Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-09

Study Completion Date

2018-02-23

Brief Summary

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The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status

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Detailed Description

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To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.

Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Reduced Nicotine Content Cigarettes

the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette.

Group Type EXPERIMENTAL

Reduced Nicotine Content Cigarettes

Intervention Type DRUG

Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette

Same Nicotine Content Cigarettes

The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette)

Group Type PLACEBO_COMPARATOR

Same Nicotine Content Cigarettes

Intervention Type DRUG

about 11.6 mg nicotine per cigarette

Interventions

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Reduced Nicotine Content Cigarettes

Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette

Intervention Type DRUG

Same Nicotine Content Cigarettes

about 11.6 mg nicotine per cigarette

Intervention Type DRUG

Other Intervention Names

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Nicotine Nicotine

Eligibility Criteria

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Inclusion Criteria

* Age 18-65
* Less than 16 years of education
* Able to understand, and sign consent
* Smoke \>4 cigarettes/day for at least a year
* No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
* Plan to live in local area for next 8 months
* Able to read and write in English
* Women not pregnant and taking steps to avoid pregnancy

Exclusion Criteria

* College graduate
* Use of psychotropic drugs
* Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
* Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
* Currently pregnant or nursing
* Uncontrolled serious psychotic illness or substance abuse
* History of difficulties providing blood samples-fainting, poor veins, anxiety

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes