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Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

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ClinicalTrials.gov Identifier: NCT03311646
Recruitment Status : Not yet recruiting
First Posted : October 17, 2017
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Smoking Other: Normal nicotine content cigarettes Other: Lower nicotine content cigarettes

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking
Anticipated Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Normal nicotine content
Cigarettes with a normal nicotine content will be provided
Other: Normal nicotine content cigarettes
Participants will smoke research cigarettes that have a normal nicotine content
Experimental: Lower nicotine content
Cigarettes with a lower nicotine content will be provided.
Other: Lower nicotine content cigarettes
Participants will smoke research cigarettes that have a lower nicotine content


Outcome Measures

Primary Outcome Measures :
  1. Breath sample (expired carbon monoxide) [ Time Frame: Through Study Completion, average of one month ]
    Measure of short term smoke exposure

  2. Cigarettes smoked per day [ Time Frame: Through Study Completion, average of one month ]
    Measure of smoking behavior

  3. Total puff volume [ Time Frame: Through Study Completion, average of one month ]
    Measure of smoking behavior


Secondary Outcome Measures :
  1. Urinary cotinine [ Time Frame: Through Study Completion, average of one month ]
    Measure of nicotine exposure

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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


Eligibility Criteria

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:   Yes
Criteria

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
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): NCT03311646


Contacts
Contact: Tracy Smith, PhD 843-792-5164 smithtra@musc.edu

Sponsors and Collaborators
Medical University of South Carolina
More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03311646     History of Changes
Other Study ID Numbers: 950
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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