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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01509586
First received: December 14, 2011
Last updated: February 6, 2014
Last verified: January 2014

December 14, 2011
February 6, 2014
November 2011
November 2015   (final data collection date for primary outcome measure)
Prevalence of smokeless tobacco product use in the smokeless tobacco group [ Time Frame: From study enrollment through end of one-year follow up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01509586 on ClinicalTrials.gov Archive Site
Changes in smoking behavior [ Time Frame: From study enrollment through end of one-year follow up ] [ Designated as safety issue: No ]
We will determine changes in each of the following outcomes: 1) cigarette smoking, 2) motivation to quit, 3) confidence to quit. Cigarette smoking will be determined as the average cigarettes per day over the prior 7 days. Change in each outcome will be measured at 3 timepoints, each measured as change since baseline: a) end of tobacco product sampling period, b) 6-month, and c) 12-month follow-up.
Same as current
Not Provided
Not Provided
 
A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Smoking
  • Smoking Cessation
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.
  • Experimental: PREP (Potentially Reduced Exposure Product) Group
    Intervention: Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
  • No Intervention: cigarette group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1400
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01509586
Pro00007428, R01CA154992
No
Medical University of South Carolina
Medical University of South Carolina
National Cancer Institute (NCI)
Principal Investigator: Matthew J. Carpenter, Ph.D. Medical University of South Carolina
Medical University of South Carolina
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP