Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
|ClinicalTrials.gov Identifier: NCT00710034|
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.
For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Disorder||Other: Oral tobacco Drug: Nicotine Gum||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This was an open label trial.|
|Official Title:||Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking|
|Study Start Date :||April 2010|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2014|
Active Comparator: Nicotine Gum
Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
Drug: Nicotine Gum
4 mg Nicotine gum
Other Name: Nicorette
Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
Other: Oral tobacco
Other Name: Camel Snus
- Product Effect on Complete Substitution for Smoking [ Time Frame: 6 week post smoking substitution ]Number of subjects using only the assigned study product at week 6
- Number of Cigarettes Smoked [ Time Frame: 6 weeks post cigarette substitution ]Cigarettes per day at mid intervention
- Number of Products Used [ Time Frame: 6 weeks post smoking substitution ]Pieces of product per week at mid intervention
- Products Effect on Withdrawal Symptoms. [ Time Frame: Week 1-12 post switching ]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.
- Product Effect on Biomarkers of Exposure and Toxicity [ Time Frame: Baseline and Week 4 post smoking substitution ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710034
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|United States, Oregon|
|Oregon Research Institute|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Dorothy Hatsukami, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|