Pilot Study of a New Nicotine Replacement Therapy

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine replacement therapy; Drug: Nicotine replacement therapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2TT
    • Department of Primary Care and General Practice, University of Birmingham
  • London, United Kingdom, E1 2AD
    • Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Standard NRT user direction	Drug: Nicotine replacement therapy; Nicotine replacement therapy with Standard NRT user direction; Other Names: NRT; Drug: Nicotine replacement therapy; Nicotine replacement therapy with a Novel NRT user direction; Other Names: NRT
Experimental: 2; Novel NRT user direction	Drug: Nicotine replacement therapy; Nicotine replacement therapy with Standard NRT user direction; Other Names: NRT; Drug: Nicotine replacement therapy; Nicotine replacement therapy with a Novel NRT user direction; Other Names: NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean hourly and daily number of doses used	throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: McNeil AB
• Investigators: Study Director: Elisabeth Kruse, PhD, Global Medical Affairs & Clinical Research, McNeil AB, Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICTDP2010; 2008-002498-11 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No