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

NCT01509586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1236

Last updated 2023-07-12

Study results available
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Summary

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.

Conditions

  • Smoking
  • Smoking Cessation

Interventions

DRUG

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Matthew J. Carpenter, Ph.D. · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509586 on ClinicalTrials.gov