Study Stopped
Study terminated due to a technical issue (randomization error).
Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week Trial to Measure the Efficacy and Safety of a Novel Nicotine Replacement Therapy in Smokers in a Naturalistic Environment
1 other identifier
interventional
257
1 country
19
Brief Summary
This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home. Approximately 1500 subjects will be enrolled into the study. The study will require participants to use the treatment for 12 weeks and there will be a 14-week follow-up period. The study will be conducted in approximately 20 pharmacies across the United States. At the first visit to the pharmacy, participants will be asked some questions to see if they are eligible to participate. Participants will be asked to sign a consent form if they agree to participate. Participants will answer some more questions, and blow into a machine to measure their carbon monoxide (CO) levels to make sure they qualify for the trial. Participants will be asked to go to a nearby dentist who will look at their mouths. Participants will go back to the pharmacy and if they qualify, they will be given a supply of their assigned treatment. They will have an equal chance of receiving a treatment that has a drug in it or one that has no drug in it. They will be given a diary to keep track of how much of the treatment they use. Subjects will go to the pharmacy four more times to hand in their diaries and blow into a machine that will measure their CO levels. At the last visit, subjects will have their mouths examined by a dentist again to have their mouth checked. Subjects will receive four telephone calls during the study where they will be asked some questions. After the 12 week treatment period, subjects will receive two to three more telephone calls, where they will be asked to answer some questions. Participants may be asked to come back to the pharmacy two more times to blow into the carbon monoxide machine again.
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 Mar 2011
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
April 23, 2012
CompletedApril 23, 2012
March 1, 2012
1 month
February 14, 2011
March 29, 2012
March 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Continuous Smoking Abstinence
Number of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking from Week 2 through Week 6.
through Week 6
Secondary Outcomes (23)
Number of Participants With Continuous Smoking Abstinence
through Week 26
Number of Participants With 7-day Point Prevalence Abstinence
through Week 26
Mean Number of Daily Doses
Week 1
Mean Number of Daily Doses
Week 2
Mean Number of Daily Doses
Week 3
- +18 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR0 mg Oral NRT, up to 4 times per hour for 12 weeks
Nicotine
EXPERIMENTAL1 mg Oral NRT, up to 4 times per hour for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must be males or females 18 years of age or older who currently smoke cigarettes and are willing to stop smoking
You may not qualify if:
- Subjects must not have a recent history of unstable angina, myocardial infarction or stroke
- They must not have a suspected malignant and/or erosive oral lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.lead
- McNeil ABcollaborator
- GlaxoSmithKlinecollaborator
Study Sites (19)
Avalon Discount Drugs
Muscle Shoals, Alabama, 35661, United States
Coast Compounding Pharmacy
Oceanside, California, 92054, United States
Wynn's Pharmacy, Inc.
Griffin, Georgia, 30224, United States
Stark Pharmacy
Overland Park, Kansas, 64116, United States
Goodrich Pharmacy
Anoka, Minnesota, 55303, United States
Goodrich Pharmacy
Elk River, Minnesota, 55330, United States
Goodrich Pharmacy
Saint Francis, Minnesota, 55070, United States
Cub Pharmacy #1924
Saint Louis Park, Minnesota, 55426, United States
Medicap Pharmacy
Clarksdale, Mississippi, 38614, United States
Liddy's Health Mart
Holly Springs, Mississippi, 38635, United States
Countryside Pharmacy
Savannah, Missouri, 64485, United States
Phil's Pills
Albuquerque, New Mexico, 87110, United States
Kerr Drug
Raleigh, North Carolina, 27609, United States
Family Prescription Center
Bethlehem, Pennsylvania, 18015, United States
T.B. Bond Pharmacy
Hillsboro, Texas, 76645, United States
Inwood Pharmacy
Houston, Texas, 77070, United States
Louis Morgan Drug #1
Longview, Texas, 75602, United States
Brick Street Pharmacy
Tyler, Texas, 75701, United States
Montpelier Pharmacy, Inc.
Montpelier, Virginia, 23192, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Summary tabulations are not available for the primary and some secondary outcome measures because the study was terminated early due to a technical issue (randomization error).
Results Point of Contact
- Title
- Joyce Hauze, RPS Sr. Specialist, Clinical Research Operations
- Organization
- Johnson & Johnson Consumer and Personal Products Worldwide
Study Officials
- STUDY DIRECTOR
Daniel Qi, MD
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
April 23, 2012
Results First Posted
April 23, 2012
Record last verified: 2012-03