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
2 other identifiers
interventional
258
1 country
2
Brief Summary
Pilot study of a new nicotine replacement therapy for smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJuly 10, 2012
July 1, 2012
2 months
October 1, 2008
July 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Mean hourly and daily number of doses used
throughout study
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORStandard NRT user direction
2
EXPERIMENTALNovel NRT user direction
Interventions
Nicotine replacement therapy with Standard NRT user direction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (2)
Department of Primary Care and General Practice, University of Birmingham
Birmingham, B15 2TT, United Kingdom
Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry
London, E1 2AD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
Global Medical Affairs & Clinical Research, McNeil AB, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 2, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 10, 2012
Record last verified: 2012-07