Smoking cessation: treating the intractable smoker
Submitting InstitutionQueen Mary, University of London
Unit of AssessmentClinical Medicine
Summary Impact TypeHealth
Research Subject Area(s)
Medical and Health Sciences: Public Health and Health Services
Psychology and Cognitive Sciences: Psychology
Summary of the impact
There is no `magic bullet' for helping intractable smokers to quit.
Rather, the story of this research is one of multiple studies that have
built the knowledge base incrementally, allowing Professor of Clinical
Psychology Peter Hajek and his team at the Wolfson Institute of
Preventative Medicine to produce a targeted, evidence-based model of a
specialist treatment that has fed directly into the establishment of the
NHS smoking cessation service (NHS-SSS) and national smoking cessation
policy (including NICE guidance), and changed clinical practice. The
NHS-SSS treats 800,000 smokers per year. The approach is influential
globally and has now been used in treating several million smokers and
preventing hundreds of thousands of premature deaths.
Despite falling rates in many countries, smoking remains one of the
biggest killers globally. It costs the NHS £1.5 billion a year. As smoking
becomes less socially acceptable, those who continue to smoke are a
self-selecting group for whom simple interventions such as brief advice
have repeatedly failed. Since 1993, Hajek's team, the Tobacco Dependence
Research Unit (TDRU), at Queen Mary have systematically researched
psychological and drug therapies for persistent smokers. Some studies
identified effective treatments now used worldwide; others had negative
findings, preventing costly but ineffective interventions being
Most smokers in the UK 50 years ago were 'social smokers' who were naïve
to health promotion and relatively easily influenced by brief
interventions. While some people still respond to brief advice (and this
remains a key intervention), many smokers today are nicotine dependent and
relatively intractable. A substantial proportion have mental health
problems, multi-morbidity and/or complex social circumstances. They may
require specialist services and active (pharmacological and intensive
behavioural) interventions — reflected in the emergence of the NHS-SSS in
The focus of Hajek's research has been on developing and testing new drug
treatments (including balancing the benefits of pharmacotherapies with
their potential harms); streamlining complex behavioural interventions so
they can be applied on a large scale, and developing and piloting a
treatment package that can be disseminated across the NHS.
Hajek joined Queen Mary in 1992, bringing along an early version of what
was then called the `Maudsley Model' of a specialist smoking cessation
intervention developed by himself and colleagues, and establishing the
TDRU. TDRU's work since 1992 has focused particularly on developing a
practicable treatment model suitable for nationwide dissemination and
undertaking randomised controlled trials, systematic reviews and
meta-analyses to inform practical provision of smoking cessation
treatments. Importantly, and almost by definition, no magic bullet exists
for helping intractable smokers to quit. However, significant findings
from the body of work at TDRU from 1993 to 2013 have extended the
knowledge base in this challenging area. Of a total of over 100 studies by
this Group in the past 20 years, we have selected ten key studies (note:
these are illustrative of the kind of work they are doing rather
than representing the totality of that work).
2a: Systematic reviews
The team have completed eight major and several smaller reviews, with
statistical meta-analyses where appropriate, some in collaboration with
the Cochrane Tobacco Addiction Review Group, and some commissioned by NICE
and DH. These helped inform UK and international public health policy and
the research agenda. They summarised and synthesised the evidence base on
the following questions:
- What is the efficacy of different approaches to preventing relapse
after smoking cessation? Main finding: neither skills training nor
extended treatment contact has a sufficiently strong evidence base for
routine use in smoking cessation clinics. Other potential approaches
were identified which are now pursued by proactive NHS and NIHR funding
initiatives (2009) .
- Are surgical outcomes worse if smokers quit shortly before elective
surgery? Main finding: no significant difference in surgical outcomes
between recent quitters and non-quitters (2011) .
- Do any alternative therapies not currently used by the NHS show
efficacy or a promise that they might be effective? Main findings:
Hypnosis, acupuncture, gradual cessation gadgets and several herbal
remedies lack efficacy. The `Alan Carr method' awaits evaluation.
- What is the efficacy of cytisine in smoking cessation? Main finding:
Cytisine is effective. Given its low cost and good safety profile, its
licensing should be expedited. (2013) 
- What is the relationship between an individual's rate of nicotine
metabolism and their risk of dependence, severity of withdrawal symptoms
and chance of successful quitting? Main finding: there is currently
limited evidence that individual variation in nicotine metabolism can be
used to tailor pharmacotherapy, but further studies are warranted.
- What is the efficacy and safety of aversive therapy (eg `rapid
smoking') as an aid to quitting? Main finding: primary studies were
positive but generally of poor quality and publication bias may have
occurred, hence the evidence base for this approach is weak.
- Are there any risks associated with nicotine withdrawal and use of
nicotine replacement treatments in secondary care and in pregnancy? Main
finding: NRT is safe in secondary care though its use in ICUs to prevent
delirium is not warranted. NRT is safer than smoking in pregnancy, but
with standard dosing and brief support, it lacks efficacy.
- What are the optimal treatment approaches for use in secondary care
and in pregnancy? Main finding: brief interventions with or without
medications are not effective, but treatments providing support for over
four weeks have good evidence of efficacy.
- What is the efficacy and safety of interventions to reduce
post-cessation weight gain? Main finding: whilst some pharmacotherapies
appear to have short-term success, these benefits are not reliably
sustained long term and significant side effects may occur. Dieting in
the initial period of cigarette withdrawal may undermine the quit
attempt (2012) .
2b: Randomised controlled trials (RCTs)
Hajek's team have published over 20 RCTs since 1993. Selected examples
- Brief interventions vs usual care during routine hospital admissions
to promote smoking cessation. Main finding: no advantage over usual
care. (2002) 
- Comparison of five different nicotine replacement therapy (NRT)
products. Main finding: current NRT products are equally effective and
have low abuse potential. (1999) 
- Efficacy of routine stop-smoking and relapse prevention interventions
in pregnancy versus usual care. Main finding: brief interventions lack
efficacy in this setting.
- Nicotine lozenge vs placebo in smoking cessation (pivotal trial). Main
finding: Nicotine lozenges are effective.
- Varenicline vs placebo used for 4 weeks prior to quitting. Main
finding: Varenicline pre-loading reduces enjoyment of smoking and smoke
intake and facilitates smoking cessation. (2011) 
- Combining varenicline with nicotine patch or placebo patch. Main
finding: Nicotine patch does not increase varenicline efficacy (2013)
- Efficacy of nicotine mouth spray vs nicotine lozenges. Main finding:
mouth spray was significantly better than lozenges at reducing urge to
- Efficacy of nicotine pouch vs placebo (pivotal trial). Nicotine pouch
- Ondansetron vs placebo in reducing withdrawal symptoms in smoking
cessation. Main finding: no advantage over placebo.
- Varenicline vs placebo as maintenance following successful abstinence
at 3 months (pivotal trial). Main finding: extended treatment improves
long-term outcomes. (2006) 
2c: Cohort studies (17 in total since 1993; below are examples
focusing on one research topic pioneered by Hajek's team: long-term use of
- Prevalence of long-term use of nicotine chewing gum among smokers
treated at routine services. Main finding: 6% use gum at one year,
primarily exceptionally heavy smokers who seem to need long-term help to
maintain abstinence, gum use reduces weight gain.
- Effect of NRT cost on long-term use. Main finding: making NRT free had
no major effect on the occurrence of their long-term use.
- Long-term use of different NRT products. Main finding: dependence
potential is proportional to the speed of nicotine delivery.
2d: Standardisation of outcome measures
On the basis of many years' experience summarising different primary
studies, Hajek's team proposed a standard set of outcome criteria to be
followed by all studies to make comparison and synthesis easier. The
standard is increasingly used by researchers worldwide (2005) .
This work was undertaken mainly by Hajek and his staff at TDRU. The main
external collaborator was Prof Robert West at UCL and other members of the
UK Centre of Tobacco Control Studies, Public Health Centre of Excellence,
of which TDRU is the key member researching treatments for dependent
smokers. Funding was from MRC, NIHR, NHS, charities and manufacturers of
stop-smoking medication. Researchers on the author lists below who were
working at Queen Mary at the time of the research include Hajek, McRobbie,
Burrows, Meadow, Taylor, Mills and Myers.
References to the research
1. Hajek P, Stead LF, West R, Jarvis M, Lancaster T. Relapse prevention
interventions for smoking cessation. Cochrane Database of Systematic
Reviews 2009; CD003999. doi: 10.1002/14651858.CD003999.pub3
2. Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before
surgery and postoperative complications: a systematic review and
meta-analysis. Archives of Internal Medicine 2011; 171: 983-989.
3. Hajek P, McRobbie H, Myers K. Efficacy of cytisine in helping smokers
quit: systematic review and meta-analysis. Thorax 2013; doi:
4. Farley AC, Hajek P, Lycett D, Aveyard P. Interventions for preventing
weight gain after smoking cessation. Cochrane Database of Systematic
Reviews 2012; CD006219. doi: 10.1002/14651858.CD006219.pub3
5. Hajek P, Taylor TZ, Mills P. Brief intervention during hospital
admission to help patients to give up smoking after myocardial infarction
and bypass surgery: randomised controlled trial. BMJ 2002; 324:
6. Hajek P, West R, Foulds J, Nilsson F, Burrows S, Meadow A. Randomized
comparative trial of nicotine polacrilex, a transdermal patch, nasal
spray, and an inhaler. Archives of Internal Medicine 1999; 159:
7. Hajek P, McRobbie H, Myers K, Dhanji A, Stapleton J. Use of
varenicline for four weeks before quitting smoking. Decrease in ad-lib
smoking and increase in smoking cessation rates. Archives of Internal
Medicine 2011; 171: 770-7.
8. Hajek P, Myers K, Dhanji A, McRobbie H. Is a combination of
varenicline and nicotine patch more effective in helping smokers quit than
varenicline alone? A randomised controlled trial. BMC Medicine
2013; 11:140 doi:10.1186/1741-7015-11-140.
9. Tonstad S, Tønesen P, Hajek P, Williams K, Billing C, Reeves K. Effect
of maintenance therapy with varenicline on smoking cessation: a randomized
controlled trial. JAMA 2006; 296: 64-71.
10. West, R., Hajek, P., Stead, L., & Stapleton, J. (2005). Outcome
criteria in smoking cessation trials: proposal for a common standard. Addiction
2005; 100: 299-303.
Details of the impact
4a: Reframing the paradigm of smoking cessation
One cumulative impact from 20 years of research at TDRU has been a shift
in professional (and, to a lesser extent, public) understanding of the
problem of persistent smoking. Doctors and others are now more likely to
acknowledge that giving up smoking is not a simple issue of willpower;
people who do not quit readily on brief advice are likely to have complex
physiological, cognitive or social circumstances that militate against
successful quitting. This paradigm shift was recognized in 2008 when the
official US guideline on tobacco control was updated: "Tobacco
dependence is a chronic disease that often requires repeated
intervention and multiple attempts to quit. Effective treatments exist,
however, that can significantly increase rates of long-term abstinence"
. The justification of this statement was argued in a parallel
editorial in the Annals of Internal Medicine .
4b: Improving treatments for dependent smokers
This research has contributed to advances in pharmacological and
behavioural treatments of dependent smokers used worldwide. For example:
pivotal trials contributed to the licensing approvals of nicotine lozenge,
varenicline (reference 8 above) and mouth spray; and the trial of
varenicline pre-loading (reference 7 above) is changing clinical practice
currently. The `Maudsley' Model of intensive stop-smoking treatment
refined and piloted within TDRU is now used across NHS-SSS and abroad.
More effective treatments of intractable smokers are contributing to the
reduction in smoking-related morbidity and mortality in this group.
Because tobacco dependence is closely linked to social disadvantage, this
is also contributing to reducing health inequalities.
4c: Clinical and policy clarity on what does not work
Some TDRU trials and reviews have shown negative or ambiguous results,
curtailing widespread implementation of ineffective interventions. For
example, the RCT of brief intervention in routine hospital admission
(reference 5 above) showed no significant improvement in quit rate. A
similar study showed negative impact of midwife-led advice in pregnant
women. The effect of these negative studies is that, increasingly, busy
clinicians are not expected to deliver smoking cessation efforts to
persistent smokers in settings where such interventions would be
4d: Change in NICE guidelines and other official advice
- Hakek was co-opted onto the Programme Development Group for the NICE
Public Health Guidance for smoking cessation (PH10). He undertook a
rapid review of non-NHS treatments for smoking cessation as part of the
guideline development process, incorporating the various reviews done by
TDRU and others . PH10 superseded previous NICE reviews of individual
therapies and aimed for the first time to review the totality of
- Hakek advised the guideline development group for Public Health
Guidance 34 Quitting Smoking in Pregnancy and Following Childbirth .
He wrote a 'Rapid review of interventions to prevent relapse in pregnant
ex-smokers', which was appended to the NICE guidance.
- The series of studies on long-term use of nicotine replacement
treatments (eg refs 10 and 11 above) were instrumental in relaxing NRT
licensing and allowing long-term NRT use. Prior to this research it was
believed that NRT should be prescribed only for short periods.
- Research from TDRU has influenced smoking cessation policy beyond the
UK. For example, the World Health Organisation Policy Recommendations
cites Hajek's research .
4d: Policy investment in specialised smoking cessation services
This work contributed to significant policy shift towards specialist
smoking cessation services. NHS-SSS, established in 1999, is unique
internationally as a support for smokers motivated to quit but unable to
do so unaided . The service provision framework employed by the smoking
cessation clinics was originally based on the Maudsley model developed by
Hajek et al and subsequently refined by him at QMUL in
collaboration with others. It consists of regular meetings (group or one
to one) with a trained adviser using structured, withdrawal-oriented
support with smoking cessation medications. The NHS-SSS, which treats
800,000 smokers annually, operates in dialogue with a number of specialist
teams, including TDRU, who continue to undertake studies whose findings
directly inform the refinement and extension of the clinical service.
Sources to corroborate the impact
- Treating Tobacco Use and Dependence: 2008 Update. U.S. Department of
Health and Human Services. Rockville (MD): Public Health Service; May
- Steinberg MB, Schmelzer AC, Richardson DL, Foulds J: The case for
treating tobacco dependence as a chronic disease. Annals of Internal
Medicine 2008; 148: 554-556.
- Fiore MC, Baker B. Should Clinicians Encourage Smoking Cessation for
Every Patient Who Smokes? Smoking Cessation for Every Patient Who
Smokes. JAMA 2013; 309: 1032-33.
- NICE Public Health Guidance 10. Smoking Cessation Services (2008).
- NICE Public Health Guidance 26. Quitting Smoking in Pregnancy and
Following Childbirth (2010). http://guidance.nice.org.uk/PH26/Guidance/pdf/English
- World Health Organization. Policy recommendations for smoking
cessation and treatment of tobacco dependence. Geneva: World Health
Organization (2003, still current).
- Bauld L, Bell K, McCullough L, Richardson L, Greaves L. The
effectiveness of NHS smoking cessation services: a systematic review. Journal
of Public Health 2010; 32: 71-82.
- Mardle T, Merrett S, Wright J, Percival F, Lockhart I. Real world
evaluation of three models of NHS Smoking Cessation Service in England.
BMC Research Notes 2012; 5: 9.