Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Medical University of South Carolina Identifier:
First received: December 14, 2011
Last updated: June 20, 2016
Last verified: January 2015

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.

Condition Intervention
Smoking Cessation
Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Resource links provided by NLM:

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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


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

Enrollment: 1236
Study Start Date: November 2011
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PREP (Potentially Reduced Exposure Product) Group 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.
No Intervention: cigarette group


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01509586

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Cancer Institute (NCI)
Principal Investigator: Matthew J. Carpenter, Ph.D. Medical University of South Carolina
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medical University of South Carolina Identifier: NCT01509586     History of Changes
Other Study ID Numbers: Pro00007428
R01CA154992 ( US NIH Grant/Contract Award Number )
Study First Received: December 14, 2011
Results First Received: June 20, 2016
Last Updated: June 20, 2016

Keywords provided by Medical University of South Carolina:
smoking cessation
Potentially Reduced Exposure Products (PREPs)

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents processed this record on May 23, 2017