Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
|ClinicalTrials.gov Identifier: NCT00977249|
Recruitment Status : Unknown
Verified September 2009 by University Hospital, Gentofte, Copenhagen.
Recruitment status was: Recruiting
First Posted : September 15, 2009
Last Update Posted : September 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Behavioral: support and visits Drug: varenicline Drug: placebo||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
Active Comparator: varenicline
Varenicline for 12 weeks.
The treatment schedule for varenicline is:
Varenicline tablets, 0.5 mg x 1 daily, day 1-3 Varenicline 0.5 mg x 2, day 4-6 Varenicline 1 mg x 2, day 7 up to 12 weeks
Behavioral: support and visits
visits at weeks 0,2,4,6,9 and 12 and 12 monthsDrug: varenicline
Placebo Comparator: placebo
Placebo for 12 weeks
Behavioral: support and visits
visits at weeks 0,2,4,6,9 and 12 and 12 monthsDrug: placebo
- Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml [ Time Frame: 12 weeks +/- 1 week ]
- is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml [ Time Frame: 12 months +/- 3 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977249
|Contact: Philip Tønnesen, M.D:||+firstname.lastname@example.org|
|Contact: Helle Johnson, reg. nurse||+4539773512|
|Copenhagen, Hellerup, Denmark, 2900|
|Contact: Helle Johnson, reg Nures +4539773512|
|Contact: Helle Johnson, reg.nures|
|Principal Investigator: Philip Tønnesen, M.D|
|Principal Investigator:||Philip Tønnesen, M.D.||Gentofte Hospital|