Very-Low Nicotine Cigarettes and Non-Daily Smokers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.

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Detailed Description

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The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Very low nicotine content cigarettes

Group Type EXPERIMENTAL

Very low nicotine content cigarettes

Intervention Type DRUG

0.07 mg nicotine delivery

Normal nicotine content cigarettes

Group Type ACTIVE_COMPARATOR

Normal nicotine content cigarettes

Intervention Type DRUG

0.8 mg nicotine delivery

Interventions

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Very low nicotine content cigarettes

0.07 mg nicotine delivery

Intervention Type DRUG

Normal nicotine content cigarettes

0.8 mg nicotine delivery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 18 years or older, and smoking cigarettes for at least 3 years
* smoking, on average, 4-27 days per month
* smoking at current rate for at least the previous 3 months
* willingness to try novel cigarettes

Exclusion Criteria

* active plans to quit or actively seeking smoking cessation treatment in the next 3 months
* severe psychiatric disorders that may interfere with study procedures
* current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
* exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
* \[for female participants\] being pregnant or breastfeeding, or planning to become pregnant, by self-report
* current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
* occurrence of heart attack, stroke, or angina in the past 3 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No