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| [ Print-friendly version ] |
| The effect of Tabex (Cytisine) on success of attempts to stop smoking |
| ISRCTN | ISRCTN37568749 |
| DOI | 10.1186/ISRCTN37568749 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The effect of Tabex (Cytisine) on success of attempts to stop smoking |
| Scientific title | |
| Acronym | TAbex Smoking Cessation (TASC) trial |
| Serial number at source | G0501300 |
| Study hypothesis | The study aims to determine the efficacy of a standard course of Tabex (cytisine) in aiding attempts to stop smoking. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Approval obtained in the UK: University College London Ethics Committee, approved on 13/12/2006 (ref: 0498/003).
Approvals obtained in Poland: 1. Ethics Committee at the Cancer Centre and Institute of Oncology, approved on 09/01/2007, Ref: 02/2007 2. Central Register of Clinical Trials (CEBK), approved on 19/03/2007, Ref: 110/UR/CEBK/03/07 |
| Study design | Double blind placebo-controlled randomised trial with two arms |
| Countries of recruitment | Poland |
| Disease/condition/study domain | Smoking cessation |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 01/02/2007 |
| Anticipated end date | 31/03/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 740 divided equally into active and placebo groups |
| 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 (1.5mg) every two hours (six per day) for three days 2. One tablet every 2.5 hours (five per day) from days four to 12 3. One tablet every three hours (four per day) from days 13 to 16 4. One tablet every four hours (three per day) from days 17-20 5. One tablet every six hours (two tablets daily) from days 21 to 25. The total regimen involves 100 tablets. Smokers are instructed to stop smoking completely by the fifth day which is designated as the ‘quit date’. |
| Primary outcome measure(s) | 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 outcome measure(s) |
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 |
| Sources of funding | National Prevention Research Initiative (NPRI) (UK) |
| Trial website | |
| Publications | 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21991893 |
| Contact name | Prof Robert West |
| Address |
Department of Epidemiology and Public Health
University College London 2-16 Torrington Place |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| robert.west@ucl.ac.uk | |
| Sponsor | University College London (UK) |
| Address |
Joint UCLH/UCL Biomedical Research and Development (R&D) Unit
Ground Floor, Rosenheim Wing 25 Grafton Way |
| City/town | London |
| Zip/Postcode | WC1E 5DB |
| Country | United Kingdom |
| a.j.evans@ucl.ac.uk | |
| Date applied | 08/06/2006 |
| Last edited | 18/10/2011 |
| Date ISRCTN assigned | 11/09/2006 |
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