ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

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: 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
Enrollment 391

Recruitment Details Cigarette smokers interested in completely switching to snus or nicotine gum were recruited from Minneapolis/St Paul, Minnesota, and Eugene, Oregon.
Pre-assignment Details  
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Period Title: Completed 6 Weeks of Treatment
Started 195 196
Completed 154 [1] 149 [2]
Not Completed 41 47
Reason Not Completed
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 Title: Completed 12 Weeks of Treatment
Started 154 149
Completed 141 138
Not Completed 13 11
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             0             2
Lost to Follow-up             5             5
Product Dissatisfaction             0             1
Withdrawal by Subject             8             2
Arm/Group Title Nicotine Gum Snus Total
Hide Arm/Group Description

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Total of all reporting groups
Overall Number of Baseline Participants 195 196 391
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 196 participants 391 participants
43.9  (12.5) 43.2  (12.5) 43.9  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 196 participants 391 participants
Female
95
  48.7%
89
  45.4%
184
  47.1%
Male
100
  51.3%
107
  54.6%
207
  52.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 195 participants 196 participants 391 participants
195 196 391
1.Primary Outcome
Title Product Effect on Complete Substitution for Smoking
Hide Description Number of subjects using only the assigned study product at week 6
Time Frame 6 week post smoking substitution
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description:

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Overall Number of Participants Analyzed 153 149
Measure Type: Number
Unit of Measure: participants
56 56
2.Primary Outcome
Title Number of Cigarettes Smoked
Hide Description Cigarettes per day at mid intervention
Time Frame 6 weeks post cigarette substitution
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description:

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Overall Number of Participants Analyzed 149 154
Mean (Standard Deviation)
Unit of Measure: cigarettes per day
18.6  (33.8) 18.8  (28.5)
3.Primary Outcome
Title Number of Products Used
Hide Description Pieces of product per week at mid intervention
Time Frame 6 weeks post smoking substitution
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description:

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Overall Number of Participants Analyzed 149 154
Mean (Standard Deviation)
Unit of Measure: Pieces per week
37.6  (26.3) 39.1  (24.0)
4.Secondary Outcome
Title Products Effect on Withdrawal Symptoms.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description:

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Overall Number of Participants Analyzed 40 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Scores 4.17  (5.01) 5.01  (5.14)
Week 12 Scores 5.57  (6.05) 5.73  (6.24)
5.Secondary Outcome
Title Product Effect on Biomarkers of Exposure and Toxicity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description:

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

Overall Number of Participants Analyzed 58 52
Mean (Standard Deviation)
Unit of Measure: pmol//mg creatinine
Baseline 1.39  (1.04) 1.28  (0.94)
Week 4 0.30  (0.39) 1.34  (1.55)
Time Frame Subjects were provided study product for 12 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nicotine Gum Snus
Hide Arm/Group Description

Nicotine replacement therapy

Nicotine Gum: 4 mg Nicotine gum

Oral tobacco

Oral tobacco: Snus

All-Cause Mortality
Nicotine Gum Snus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nicotine Gum Snus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/195 (0.51%)      1/196 (0.51%)    
Musculoskeletal and connective tissue disorders     
Death  [1]  1/195 (0.51%)  1 0/196 (0.00%)  0
Psychiatric disorders     
Hospitalization  [2]  0/195 (0.00%)  0 1/196 (0.51%)  1
Indicates events were collected by systematic assessment
[1]
Subject was diagnosed with leiomyosarcoma at week 6 in the study.
[2]
Hospitalization due to suicidal ideation.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nicotine Gum Snus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/195 (0.00%)      0/196 (0.00%)    
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: 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