Clinical Trials Directory

Trials / Completed

CompletedNCT03311646

Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
31 (actual)
Sponsor
Medical University of South Carolina · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNormal 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.
OTHERVery 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.

Timeline

Start date
2018-04-15
Primary completion
2018-11-15
Completion
2018-12-01
First posted
2017-10-17
Last updated
2020-01-28
Results posted
2020-01-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03311646. Inclusion in this directory is not an endorsement.