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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 : Recruiting
First Posted : October 17, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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 Phase
Smoking Other: Normal nicotine content cigarettes Other: Lower nicotine content cigarettes Not Applicable

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 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
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : November 15, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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




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. 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

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Tracy Smith    843-792-5164    smithtra@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina

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: November 22, 2018
Last Verified: November 2018
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