A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-03-31

Brief Summary

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This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.

Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.

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Detailed Description

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Conditions

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Smoking Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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PREP (Potentially Reduced Exposure Product) Group

Group Type EXPERIMENTAL

Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

Intervention Type DRUG

The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.

cigarette group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age \>=19
* a daily cigarette smoker of \>=10 cigs/day
* English speaking
* live in the contiguous U.S.
* unmotivated to quit smoking in the next 30 days

Exclusion Criteria

* no use of smokeless tobacco in past six months
* not breastfeeding, pregnant, or planning a pregnancy
* devoid of any recent (past 6 months) cardiovascular trauma
* no quit attempt of \>=1 week in past 6 months
* no use of pharmacotherapy to quit smoking in past 3 months

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No