CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 303 enrolled
Drug / intervention
NicoDerm Patch +1 moredrug
Likely dose
NicoDerm Patch 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/NCT01622998
NCT01622998Phase 4Completed

Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit

Ottawa Heart Institute Research Corporation·interventional·Posted Jun 19, 2012·Updated Mar 10, 2022

In Brief

A Phase 4 clinical trial evaluating NicoDerm Patch and Nicorette Inhaler for Smoking Cessation. Completed, enrolled 303 participants across 1 site.

Detailed Summary

The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves long-term rates of smoking cessation in patients motivated to quit smoking when compared to patients using the standard transdermal NRT patch protocol. The following hypothesis will be tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be higher for the titrated, self-directed NRT group compared to the standard NRT treatment group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2012
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.0 years ago

Interventions

NicoDerm Patchdrug

Dosage: 21mg patch; 14mg patch; 7 mg patch Frequency: NRT patch application once per day Duration: 10 week treatment period \*Titration for experimental group (NRT+) based on smoking history, and option to increase dose if withdrawal symptoms are unmanageable.

Nicorette Inhalerdrug

Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day