None listed
Conditions
Brief 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.
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 patc
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.
Sponsors
Health Research Council of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Smokers of 15 or more cigarettes per day, with Fagerstrom Test of Nicotine Dependence score of 3 or greater.
Exclusion criteria
Any serious medical condition, history of peptic ulcer, cardiovascular disease, pregnancy, breastfeeding, inadequate contraception.
Outcome results
None listed