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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 : Completed
First Posted : October 17, 2017
Results First Posted : January 18, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Tracy Smith, 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 (NNC, Baseline) Other: Very low nicotine content (VLNC) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants experienced an NNC phase (baseline) and a VLNC phase.
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
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Nicotine Content Manipulation
All participants receive normal nicotine content (NNC) cigarettes during Baseline and all participants receive very low nicotine content (VLNC) cigarettes during the very low nicotine content condition.
Other: Normal nicotine content cigarettes (NNC, Baseline)
Participants will exclusively smoke research cigarettes that have a normal nicotine content for five days/four nights while staying in a hotel.

Other: Very low nicotine content (VLNC)
Participants will exclusively smoke research cigarettes that have a very low nicotine content for five days/four nights while staying in a hotel.




Primary Outcome Measures :
  1. Breath Sample (Expired Carbon Monoxide) [ Time Frame: 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5 ]
    Measure of short term smoke exposure, higher scores indicate more smoke exposure. While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Outcome here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section.

  2. Average Cigarettes Smoked Per Day [ Time Frame: Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition. ]
    Measure of smoking behavior. Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase (NNC and VLNC). Outcomes reported here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section.


Secondary Outcome Measures :
  1. Minnesota Nicotine Withdrawal Scale [ Time Frame: Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. ]
    Measure of withdrawal, Total Score is presented here, Range from 0-60 with higher scores indicating greater withdrawal. Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. Data from the NNC (Baseline) conditions are reported in the baseline section.

  2. Questionnaire of Smoking Urges [ Time Frame: Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition. ]
    Measure of craving, Range from 10-70, Higher scores indicate greater craving. Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition.



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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


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Tracy Smith, PhD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Tracy Smith, Medical University of South Carolina:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tracy Smith, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03311646    
Other Study ID Numbers: 950
R03DA045197 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2017    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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