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Health Effects of SLT, Cigarette Smoking, and New Tobacco Products (ANTS3)

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: NCT00469079
Recruitment Status : Completed
First Posted : May 4, 2007
Results First Posted : April 14, 2014
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nicotine Dependence
Interventions Drug: Nicotine gum and lozenge
Other: Taboka
Other: Camel Snus
Enrollment 130
Recruitment Details Healthy smokers were recruited from the Twin Cities, MN metro area from November of 2006 through October of 2008.
Pre-assignment Details  
Arm/Group Title Assigned to NRT Assigned to Taboka Assigned to Camel Snus
Hide Arm/Group Description Nicotine gum or nicotine lozenge Taboka - oral tobacco product Camel Snus - oral tobacco product
Period Title: Overall Study
Started 27 52 51
Completed 18 30 32
Not Completed 9 22 19
Reason Not Completed
Lack of Efficacy             3             8             5
Adverse Event             1             3             2
Lost to Follow-up             4             8             10
Withdrawal by Subject             1             2             2
Ineligible             0             1             0
Arm/Group Title Assigned to NRT Assigned to Taboka Assigned to Camel Snus Total
Hide Arm/Group Description Nicotine gum or nicotine lozenge Taboka - oral tobacco product Camel Snus - oral tobacco product Total of all reporting groups
Overall Number of Baseline Participants 27 52 51 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 52 participants 51 participants 130 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
52
 100.0%
51
 100.0%
130
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 52 participants 51 participants 130 participants
42.4  (12.8) 42.4  (11.2) 43.6  (11.5) 42.8  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 52 participants 51 participants 130 participants
Female
12
  44.4%
21
  40.4%
20
  39.2%
53
  40.8%
Male
15
  55.6%
31
  59.6%
31
  60.8%
77
  59.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 52 participants 51 participants 130 participants
27 52 51 130
Fagerstrom Test for Nicotine Dependence Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 27 participants 52 participants 51 participants 130 participants
5.2  (1.2) 3.8  (1.1) 4.4  (1.6) 4.5  (1.3)
[1]
Measure Description: Fagerstrom Test for Nicotine Dependence. Minimum value is 0 and maximum value is 10. Higher scores indicate greater dependence.
1.Primary Outcome
Title Toxicant Exposure by Products
Hide Description Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.
Time Frame Baseline, 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who continued in the protocol were analyzed. Non-parametric Kruskal-Wallis method of analysis was used.
Arm/Group Title Medicinal Nicotine Taboka Snus
Hide Arm/Group Description:
4 mg nicotine gum or nicotine lozenge
Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
Overall Number of Participants Analyzed 19 30 33
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/ml
Cotinine
835.3
(351.5 to 1984.9)
782.1
(414.5 to 1475.6)
726.8
(333.7 to 1582.8)
Total NNAL
0.157
(0.096 to 0.255)
0.281
(0.182 to 0.435)
0.296
(0.191 to 0.458)
Total NNN
0.010
(0.003 to 0.034)
0.011
(0.004 to 0.027)
0.026
(0.012 to 0.057)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medicinal Nicotine, Taboka, Snus
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Product Use at Week 4 of Intervention
Hide Description Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed intervention.
Arm/Group Title Medicinal Nicotine Taboka Snus
Hide Arm/Group Description:
4 mg nicotine gum or lozenge
A spitless, oral tobacco pouch.
A spitless, oral tobacco pouch.
Overall Number of Participants Analyzed 18 30 32
Least Squares Mean (Standard Error)
Unit of Measure: uses per day
7.27  (0.55) 5.27  (0.42) 6.76  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medicinal Nicotine, Taboka, Snus
Comments Product use is by self-report and daily diaries.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.
Hide Description This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (<35 ng/mL).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat model.
Arm/Group Title Medicinal Nicotine Taboka Camel Snus
Hide Arm/Group Description:
Nicotine gum or nicotine lozenge
Taboka - oral tobacco product
Camel Snus - oral tobacco product
Overall Number of Participants Analyzed 27 52 51
Measure Type: Number
Unit of Measure: participants
End of intervention continuous abstinence 11 17 22
1 week post-intervention point prevalence 15 22 24
11 weeks post intervention point prevalence 9 12 16
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medicinal Nicotine, Taboka, Camel Snus
Comments This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.
Method of Estimation Estimation Parameter Other
Estimated Value 0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.
Hide Description Changes in craving and withdrawal symptoms were assessed at the time of discontinuation of usual brand cigarettes (i.e., baseline compared to week 1). Assessments were made using the Minnesota Nicotine Withdrawal Scale, which measures abstinence effects from usual brand cigarettes. Total Score: Range of scores is from 0 to 28. All items with the exclusion of craving are summed. Craving Score: Range of score is from 0 to 4. A higher score would indicate more severe withdrawal.
Time Frame Baseline and 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects completing the intervention
Arm/Group Title Medicinal Nicotine Taboka Snus
Hide Arm/Group Description:
4 mg nicotine gum or lozenge
A spitless, oral tobacco pouch.
A spitless, oral tobacco pouch.
Overall Number of Participants Analyzed 18 30 32
Mean (Standard Error)
Unit of Measure: units on a scale
Craving Scores 2.55  (0.18) 2.76  (0.14) 2.62  (0.13)
Nicotine Withdrawal Scores 8.15  (1.17) 8.89  (0.86) 8.61  (0.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Medicinal Nicotine, Taboka, Snus
Comments A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean difference between 3 groups
Estimated Value 0
Estimation Comments [Not Specified]
Time Frame Adverse events were collected during 4 weeks on study product.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Assigned to NRT Assigned to Taboka Assigned to Camel Snus
Hide Arm/Group Description Nicotine gum or nicotine lozenge Taboka - oral tobacco product Camel Snus - oral tobacco product
All-Cause Mortality
Assigned to NRT Assigned to Taboka Assigned to Camel Snus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Assigned to NRT Assigned to Taboka Assigned to Camel Snus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/52 (0.00%)      0/51 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Assigned to NRT Assigned to Taboka Assigned to Camel Snus
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/27 (66.67%)      28/52 (53.85%)      39/51 (76.47%)    
Ear and labyrinth disorders       
Dizziness   1/27 (3.70%)  1 6/52 (11.54%)  6 2/51 (3.92%)  2
Gastrointestinal disorders       
Nausea   2/27 (7.41%)  2 10/52 (19.23%)  14 6/51 (11.76%)  11
Stomach Aches   5/27 (18.52%)  6 5/52 (9.62%)  7 11/51 (21.57%)  14
Constipation   2/27 (7.41%)  2 3/52 (5.77%)  3 2/51 (3.92%)  2
Diarrhea   3/27 (11.11%)  3 1/52 (1.92%)  1 5/51 (9.80%)  7
General disorders       
Dry Mouth   4/27 (14.81%)  6 11/52 (21.15%)  16 13/27 (48.15%)  27
Headaches   6/27 (22.22%)  10 8/52 (15.38%)  8 7/51 (13.73%)  10
Lightheadedness   2/27 (7.41%)  2 5/52 (9.62%)  5 2/51 (3.92%)  2
Sore Jaw or Jaw Pain   4/27 (14.81%)  7 1/52 (1.92%)  1 3/51 (5.88%)  4
Shakiness   1/27 (3.70%)  1 5/52 (9.62%)  6 1/51 (1.96%)  2
Hiccups   3/27 (11.11%)  7 3/52 (5.77%)  4 20/51 (39.22%)  35
Sore Throat   6/27 (22.22%)  8 3/52 (5.77%)  3 5/51 (9.80%)  10
Sleep Disturbance   8/27 (29.63%)  9 10/52 (19.23%)  12 11/51 (21.57%)  14
Excessive Salivation   4/27 (14.81%)  11 7/52 (13.46%)  9 15/51 (29.41%)  30
Skin and subcutaneous tissue disorders       
Mouth Sores   4/27 (14.81%)  4 6/52 (11.54%)  7 16/51 (31.37%)  27
Indicates events were collected by systematic assessment
Smokeless tobacco products commercially available have been introduced, withdrawn, or changed at a relatively rapid rate resulting in products that are no longer available and changes that occurred during the time period that the study occurred.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dorothy Hatsukami, Ph.D.
Organization: University of Minnesota
Phone: 612-626-2121
EMail: hatsu001@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00469079    
Other Study ID Numbers: 010M79961
P50DA013333 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2007
First Posted: May 4, 2007
Results First Submitted: October 29, 2013
Results First Posted: April 14, 2014
Last Update Posted: November 1, 2019