Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Smoking Clinical Trial

Official title:

Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311646
• Other study ID #: 950
• Secondary ID: R03DA045197
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 1, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath Sample (Expired Carbon Monoxide)	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.	8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5
Primary	Average Cigarettes Smoked Per Day	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.	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.
Secondary	Minnesota Nicotine Withdrawal Scale	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.	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.
Secondary	Questionnaire of Smoking Urges	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.	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.