None listed
Conditions
Brief summary
The primary purpose of this study is to test the acceptability of snus, compared to nicotine pouch (the pouch is like a sachet), compared to nicotine gum, and the degree to which each of these products reduces the number of cigarettes that people smoke. The hypothesis is that people will find snus and the nicotine pouch more acceptable than nicotine gum, and that the snus and the nicotine pouch will result in a larger reduction in number of cigarettes smoked per day than is acheived using nicotine gum. We have no hypothesis about the relative accepability or smoking reduction effectiveness of snus compared to nicotine pouch.
Interventions
Cross-over trial of 2 weeks of snus (1g of tobacco which contains 5mg of nicotine) ad lib (the frequency of administration is left up to each individual to decide so that each person can tailor the dose to his or her individual nicotine addiction) placed under upper lip, 2 weeks of novel nicotine pouch (4mg nicotine in a sachet) ad lib placed under upper lip, and 2 weeks of nicotine gum (4mg nicotine). The washout period is the first week of each two week arm of the trial in the sense that we wi
Cross-over trial of 2 weeks of snus (1g of tobacco which contains 5mg of nicotine) ad lib (the frequency of administration is left up to each individual to decide so that each person can tailor the dose to his or her individual nicotine addiction) placed under upper lip, 2 weeks of novel nicotine pouch (4mg nicotine in a sachet) ad lib placed under upper lip, and 2 weeks of nicotine gum (4mg nicotine). The washout period is the first week of each two week arm of the trial in the sense that we will discard the diary entries from the first week of each arm, and only analyse the diary entries of product use and cigarette smoking from the second week. This approach has been taken to help participants develop a routine of keeping a daily diary.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
People who smoke ten or more cigarettes per day.
Exclusion criteria
Use of bupropion (Zyban) or other nicotine replacement therapies in the previous 3 months. Any history of cardiovascular disease, or psychiatric disease..
Outcome results
None listed