Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Placebo; Drug: Nicotine

• Registration Number: NCT00882375
• Lead Sponsor: McNeil AB

Brief Summary

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

Detailed Description

Efficacy and safety study following use of a novel nicotine replacement therapy.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

Inclusion Criteria

• 18 years or older male and female cigarette smokers motivated and willing to stop smoking
• Female participants of child-bearing potential should use a medically acceptable means of birth control.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion Criteria

• Unstable angina pectoris or myocardial infarction during the previous 3 months.
• Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
• Participation in other clinical trials within the previous three months and during study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Nicotine	Nicotine	Nicotine

Primary Outcome Measures

Name	Time	Method
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.	at weeks 2, 6, 24 and 52

Secondary Outcome Measures

Name	Time	Method
Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.	weeks 2, 4, 8, 12, 16, and 20
Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.	weeks 4, 6, 8, 12, 16, 20, 24, and 52
Ratings of craving/urge to smoke and withdrawal symptoms.	baseline to 24 weeks
Cotinine levels in saliva.	baseline, and weeks 2, 6, 12 and 24
Product acceptability	weeks 1, 6 and 12

Trial Locations

Locations (3)

Gentofte University Hospital; 🇩🇰 Hellerup, Denmark

University of Heidelberg; 🇩🇪 Mannheim, Germany

University Hospital of Tuebingen; 🇩🇪 Tuebingen, Germany