Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 08/31/2009 |
| První předloženo: | 09/13/2009 |
| Odhadovaná registrace vložena: | 09/13/2009 |
| První zveřejnění: | 09/14/2009 |
| Poslední aktualizace byla odeslána: | 09/13/2009 |
| Poslední aktualizace zveřejněna: | 09/14/2009 |
| Aktuální datum zahájení studie: | 08/31/2009 |
| Odhadované datum dokončení primární: | 11/30/2011 |
| Odhadované datum dokončení studie: | 11/30/2011 |
Stav nebo nemoc
Intervence / léčba
Behavioral: support and visits
Drug: varenicline
Drug: placebo
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| 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 | Drug: varenicline |
| Placebo Comparator: placebo Placebo for 12 weeks | Drug: placebo |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 18 Years Na 18 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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. |
Výsledek
Primární výsledná opatření
1. 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]
Měření sekundárních výsledků
1. 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]
