Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01509586
First received: December 14, 2011
Last updated: June 20, 2016
Last verified: January 2015
Results First Received: June 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Smoking
Smoking Cessation
Intervention: Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PREP (Potentially Reduced Exposure Product) Group 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.
Cigarette Group This group will smoke their normal cigarettes as much or as little as they want to.

Participant Flow:   Overall Study
    PREP (Potentially Reduced Exposure Product) Group     Cigarette Group  
STARTED     626 [1]   610 [1]
Week 3     574     585  
Week 6     551     585  
Week 10     537     574  
Week 14     528     566  
Week18     529     555  
Week 32 (Month 6)     504     523  
Week 46     483     494  
Week 58 (Month 12)     492     499  
COMPLETED     626 [2]   610 [2]
NOT COMPLETED     0     0  
[1] Week 0
[2] final intent to treat sample



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PREP (Potentially Reduced Exposure Product) Group 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.
Cigarette Group This group will smoke their normal cigarettes as much or as little as they want to.
Total Total of all reporting groups

Baseline Measures
    PREP (Potentially Reduced Exposure Product) Group     Cigarette Group     Total  
Number of Participants  
[units: participants]
  626     610     1236  
Age  
[units: years]
Mean (Standard Deviation)
  48.7  (12.5)     48.7  (12.6)     48.7  (12.6)  
Gender  
[units: participants]
     
Female     438     397     835  
Male     188     213     401  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     557     531     1088  
African-American     56     61     117  
Other     13     18     31  
Intend to quit smoking, next month [1]
[units: units on a scale]
Mean (Standard Deviation)
  1.4  (2.3)     1.3  (2.4)     1.4  (2.4)  
Confidence to quit smoking [2]
[units: units on a scale]
Mean (Standard Deviation)
  2.6  (3.1)     2.7  (3.0)     2.7  (3.1)  
Cigarettes per day  
[units: average cigarettes per day at baseline]
Mean (Standard Deviation)
  20.1  (8.7)     19.9  (8.4)     20.0  (8.6)  
[1] 0 - 10 scale, where 0 is no intent to quit and 10 is the most intent to quit smoking in the next 30 days
[2] 0 -10 scale, where 0 is no confidence to quit smoking and 10 is the most confidence to quit smoking, in the next 30 days



  Outcome Measures

1.  Primary:   Quit Attempts and Abstinence   [ Time Frame: From study enrollment through end of one-year follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Matthew J. Carpenter
Organization: Medical University of South Carolina
phone: 843-876-2436
e-mail: carpente@musc.edu



Responsible Party: Medical University of South Carolina
ClinicalTrials.gov 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
Health Authority: United States: Federal Government
United States: Institutional Review Board