Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
NCT00977249
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Long-term, daily NRT users (except nicotine patch) (>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
- More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
- more than 10 puffs of nasal spray per day.
- Age < 18 years,
- CO Smokers,
- Pregnant and lactating women,
- Used varenicline before,
- Not able to cooperate,
- Other significant diseases that might influence the trial (such as moderate -severe
cardiac disease, lung cancer,) in expired air > 7 ppm.
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Descriptive Information | ||||
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Brief Title ICMJE | Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users | |||
Official Title ICMJE | Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial | |||
Brief Summary | Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop? Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams. | |||
Detailed Description | 100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT. Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Tobacco Dependence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Tønnesen P, Mikkelsen K. Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Nicotine Tob Res. 2013 Feb;15(2):419-27. doi: 10.1093/ntr/nts146. Epub 2012 Sep 27. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE | 200 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2011 | |||
Estimated Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00977249 | |||
Other Study ID Numbers ICMJE | EudraCTnumber 2008-006426-24 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Chief Physician Philip Tønnesen, M.D., Gentofte University Hospital | |||
Study Sponsor ICMJE | University Hospital, Gentofte, Copenhagen | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | University Hospital, Gentofte, Copenhagen | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |