Smoking Reduction or Cessation With Nicotine Replacement Therapy
1 other identifier
interventional
314
1 country
2
Brief Summary
The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 1999
Shorter than P25 for phase_3
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
Study Start
First participant enrolled
February 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedApril 25, 2012
April 1, 2012
1.2 years
February 9, 2009
April 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Baseline to 6 weeks, 3 and 4 months
Secondary Outcomes (2)
Changes in laboratory values of cardiovascular risk factors
Baseline up to 12 months
Changes in clinical and laboratory exposure parameters
Baseline up to 12 months
Study Arms (4)
Nicotine gum
EXPERIMENTALNicotine gum
Placebo gum
PLACEBO COMPARATORPlacebo gum
Nicotine inhaler
ACTIVE COMPARATORNicotine inhaler
Placebo inhaler
PLACEBO COMPARATORPlacebo inhaler
Interventions
6-12 cartridges per day, maximum 12 daily
Eligibility Criteria
You may qualify if:
- Age above 18
- Smoking \>/= 15 cigarettes/day
- Having smoked for 3 years or more
- Want to reduce smoking
- Prepared to adhere to the protocol
- Willing to provide signed informed consent
- Having made at least one serious attempt to quit smoking
You may not qualify if:
- Unstable angina pectoris, myocardial infarction within the last three months
- Use of other nicotine-containing products such as cigars, pipes, snuff
- Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
- Pregnancy/lactation or intended pregnancy
- Under psychiatric care or medication that might interfere with the trial
- Abuse of alcohol or any other drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil ABlead
Study Sites (2)
Smoking Cessation Clinic
Kutná Hora, CZ-28430, Czechia
Institute of Hygiene and Epidemiology
Prague, CR-12800, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elisabeth Kruse, PhD
McNeil AB
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
February 1, 1999
Primary Completion
May 1, 2000
Study Completion
May 1, 2000
Last Updated
April 25, 2012
Record last verified: 2012-04