Impact of Exclusive Use of Low Nicotine Cigarettes on Compensatory Smoking

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2018-12-01

Brief Summary

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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.

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Detailed Description

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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

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Smoking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants experienced an NNC phase (baseline) and a VLNC phase.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Normal nicotine content cigarettes (NNC, Baseline)

Intervention Type OTHER

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)

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes