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Pilot Study of a New 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:
NCT00764439
First received: October 1, 2008
Last updated: July 6, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Smoking Cessation
 Drug: Nicotine replacement therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Mean hourly and daily number of doses used [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean number of NRT use occasions per day [ Time Frame: Week 1, 2, and 3 ] [ Designated as safety issue: No ]
  • Ratings of craving/urge to smoke and withdrawal symptoms [ Time Frame: Day 1-14, and Day 20 ] [ Designated as safety issue: No ]
  • Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm [ Time Frame: Day 1-21 ] [ Designated as safety issue: No ]
  • Cotinine levels [ Time Frame: At baseline and week 3 ] [ Designated as safety issue: No ]
  • Product acceptability [ Time Frame: At week 3 visit ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

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

No publications provided

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
ClinicalTrials.gov Identifier: NCT00764439     History of Changes
Other Study ID Numbers: NICTDP2010, 2008-002498-11
Study First Received: October 1, 2008
Last Updated: July 6, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013