Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Smoking

Treatments: Other: Very low nicotine content (VLNC); Other: Normal nicotine content cigarettes (NNC, Baseline)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03311646

R03DA045197 (U.S. NIH Grant/Contract)

950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

31 participants in 1 patient group

Nicotine Content Manipulation

Experimental group

Description:

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.

Treatment:

Other: Very low nicotine content (VLNC)

Other: Normal nicotine content cigarettes (NNC, Baseline)