Pilot Study of a New Nicotine Replacement Therapy

Smoking Cessation Clinical Trial

Official title:

Pilot Study on Usage Patterns of a Novel Nicotine Replacement Therapy - A Multi-Center, Open, 3-Week Randomized Low Intervention Study of Two Different Directions for Use in Smokers Motivated to Quit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764439
• Other study ID #: NICTDP2010
• Secondary ID: 2008-002498-11
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2008
• Last updated: July 6, 2012
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine replacement therapy
Nicotine replacement therapy with Standard NRT user direction
• Nicotine replacement therapy
Nicotine replacement therapy with a Novel NRT user direction

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean hourly and daily number of doses used		throughout study	No
Secondary	Mean number of NRT use occasions per day		Week 1, 2, and 3	No
Secondary	Ratings of craving/urge to smoke and withdrawal symptoms		Day 1-14, and Day 20	No
Secondary	Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm		Day 1-21	No
Secondary	Cotinine levels		At baseline and week 3	No
Secondary	Product acceptability		At week 3 visit	No
Secondary	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)	No