drugset / Trial / NCT00956943

Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine

NCT00956943

Phase 2 Completed 87 enrolled University of Pennsylvania
RandomizedFactorialTriple-blindTreatment

Summary

Unfortunately, the investigators still need to assess and identify novel ways to help people quit smoking. Differences between people in terms of how fast they metabolize nicotine influences response to transdermal nicotine patches, the most popular nicotine dependence treatment, and it affects plasma levels of nicotine from treatment. These studies suggest that fast metabolizers of nicotine may show better quit rates if they receive higher doses of transdermal nicotine. This preliminary study is designed to assess, for the first time, whether fast nicotine metabolizers show higher quit rates if given high dose transdermal nicotine, versus standard dose. The study findings may help to support a subsequent large trial to assess standard versus high dose transdermal nicotine for slow versus fast metabolizers of nicotine, which may lead to a more personalized approach to treating nicotine dependence using the nicotine patch to improve therapeutic benefits of transdermal nicotine.

Timeline

Start
2009-08
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 21 mg Other
Subject Nicotine Unknown 42 mg Other

Indications