MedTrace Logo

Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation

NCT01622998 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2022-03-10

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

NicoDerm Patch

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.

DRUG

Nicorette Inhaler

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

Sponsors & Collaborators

  • Heart and Stroke Foundation of Ontario

    collaborator OTHER

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Andrew Pipe, CM, MD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622998 on ClinicalTrials.gov