The effect of Tabex (Cytisine) on success of attempts to stop smoking

ISRCTN ISRCTN37568749
DOI https://doi.org/10.1186/ISRCTN37568749
Secondary identifying numbers G0501300
Submission date
08/06/2006
Registration date
11/09/2006
Last edited
18/10/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Robert West
Scientific

Department of Epidemiology and Public Health
University College London
2-16 Torrington Place
London
WC1E 6BT
United Kingdom

Email robert.west@ucl.ac.uk

Study information

Study designDouble blind placebo-controlled randomised trial with two arms
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymTAbex Smoking Cessation (TASC) trial
Study hypothesisThe study aims to determine the efficacy of a standard course of Tabex (cytisine) in aiding attempts to stop smoking.
Ethics approval(s)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
ConditionSmoking cessation
InterventionSmokers 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’.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Tabex (Cytisine)
Primary outcome measureThe 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 measuresCurrent 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
Overall study start date01/02/2007
Overall study end date31/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants740 divided equally into active and placebo groups
Participant inclusion criteria1. 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.
Participant exclusion criteria1. 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
Recruitment start date01/02/2007
Recruitment end date31/03/2009

Locations

Countries of recruitment

  • England
  • Poland
  • United Kingdom

Study participating centre

Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom

Sponsor information

University College London (UK)
University/education

Joint UCLH/UCL Biomedical Research and Development (R&D) Unit
Ground Floor, Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
England
United Kingdom

Email a.j.evans@ucl.ac.uk
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

National Prevention Research Initiative (NPRI) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 29/09/2011 Yes No