Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 months
Drug: varenicline
|
| Placebo Comparator: placebo Placebo for 12 weeks |
Behavioral: support and visits
visits at weeks 0,2,4,6,9 and 12 and 12 months
Drug: placebo
|
Outcome Measures
Primary Outcome Measures
- 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 [12 weeks +/- 1 week]
Secondary Outcome Measures
- 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 [12 months +/- 3 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gentofte Hospital | Copenhagen | Hellerup | Denmark | 2900 |
Sponsors and Collaborators
- University Hospital, Gentofte, Copenhagen
- Pfizer
Investigators
- Principal Investigator: Philip Tønnesen, M.D., Gentofte Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EudraCTnumber 2008-006426-24