icoNovum Evaluation of Withdrawal Relief Study Part 1
- Conditions
- SmokersMental Health - Addiction
- Registration Number
- ACTRN12606000489594
- Lead Sponsor
- Professor Peter Hajek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 36
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method