Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: Normal nicotine content cigarettes (NNC, Baseline); Other: Very low nicotine content (VLNC)

• Registration Number: NCT03311646
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Start: 2018-04-15
• Primary Completion: 2018-11-15
• Study Completion: 2018-12-01
• Status Verified: 2020-01
• Results First Submitted: 2020-01-02
• Results First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-18
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicotine Content Manipulation	Normal nicotine content cigarettes (NNC, Baseline)	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.
Nicotine Content Manipulation	Very low nicotine content (VLNC)	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.

Primary Outcome Measures

Name	Time	Method
Breath Sample (Expired Carbon Monoxide)	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.
Average Cigarettes Smoked Per Day	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

Name	Time	Method
Minnesota Nicotine Withdrawal Scale	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.
Questionnaire of Smoking Urges	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States