Testing the feasibility of nicotine assisted reduction to stop in pharmacies. The RedPharm Study

Lead Research Organisation: University of Birmingham
Department Name: Health and Population Sciences

Abstract

Nicotine assisted reduction to stop means treating smokers who do not want to stop smoking but are prepared to reduce smoking with nicotine replacement therapy. Trials in highly controlled circumstances showed this increased smoking cessation, but there are doubts about whether this can be implemented in health systems. We propose a trial to examine whether pharmacists who provide stop smoking services can integrate a reduction service into their practice and develop methods for use in a subsequent trial. This subsequent trial will investigate whether behavioural support is more effective than no support and whether shorter reduction programmes are more effective.

Technical Summary

Harm reduction in nicotine addiction means providing treatments such as nicotine replacement therapy to smokers who cannot or do not want to quit with the aim of reducing the harm they suffer from continued smoking. The least controversial step would be to provide NRT to smokers who are prepared to reduce smoking and provide advice on how to reduce with a view to one day quitting. A systematic review and meta-analysis and cost-effectiveness analysis shows that such a strategy is effective and cost-effective but it is not currently recommended in either British or US smoking cessation guidelines because of uncertainty as to how this fits with current practice. We propose a pilot randomised trial to examine whether pharmacists can be trained to implement NARS, how well they do so, and how this is received by smokers and by pharmacists. These pharmacists will be selected from those providing NHS stop smoking support. We will use this to prepare for a future definitive factorial trial of short versus standard reduction and behavioural support versus no support. About 160 participants will be randomised to test the acceptability, take up, adherence, and feasibility of trial follow up procedures. We propose using minimal contact procedures initially by email to monitor process and outcome of the trial and qualitative interviews with trial therapists and participants to examine how they integrated reduction programmes into their brief interventions and cessation work and how this is understood by participants. This would assess some of the barriers precluding use of reduction programmes and prepare for a further trial to assess the effectiveness of behavioural support and length of programme.
 
Description Advice to DH
Geographic Reach National 
Policy Influence Type Participation in a national consultation
Impact I consulted with Department of Health on smoking reduction in 2010 and 2011. This led to the development of Routes to Quit, which introduced smoking reduction programmes into the NHS Stop Smoking Service. The policy was introduced into the last tobacco control policy of the Labour Government and the Coalition Government affirmed this.
 
Description Development of routes to quit
Geographic Reach National 
Policy Influence Type Citation in other policy documents
Impact The change is the policy of allowing flexible introduction of routes to quit. This means that people who cannot stop smoking abruptly are offered support by the NHS to do so by cutting down first. Our systematic review showed that this was unexpectedly as effective as abrupt cessation and this led to the change in policy.
URL https://www.gov.uk/government/publications/guidance-for-providing-and-monitoring-stop-smoking-servic...
 
Description NICE harm reduction committee
Geographic Reach National 
Policy Influence Type Membership of a guidance committee
Impact Our review was cited in the evidence that led NICE to recommend introducing harm reduction strategies for smoking cessation in the NHS. I was a member of the NICE harm reduction group that drafted the guidance
URL https://www.nice.org.uk/guidance/ph45
 
Description A multi-centre Trial of physical Activity assisted Reduction of Smoking (TARS).
Amount £55,917 (GBP)
Funding ID 15/111 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 09/2017 
End 08/2020
 
Description A randomised controlled trial on the effectiveness of GP promotion of e-cigarettes in supporting reduced smoking and abstinence in hardcore smokers with smoking-related chronic disease (ERASE).
Amount £301,580 (GBP)
Funding ID PDF-2016-09-043 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 11/2016 
End 10/2019
 
Description A randomised controlled trial on the effectiveness of GP promotion of e-cigarettes in supporting reduced smoking and abstinence in hardcore smokers with smoking-related chronic disease (ERASE).
Amount £398,766 (GBP)
Funding ID PDF-2016-09-043 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 11/2016 
End 10/2019
 
Description An exploratory trial to evaluate the effects of a physical activity intervention as a smoking cessation induction and cessation aid among the 'hard to reach'
Amount £432,368 (GBP)
Funding ID 07/78/02 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 09/2009 
End 08/2012
 
Description Health Technology Assessment clinical trials
Amount £432,368 (GBP)
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 09/2009 
End 08/2012
 
Description Health Technology Assessment trials competition
Amount £2,189,845 (GBP)
Funding ID HTA 09/110/01 
Organisation National Institute for Health Research 
Department Health Technology Assessment Programme (HTA)
Sector Public
Country United Kingdom
Start 03/2012 
End 08/2016
 
Description Heart of Birmingham Primary Care Trust
Amount £194,000 (GBP)
Organisation Heart Of Birmingham Teaching Primary Care Trust (PCT) 
Department Whittle Street Clinic
Sector Public
Country United Kingdom
Start 06/2010 
End 03/2013
 
Description Perceptions of GPs and nurses on the role of e-cigarettes for harm reduction and smoking cessation in general practice
Amount £25,218 (GBP)
Funding ID A23875 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 02/2017 
End 07/2017
 
Description UKCRC centres of excellence in public health research
Amount £4,000,000 (GBP)
Funding ID RES-590-28-0004 
Organisation Economic and Social Research Council 
Sector Public
Country United Kingdom
Start 06/2008 
End 05/2013
 
Description Understanding the nature and drivers of dual use of electronic and tobacco cigarettes.
Amount £47,139 (GBP)
Funding ID 23880 
Organisation Cancer Research UK 
Sector Charity/Non Profit
Country United Kingdom
Start 11/2017 
End 02/2019
 
Description Heart of Birmingham PCT 
Organisation Birmingham Heartlands Hospital
Country United Kingdom 
Sector Hospitals 
PI Contribution We are working with Heart of Birmingham PCT to reach what they term hard to reach smokers to improve public health. We are doing this through the interventions in our trials
Collaborator Contribution Working with the PCT to help train pharmacists
Impact None as yet
Start Year 2010
 
Title Smoking reduction schedules 
Description We have developed smoking reduction interventions and supporting tools 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2010
Development Status Under active development/distribution
Impact Not yet evaluated 
 
Description Plenary lecture at a CPD event for smoking cessation services 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Health professionals
Results and Impact My PhD student got to give a plenary lecture to an audience of about 500 delegates at a national training conference

The talk was well received. It helped lay the groundwork for changes in policy for the NHS Stop Smoking Services to introduce smoking reduction programmes, like the one investigated in our trial.
Year(s) Of Engagement Activity 2010
 
Description Press conference for NICE harm reduction guidance 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Widely picked up in the press with national newspaper, TV, and radio slots

The guidance has had a large impact on the perception of people about the approach to tobacco
Year(s) Of Engagement Activity 2013
 
Description Workshop on smoking reduction 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Health professionals
Results and Impact 60 participants attended a workshop to learn detailed methods of behavioural approach to smoking reduction

We made our materials available on the web and they formed the basis of NHS smoking reduction programmes
Year(s) Of Engagement Activity 2010