Randomised controlled trial of Zonnic and nicotine patch (ZAP) in smoking cessation
Randomised placebo-controlled trial of Zonnic and nicotine patch in heavy smokers for smoking cessation
Health Research Council of New Zealand
1,600 participants
Mar 12, 2010
Interventional
Conditions
Summary
We aim to test the effect on 12 month quit rates of adding Zonnic (a nicotine mouthspray) to nicotine patch therapy compared to nicotine patch therapy plus placebo Zonnic. Subjects will receive 5 months of nicotine patch, and 6 months of Zonnic. Subjects will reduce their smoking in the first month, then quit smoking and continue to use Zonnic and patches. Abstinence will be measured at 12 months post-cessationo and verified by plasma or hair nicotine.
Eligibility
Inclusion Criteria1
- Smokers of 15 or more cigarettes per day, with Fagerstrom Test of Nicotine Dependence score of 3 or greater.
Exclusion Criteria1
- Any serious medical condition, history of peptic ulcer, cardiovascular disease, pregnancy, breastfeeding, inadequate contraception.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Zonnic (peppermit flavoured nicotine mouthspray) plus nicotine patch compared to placebo-Zonnic plus active nicotine patch. Zonnic for 6 months, nicotine patch for 5 months. Zonnic contains 1mg nicotine per spray, use at the discretion of the participant for first 5 months, wean during 6th month. Use patches daily with dose titrated to amount smoked using standard schedule recommended by manufacturer. In 5th month wean from patches in step-wise manner as laid out by manufacturer. Zonnic and patches both start at the second clinic visit. Quit date is the first quit day at the end of the 3 weeks of smoking reduction.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12609000482268