    Measure of nicotine exposure
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Through Study Completion, average of one month ]
    Measure of withdrawal
  • Questionnaire of Smoking Urges [ Time Frame: Through Study Completion, average of one month ]
    Measure of craving
  • Cigarette Evaluation Scale [ Time Frame: Through Study Completion, average of one month ]
    Measure of appeal and accetability
  • Cigarette Purchase Task [ Time Frame: Through Study Completion, average of one month ]
    Measure of demand and reinforcement value
  • Perceived Health Risks [ Time Frame: Through Study Completion, average of one month ]
    Measure of risk perception
  • Predicted Behavior Questionnaire [ Time Frame: Through Study Completion, average of one month ]
    Measure of predicted smoking behavior
  • Smoking Consequences Questionnaire [ Time Frame: Through Study Completion, average of one month ]
    Measure of Expectancies
  • Fagerstrom Test for Nicotine Dependence [ Time Frame: Through Study Completion, average of one month ]
    Measure of Dependence
  • Wisconsin Inventory of Smoking Dependence Motives [ Time Frame: Through Study Completion, average of one month ]
    Measure of Dependence
Not Provided
Not Provided
 
Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.
Smoking is the leading cause of preventable death in the United States. An FDA-mandated reduction in the nicotine content of cigarettes might reduce the health burden of tobacco by reducing the prevalence of smoking. The proposed project will test the impact of nicotine reduction on smoking behavior and smoke exposure in a setting where participants are restricted from using their usual brand cigarettes.Smokers will be confined to a hotel for two hotel stays (five days/ four nights each) during which they will only have access to the investigational cigarettes provided to them. The nicotine content of the investigational cigarettes may differ between the two weeks. Participants will enter the hotel in groups of 10 and everyone in a given stay will receive the same investigational cigarette. The first aim will assess measures of smoke and nicotine exposure including urinary cotinine and expired carbon monoxide. The second aim will assess behavioral measures of smoking including cigarettes smoked per day and puff topography.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Smoking
  • Other: Normal nicotine content cigarettes
    Participants will smoke research cigarettes that have a normal nicotine content
  • Other: Lower nicotine content cigarettes
    Participants will smoke research cigarettes that have a lower nicotine content
  • Experimental: Normal nicotine content
    Cigarettes with a normal nicotine content will be provided
    Intervention: Other: Normal nicotine content cigarettes
  • Experimental: Lower nicotine content
    Cigarettes with a lower nicotine content will be provided.
    Intervention: Other: Lower nicotine content cigarettes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
December 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female participants who are least 18 years old and smoke daily
  • willing to stay in a hotel for two four-night stays during the prearranged dates

Exclusion Criteria:

  • unwilling to use research cigarettes as part of the trial
  • pregnant, trying to become pregnant, or breastfeeding
  • additional smoking and health criteria determined at screening
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Tracy Smith, PhD 843-792-5164 smithtra@musc.edu
Not Provided
 
 
NCT03311646
950
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Medical University of South Carolina
Medical University of South Carolina
Not Provided
Not Provided
Medical University of South Carolina
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP