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Pilot Study of a New Nicotine Replacement Therapy

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ClinicalTrials.gov Identifier: NCT00764439
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine replacement therapy Phase 2

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  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Standard NRT user direction
Drug: Nicotine replacement therapy
Nicotine replacement therapy with Standard NRT user direction
Other Name: NRT
Experimental: 2
Novel NRT user direction
Drug: Nicotine replacement therapy
Nicotine replacement therapy with a Novel NRT user direction
Other Name: NRT



Primary Outcome Measures :
  1. Mean hourly and daily number of doses used [ Time Frame: throughout study ]

Secondary Outcome Measures :
  1. Mean number of NRT use occasions per day [ Time Frame: Week 1, 2, and 3 ]
  2. Ratings of craving/urge to smoke and withdrawal symptoms [ Time Frame: Day 1-14, and Day 20 ]
  3. Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm [ Time Frame: Day 1-21 ]
  4. Cotinine levels [ Time Frame: At baseline and week 3 ]
  5. Product acceptability [ Time Frame: At week 3 visit ]
  6. 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. [ Time Frame: throughout duration of the study (+ 30 days for spontaneous SAEs) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764439


Locations
United Kingdom
Department of Primary Care and General Practice, University of Birmingham
Birmingham, United Kingdom, B15 2TT
Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry
London, United Kingdom, E1 2AD
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD Global Medical Affairs & Clinical Research, McNeil AB, Sweden

Responsible Party: McNeil AB
ClinicalTrials.gov Identifier: NCT00764439     History of Changes
Other Study ID Numbers: NICTDP2010
2008-002498-11 ( EudraCT Number )
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action