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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01509586
Recruitment Status : Completed
First Posted : January 13, 2012
Results First Posted : August 1, 2016
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Smoking Smoking Cessation Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
Study Start Date : November 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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



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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509586


Locations
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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)
Investigators
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Principal Investigator: Matthew J. Carpenter, Ph.D. Medical University of South Carolina
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01509586    
Other Study ID Numbers: Pro00007428
R01CA154992 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2012    Key Record Dates
Results First Posted: August 1, 2016
Last Update Posted: August 1, 2016
Last Verified: January 2015
Keywords provided by Medical University of South Carolina:
smoking
smoking cessation
Potentially Reduced Exposure Products (PREPs)
Additional relevant MeSH terms:
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Lobeline
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