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Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

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ClinicalTrials.gov Identifier: NCT00710034
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : December 6, 2017
Last Update Posted : December 6, 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: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Other: Oral tobacco
Drug: Nicotine Gum

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Cigarette smokers interested in completely switching to snus or nicotine gum were recruited from Minneapolis/St Paul, Minnesota, and Eugene, Oregon.

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
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus


Participant Flow for 2 periods

Period 1:   Completed 6 Weeks of Treatment
    Nicotine Gum   Snus
STARTED   195   196 
COMPLETED   154 [1]   149 [2] 
NOT COMPLETED   41   47 
Adverse Event                5                12 
Lack of Efficacy                12                8 
Lost to Follow-up                15                17 
Product dissatisfaction                2                6 
Withdrawal by Subject                6                4 
Physician Decision                1                0 
[1] Completed 6 weeks of treatment for primary outcome assessment: N=154
[2] Completed 6 weeks of treatment for primary outcome assessment: N=149

Period 2:   Completed 12 Weeks of Treatment
    Nicotine Gum   Snus
STARTED   154   149 
COMPLETED   141   138 
NOT COMPLETED   13   11 
Adverse Event                0                1 
Lack of Efficacy                0                2 
Lost to Follow-up                5                5 
Product Dissatisfaction                0                1 
Withdrawal by Subject                8                2 



  Baseline Characteristics

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
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus

Total Total of all reporting groups

Baseline Measures
   Nicotine Gum   Snus   Total 
Overall Participants Analyzed 
[Units: Participants]
 195   196   391 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      195 100.0%      196 100.0%      391 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.9  (12.5)   43.2  (12.5)   43.9  (12.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      95  48.7%      89  45.4%      184  47.1% 
Male      100  51.3%      107  54.6%      207  52.9% 
Region of Enrollment 
[Units: Participants]
     
United States   195   196   391 


  Outcome Measures

1.  Primary:   Product Effect on Complete Substitution for Smoking   [ Time Frame: 6 week post smoking substitution ]

Measure Type Primary
Measure Title Product Effect on Complete Substitution for Smoking
Measure Description Number of subjects using only the assigned study product at week 6
Time Frame 6 week post smoking substitution  

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
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus


Measured Values
   Nicotine Gum   Snus 
Participants Analyzed   153   149 
Product Effect on Complete Substitution for Smoking 
[Units: Participants]
 56   56 

No statistical analysis provided for Product Effect on Complete Substitution for Smoking



2.  Primary:   Number of Cigarettes Smoked   [ Time Frame: 6 weeks post cigarette substitution ]

Measure Type Primary
Measure Title Number of Cigarettes Smoked
Measure Description Cigarettes per day at mid intervention
Time Frame 6 weeks post cigarette substitution  

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
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus


Measured Values
   Nicotine Gum   Snus 
Participants Analyzed   149   154 
Number of Cigarettes Smoked 
[Units: Cigarettes per day]
Mean (Standard Deviation)
 18.6  (33.8)   18.8  (28.5) 

No statistical analysis provided for Number of Cigarettes Smoked



3.  Primary:   Number of Products Used   [ Time Frame: 6 weeks post smoking substitution ]

Measure Type Primary
Measure Title Number of Products Used
Measure Description Pieces of product per week at mid intervention
Time Frame 6 weeks post smoking substitution  

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
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus


Measured Values
   Nicotine Gum   Snus 
Participants Analyzed   149   154 
Number of Products Used 
[Units: Pieces per week]
Mean (Standard Deviation)
 37.6  (26.3)   39.1  (24.0) 

No statistical analysis provided for Number of Products Used



4.  Secondary:   Products Effect on Withdrawal Symptoms.   [ Time Frame: Week 1-12 post switching ]

Measure Type Secondary
Measure Title Products Effect on Withdrawal Symptoms.
Measure Description Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.
Time Frame Week 1-12 post switching  

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.
Using assigned product only. The numbers of subjects that were only using the assigned product were 40 and 37 for nicotine gum and oral tobacco respectively at week 12. Analysis was conducted from weeks 1-12 post-switching.

Reporting Groups
  Description
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus


Measured Values
   Nicotine Gum   Snus 
Participants Analyzed   40   37 
Products Effect on Withdrawal Symptoms. 
[Units: Units on a scale]
Mean (Standard Deviation)
   
Baseline Scores   4.17  (5.01)   5.01  (5.14) 
Week 12 Scores   5.57  (6.05)   5.73  (6.24) 

No statistical analysis provided for Products Effect on Withdrawal Symptoms.



5.  Secondary:   Product Effect on Biomarkers of Exposure and Toxicity   [ Time Frame: Baseline and Week 4 post smoking substitution ]

Measure Type Secondary
Measure Title Product Effect on Biomarkers of Exposure and Toxicity
Measure Description Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).
Time Frame Baseline and Week 4 post smoking substitution  

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
Nicotine Gum

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Snus

Oral tobacco

Oral tobacco: Snus


Measured Values
   Nicotine Gum   Snus 
Participants Analyzed   58   52 
Product Effect on Biomarkers of Exposure and Toxicity 
[Units: Pmol//mg creatinine]
Mean (Standard Deviation)
   
Baseline   1.39  (1.04)   1.28  (0.94) 
Week 4   0.30  (0.39)   1.34  (1.55) 

No statistical analysis provided for Product Effect on Biomarkers of Exposure and Toxicity




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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
e-mail: hatsu001@umn.edu


Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00710034     History of Changes
Other Study ID Numbers: 1R01 CA135884-2
1R01CA135884 ( U.S. NIH Grant/Contract )
First Submitted: July 2, 2008
First Posted: July 3, 2008
Results First Submitted: November 30, 2016
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017