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Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

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ClinicalTrials.gov Identifier: NCT00711100
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : September 16, 2015
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tobacco Use Disorder
Interventions Other: Camel Snus
Other: Marlboro Snus
Other: Stonewall
Other: Ariva
Other: General Snus
Enrollment 104

Recruitment Details Subjects were recruited 10/2008 through 8/2009 through local advertisements in Minnesota and Oregon.
Pre-assignment Details Sampling Phase preceded the 2 week Abstinence Phase. Sampling phase involved sampling each study product for a 1/2 day; subjects then chose the product that they would like to use for a two week cigarette abstinence period
Arm/Group Title Oral Tobacco Products
Hide Arm/Group Description Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
Period Title: Overall Study
Started 104
Completed 91
Not Completed 13
Reason Not Completed
Lack of Efficacy             5
Withdrawal by Subject             8
Arm/Group Title Oral Tobacco Products
Hide Arm/Group Description Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva
Overall Number of Baseline Participants 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
<=18 years
2
   1.9%
Between 18 and 65 years
97
  93.3%
>=65 years
5
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants
40.1  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Female
40
  38.5%
Male
64
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants
104
1.Primary Outcome
Title Product Preference
Hide Description Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Camel Snus Marlboro Snus Stonewall Ariva General Snus
Hide Arm/Group Description:
Number of participants who sampled Camel Snus
Number of participants who sampled Marlboro Snus
Number of participants who sampled Stonewall
Number of participants who sampled Ariva
Number of partiicipants who sampled General Snus
Overall Number of Participants Analyzed 98 98 98 98 98
Measure Type: Number
Unit of Measure: participants
27 23 24 24 0
2.Primary Outcome
Title Abstinence From Cigarettes
Hide Description Abstinence from cigarettes during Abstinence Phase.
Time Frame Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
At the end of Sampling Phase, subjects chose a preferred product to use during a two week Abstinence Phase. Abstinence from cigarettes was determined during the 2 week study product phase (e.g., Abstinence Phase) and 1 week after this phase.
Arm/Group Title Camel Snus Marlboro Snus Stonewall Ariva
Hide Arm/Group Description:
Number of participants who preferred this product during abstinence phase
Number of participants who preferred this product during abstinence phase
Number of participants who preferred this product during abstinence phase
Number of participants who preferred this product during abstinence phase
Overall Number of Participants Analyzed 27 23 24 24
Measure Type: Count of Participants
Unit of Measure: Participants
12
  44.4%
8
  34.8%
5
  20.8%
3
  12.5%
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Camel Snus Marlboro Snus Stonewall Ariva General Snus
Hide Arm/Group Description Participant who sampled Camel Snus Participants who sampled Marlboro Snus Participants who sampled Stonewall Participants who sampled Ariva Participants who sampled General Snus
All-Cause Mortality
Camel Snus Marlboro Snus Stonewall Ariva General Snus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Camel Snus Marlboro Snus Stonewall Ariva General Snus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/98 (0.00%)      0/98 (0.00%)      0/98 (0.00%)      0/98 (0.00%)      0/98 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Camel Snus Marlboro Snus Stonewall Ariva General Snus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/98 (9.18%)      5/98 (5.10%)      9/98 (9.18%)      5/98 (5.10%)      23/98 (23.47%)    
General disorders           
Dry Mouth *  1/98 (1.02%)  1 2/98 (2.04%)  2 3/98 (3.06%)  3 1/98 (1.02%)  1 0/98 (0.00%)  0
Excessive Salivation *  6/98 (6.12%)  6 2/98 (2.04%)  2 1/98 (1.02%)  1 2/98 (2.04%)  2 14/98 (14.29%)  14
Dizziness/Lightheadedness   0/98 (0.00%)  0 0/98 (0.00%)  0 3/98 (3.06%)  3 1/98 (1.02%)  1 3/98 (3.06%)  3
Sore Throat *  2/98 (2.04%)  2 1/98 (1.02%)  1 2/98 (2.04%)  2 1/98 (1.02%)  1 6/98 (6.12%)  6
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dorothy Hatsukami, Ph.D.
Organization: University_of_Minnesota
Phone: 612-626-2121
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00711100     History of Changes
Other Study ID Numbers: Study 1
1R01CA135884 ( U.S. NIH Grant/Contract )
First Submitted: July 2, 2008
First Posted: July 8, 2008
Results First Submitted: October 17, 2013
Results First Posted: September 16, 2015
Last Update Posted: May 12, 2017