Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier:
NCT00882375
First received: April 15, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Smoking Cessation
Drug: Nicotine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm. [ Time Frame: at weeks 2, 6, 24 and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm. [ Time Frame: weeks 2, 4, 8, 12, 16, and 20 ] [ Designated as safety issue: No ]
  • Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm. [ Time Frame: weeks 4, 6, 8, 12, 16, 20, 24, and 52 ] [ Designated as safety issue: No ]
  • Ratings of craving/urge to smoke and withdrawal symptoms. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Cotinine levels in saliva. [ Time Frame: baseline, and weeks 2, 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Product acceptability [ Time Frame: weeks 1, 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 479
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine
Nicotine
Drug: Nicotine
Nicotine administered using novel NRT user instructions
Other Name: NRT
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo administered using novel NRT user instructions
Other Name: Placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882375

Locations
Denmark
Gentofte University Hospital
Hellerup, Denmark, 2900
Germany
University of Heidelberg
Mannheim, Germany, 68159
University Hospital of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
McNeil AB
Investigators
Study Director: Elisabeth Kruse, PhD McNeil AB
  More Information

No publications provided by Johnson & Johnson Consumer and Personal Products Worldwide

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00882375     History of Changes
Other Study ID Numbers: A6431111, 2008-006845-13
Study First Received: April 15, 2009
Last Updated: June 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
Smoking Cessation

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

ClinicalTrials.gov processed this record on August 28, 2014