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

Lead Research Organisation: University College London
Department Name: Epidemiology and Public Health

Abstract

Promoting smoking cessation is probably the single most important goal in reducing cancer. There are several drugs that can help, and psychological support is also effective. There is an opportunity to evaluate a drug (Tabex) that has been in use in Eastern Europe for many years, is generic and cheap to manufacture ? so much so that it costs less than one fifth of current medications. This would be of considerable benefit to UK smokers, the NHS and perhaps more importantly to low income smokers overseas. The proposed rigorous trial would be conducted in Poland and would represent exceptional value for money.

The findings will be taken forward through discussion with the MHRA and other relevant regulatory bodies to establish a basis for licensing. The results will also be dissemintated through appropriate press offices once a paper has been punlished in an appropriate peer review journal.

Technical Summary

This is a placebo-controlled RCT of Tabex (cytisine) as an aid to smoking cessation. Tabex currently has a licence as a stop smoking medication in some countries in Eastern Europe and has undergone Phase I, Phase II studies and clinical trials. However, the clinical evidence is not sufficient to permit firm conclusions to be made about efficacy or for a licence to be granted in countires such as the UK or US. A recent uncontrolled study in Poland found 12-month continuous abstinence rates, verified by expired air CO, of 18% with minimal behavioural support. This compares favourably with success rates using nicotine replacement therapy. Tabex is very inexpensive and offers the prospect of a treatment costing a small fraction of that currently available. 720 smokers of 10 or more cigarettes per day who are not contra-indicated for the medication would receive Tabex or matching placebo. The primary outcome measure would be 6-months? continuous abstinence verified by expired-air CO.

Publications

10 25 50
 
Description The effect of cytisine and a multimodal digitally facilitated behavioural intervention delivered in secondary care for cancer patients: a randomised factorial trial.
Amount $200,000 (USD)
Organisation Pfizer Ltd 
Sector Private
Country United Kingdom
Start 02/2018 
End 01/2020
 
Title TASC database 
Description Clinical trial data 
Type Of Material Database/Collection of Data/Biological Samples 
Provided To Others? No  
Impact Data likely to be of value to drug regulators or pharmaceutical industry 
 
Description MRC Cambridge 
Organisation Medical Research Council (MRC)
Department MRC Human Nutrition Research Group
Country United Kingdom 
Sector Academic/University 
PI Contribution The research team has taken the lead in designing and getting the trial up and running. We also manage the trial on a daily basis and are responsible for publication and dissemination of results.
Collaborator Contribution Professor Susan Jebb provides intellectual input for the trial; she has done so from the planning stages and continues to provide support to the trial. She brings expertise surrounding weight management in primary care. The collaboration with the MRC unit ended in 2013 due to Prof Susan Jebb taking up a position at University of Oxford.
Impact The output is the trial.
Start Year 2010
 
Description Primary Care Research Network (PCRN) 
Organisation National Institute for Health Research
Department School for Primary Care Research
Country United Kingdom 
Sector Academic/University 
PI Contribution The research is designed to improve knowledge of optimum stop smoking interventions and so will hopefully benefit the NHS.
Collaborator Contribution The primary care research network provide support for research in three ways: 1) Providing participating GP surgeries with Service Support Costs to compensate them for taking part in the research 2) Helping to recruit GP practices to take part 3) Providing nursing time to run the study
Impact Aided practice and participant recruitment in the rapid reduction trial.
Start Year 2008
 
Description RCGP 
Organisation Royal College of General Practitioners
Country United Kingdom 
Sector Academic/University 
PI Contribution The research team has taken the lead in designing and getting the trial up and running. We also manage the trial on a daily basis and are responsible for publication and dissemination of results.
Collaborator Contribution Dr Rachel Pryke from RCGP assisted with the training materials for the GPs. She is the obesity champion for the RCGP.
Impact The training material for the GPs is the output of this collaboration.
Start Year 2012
 
Description Rosemary Conley 
Organisation Rosemary Conley Diet and Fitness Clubs
Country United Kingdom 
Sector Private 
PI Contribution The research team has taken the lead in designing and getting the trial up and running. We also manage the trial on a daily basis and are responsible for publication and dissemination of results.
Collaborator Contribution Rosemary Conley have provided support for the treatment costs of the trial and some of their class providers have offered to give classes for free to our participants.
Impact There are no outputs yet.
Start Year 2011
 
Description Slimming World 
Organisation Slimming World
Department Research Development
Country United Kingdom 
Sector Private 
PI Contribution The research team has taken the lead in designing and getting the trial up and running. We also manage the trial on a daily basis and are responsible for publication and dissemination of results.
Collaborator Contribution Slimming world offered to cover the treatment costs for the trial and provided, for free, the vouchers for our participants to attend Slimming World.
Impact There are no outputs yet.
Start Year 2010
 
Description UCL-Warsaw 
Organisation Polish Ministry of Health
Department The Maria Sklodowska-Curie Institute of Oncology
Country Poland 
Sector Academic/University 
PI Contribution Design, management or clinical trial
Collaborator Contribution Treatment of clinical trial participants
Impact Published paper in NEJM.
Start Year 2006
 
Description University of Birmingham 
Organisation University of Birmingham
Department Department of Primary Care Clinical Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution The research team has taken the lead in designing and getting the trial up and running. We also manage the trial on a daily basis and are responsible for publication and dissemination of results.
Collaborator Contribution Dr Amanda Farley, Dr Amanda Daley, Prof Kate Jolly And Dr Peymane Adab all contributed to this trial from the planning stages and continue to provide support to the trial in a number of capacities, such as intellectual input and trial support.
Impact The outcome from this partnership is the trial itself.
Start Year 2010
 
Title Tabex 
Description Cytisine is a very inexpensive medication for smoking cessation. Following this trial it has been put forward for regulatory approval in a number of countries. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2011
Development Status Under active development/distribution
Clinical Trial? Yes
Impact Following this trial it has been put forward for regulatory approval in a number of countries. 
URL http://www.isrctn.com/ISRCTN37568749
 
Description A blog in the Conversation 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact A post-doctoral researcher in the team wrote a blog in the Conversation about cytisine and the failure of the world to take this clearly effective medication and make it widely available.
Year(s) Of Engagement Activity 2016
 
Description DH 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Policymakers/politicians
Results and Impact Meetings with DH civil servants and ministers

Ongoing considerations of trial results
Year(s) Of Engagement Activity 2011