drugset / Trial / NCT00710034

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

NCT00710034

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-04
Primary completion
2013-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nicotine Unknown 4 mg

Indications