None listed
Conditions
Brief summary
The study has been designed to test how effectively and rapidly a number of new nicotine replacement treatments - nicotine oral pouch, mouthspray and lozenge - relieve the discomfort that people experience when they stop smoking (called withdrawal symptoms) compared to a currently available nicotine replacement product (nicotine gum) and a “dummy” (placebo) product (with no nicotine in it). These new products may deliver nicotine to the body faster than existing products, and it is thought that faster delivery of nicotine may help reduce the discomfort that goes along with stopping smoking. The study will also ask about the level of satisfaction people experience after using the different products.
Interventions
Part 1 Test Products: Niconovum nicotine oral pouch (4mg)
Mode of administration: place under upper lip
Sponsors
Professor Peter Hajek
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Smoke =15 cigarettes per day for the last year Smoke within 30 minutes of wakingSelf-report being in good health with verification by medical historyBe able to attend the study site for 4 weeks on the same day of the week. Be able to read and write EnglishParticipants are capable of giving informed consent.
Exclusion criteria
Recent (within 6 months) myocardial infarction, angina pectoris, or other serious medical condition Diabetes mellitus Previous severe allergic reactionCurrent chemical dependence other than nicotine Current psychiatric disorderChronic oral disorderPregnant (will have negative urinary dipstick for ßHCG)Breast feedingWeight less than 45 kg or over 120 kgUrine dipstick positive for glucoseBlood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolicCurrent use of nicotine products other than cigarettesAny condition that would preclude proper use of nicotine gumCurrent use of clonidine, buspirone, doxepin, bupropion, fluoxetine or other psychotropic drugParticipants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (CO verified)Participants who wish to stop smoking during the 4-week study period. Please note, for those who wish to cease smoking after the study, assistance (pharmacological treatment and behavioural support) will be provided).
Outcome results
None listed