Condition category
Mental and Behavioural Disorders
Date applied
08/06/2006
Date assigned
11/09/2006
Last edited
18/10/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert West

ORCID ID

Contact details

Department of Epidemiology and Public Health
University College London
2-16 Torrington Place
London
WC1E 6BT
United Kingdom
robert.west@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0501300

Study information

Scientific title

Acronym

TAbex Smoking Cessation (TASC) trial

Study hypothesis

The study aims to determine the efficacy of a standard course of Tabex (cytisine) in aiding attempts to stop smoking.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Smoking cessation

Intervention

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’.

Intervention type

Drug

Phase

Not Specified

Drug names

Tabex (Cytisine)

Primary outcome measures

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 measures

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

Overall trial start date

01/02/2007

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

740 divided equally into active and placebo groups

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Poland

Trial participating centre

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Joint UCLH/UCL Biomedical Research and Development (R&D) Unit
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 5DB
United Kingdom
a.j.evans@ucl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Prevention Research Initiative (NPRI) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21991893

Publication citations

  1. Results

    West R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J, Aveyard P, Stapleton J, Placebo-controlled trial of cytisine for smoking cessation., N. Engl. J. Med., 2011, 365, 13, 1193-1200, doi: 10.1056/NEJMoa1102035.

Additional files

Editorial Notes