None listed
Conditions
Brief summary
This study aims to test whether a pulmonary nicotine inhaler plus nicotine patches can increase 6 month quit rates compared to nicotine patches plus placebo inhaler. Subjects receive 5 months of nicotine patch therapy, 6 months of nicotine inhaler therapy. Subjects reduce their smoking during the first month, after which they stop smoking completely. Quit rates are measured by self report 1 day, and 1, 3, and 6 months after the target quit date. Abstinence is verified by carbon monoxide measurements at 1 month after the target quit date.
Interventions
Nicotine pressurized metered-dose inhaler (pMDI) for 6 months plus nicotine transdermal patch for 5 months. The pMDI is a typical cannister, commonly used to deliver asthma medication. Cannisters come in 2 different doses: 100mcg, and 200mcg per puff of nicotine. Participants carry inhalers to use as needed. the nicotine patch dose will be titrated according to how many cigarettes each subjects smokes per day, as per the manufacturer's instruction - either 21,14,or7mg. During the 5th month subje
Nicotine pressurized metered-dose inhaler (pMDI) for 6 months plus nicotine transdermal patch for 5 months. The pMDI is a typical cannister, commonly used to deliver asthma medication. Cannisters come in 2 different doses: 100mcg, and 200mcg per puff of nicotine. Participants carry inhalers to use as needed. the nicotine patch dose will be titrated according to how many cigarettes each subjects smokes per day, as per the manufacturer's instruction - either 21,14,or7mg. During the 5th month subjects reduce by one dose step at a time over the month, so they have stopped at the end of the month. The inhaler and patches start on the same day - at Visit 1. The quit date is the date smoking ceased at the end of the four week smoking reduction phase.
Sponsors
Health Research Council
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 9 or more cigarettes per day, with a Fagerstom Test for Nicotine Dependence of 3 or more.
Exclusion criteria
Any serious medical condition, cardiovascular disease, alcohol abuse, allergy to nicotine patches, pregnancy, breastfeeding, inadequate contraception.
Outcome results
None listed