Conditions: Tobacco Use Disorder
Keywords: Oral Tobacco Products Snus Smoking Substitution Harm Reduction Biomarkers of Tobacco Exposure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 391
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Oral tobacco intervention 2: Nicotine Gum
Intervention descriptions: intervention 1: Snus intervention 2: 4 mg Nicotine gum

Protocol document: