Smoking cessation Mental and Behavioural Disorders Smoking cessation
Conditions
Interventions
Smokers wanting to stop will be individually randomised to receive a course of Tabex (cytisine) for 25 days or a matched placebo. The dosage will be as currently licensed in Poland:
1. One tablet (1.
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Smokers of ten or more cigarettes per day willing to attempt to stop smoking permanently 2. Willing to attend all the sessions 3. Able to read and write Polish and provide informed consent 4. Able to be contacted by telephone 5. Participants must agree not to use any other smoking cessation medications or tobacco products during the study, at least until the point where they have relapsed and will be regarded as a treatment failure.
Exclusion criteria
Exclusion criteria: 1. Participants must not be undergoing treatment for any psychological disorder or medical conditions that contraindicate cytisine as listed on the data sheet (including diagnosed arterial hypertension or acute cardiovascular disease) 2. Not pregnant or breastfeeding 3. Not planning on becoming pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be self-report of abstinence from smoking or use of any tobacco products from two weeks after the quit date for twelve months with no more than five cigarettes in total during that time, confirmed by an expired air Carbon Monoxide (CO) reading at the twelve month follow-up of less than 10 ppm. Inclusion will be by intent to treat and all subjects whose smoking status cannot be determined but who are not known to have moved to an untraceable address or died will be counted as smokers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/11/2010: 1. Continuous abstinence from two weeks after the quit date with no more than five cigarettes smoked in total up to six months, together with a CO of less than 10 ppm at the 6 month follow-up 2. Self-reported continuous abstinence with no cigarettes smoked during the first four weeks of treatment, supported by CO verification at the end-of-treatment session. 3. The severity of withdrawal symptoms measured using the Mood and Physical Symptoms Scale, one week after the designated quit date in smokers who have been abstinent since the quit date 4. Minor and serious adverse events reported throughout the trial 5. Depression, mood and physical symptoms reported throughout the trial. Previous secondary outcome measures: 1. Self-reported continuous abstinence with no cigarettes smoked for weeks three and four supported by CO verification at week four 2. Continuous abstinence with no more than five cigarettes smoked in total up to 12-months, together with a CO of less than 10 ppm at the 12-month follow-up 3. The severity of withdrawal symptoms measured using the Mood and Physical Symptoms Scale, one week after the designated quit date in smokers who have been abstinent since the quit date | — |
Countries
Poland
Outcome results
None listed