ASCEND: A Study of Cessation using Electronic Nicotine Devices
- Conditions
- Smoking CessationPublic Health - EpidemiologyMental Health - Addiction
- Registration Number
- ACTRN12610000866000
- Lead Sponsor
- Health Research Council NZ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 653
1. Participants will be smokers from throughout Auckland
who want to stop smoking.
2. Are at least 18 years of age,
3. Have smoked on average at least 10 cigarettes a day for the past year
4. Are able to provide verbal consent
5. Have access to a phone
1. Pregnant women and women who are breastfeeding will be excluded from the trial,
2. Current users of another smoking cessation medication ((e.g. other forms of NRT, buproprion [Zyban], clonidine, nortriptyline [Norpress] or vareniciline [Champix])
3. Those enrolled in another smoking cessation programme (e.g. Txt2Quit) or trial.
4. Had a heart attack, stroke or severe angina in the previous two weeks
5. Poorly controlled asthma or other airways disease (from history
6. Poorly controlled diabetes mellitus
7. Severe allergies
8. Poorly controlled psychiatric disorders
9. Current chemical dependence other than that involving nicotine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Continuous abstinence from smoking for six months after the quit day using the Russell Standard definition of abstinence (i.e. intention to treat analysis, biochemical verification of self-reported abstinence using an exhaled carbon monoxide (CO) measurement of <10 parts per million).[6 months post Quitday]
- Secondary Outcome Measures
Name Time Method Continuous abstinence assessed at one and three months: The proportion of participants that have stopped smoking, defined as self-report of smoking not more than five cigarettes from the Quit date.[One and three months];7-day point prevalence assessed: The proportion of participants that have stopped smoking, defined as self-report of having smoked no cigarettes (not even a puff) in the past seven days[1 week, 1 month, 3 months and 6 months post Quitday];Number of cigarettes smoked per day: If the participant is still smoking, all time points.[1 week, 1 month, 3 months and 6 months post Quitday];The physical signs and symptoms associated with withdrawal: Measured using the AUTOS.[1 week, 1 month, 3 months and 6 months post Quitday]