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

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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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

Quit Attempts and Abstinence

Time frame: From study enrollment through end of one-year follow up

% of study participants making a quit attempt or staying abstinent from smoking during the study

Notes:

Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Jan 13, 2012
Registry last updated: Jul 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed