CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Nicoderm CQ transdermal nicotine +1 moredrug
Likely dose
Nicoderm CQ transdermal nicotine 21mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00956943
NCT00956943Phase 2Completed

Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine

University of Pennsylvania·interventional·Posted Aug 11, 2009·Updated Aug 15, 2014

In Brief

A Phase 2 clinical trial evaluating Nicoderm CQ transdermal nicotine and placebo for Nicotine Dependence. Completed, enrolled 87 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2009
Enrollment StartAug 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.9 years ago

Interventions

Nicoderm CQ transdermal nicotinedrug

Transdermal nicotine patch (21mg vs. 42mg), 8 weeks

placebodrug

placebo patch