Pilot Study of a New Nicotine Replacement Therapy

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Nicotine replacement therapy

• Registration Number: NCT00764439
• Lead Sponsor: McNeil AB

Brief Summary

Pilot study of a new nicotine replacement therapy for smoking cessation.

Detailed Description

This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Nicotine replacement therapy	Novel NRT user direction
1	Nicotine replacement therapy	Standard NRT user direction

Primary Outcome Measures

Name	Time	Method
Mean hourly and daily number of doses used	throughout study

Secondary Outcome Measures

Name	Time	Method
Mean number of NRT use occasions per day	Week 1, 2, and 3
Ratings of craving/urge to smoke and withdrawal symptoms	Day 1-14, and Day 20
Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm	Day 1-21
Cotinine levels	At baseline and week 3
Product acceptability	At week 3 visit
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product.	throughout duration of the study (+ 30 days for spontaneous SAEs)

Trial Locations

Locations (2)

Department of Primary Care and General Practice, University of Birmingham; 🇬🇧 Birmingham, United Kingdom

Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry; 🇬🇧 London, United Kingdom