1. Smoking cessation and mental ill health:
what does trial based evidence tell us?
Dr Tim Bradshaw
Senior Lecturer
University of Manchester

2. Content
• Review issues related to mortality and
morbidity in people with serious mental illness
(SMI)
• Consider some of the reasons for poor
physical health including smoking
• Examine evidence for the effectiveness of
smoking cessation in people with SMI
• Present the Scimitar bespoke smoking
cessation in SMI trial

12. Life expectancy in people with SMI?
• People with SMI die on average 15 - 25 years earlier
than other members of general population
(Schizophrenia Commission, 2012, Tiihonen et al.,
2009)
• While most of the world’s population has enjoyed
increasing longevity people with SMI are dying at a
younger age than they were 30 years ago (Saha et al.
2007)

13. Reasons for poor physical health
• Poor diet (McCreadie, 2003)
• Low levels of physical activity (Brown et al, 1999)
• Approximately 70 – 80% of people with
schizophrenia are overweight or obese
(McCreadie, 2003)
• High prevalence of smoking (Kelly and
McCreadie, 1999)
• Effect of atypical neuroleptic medication (Sims,
1987; Mortenson and Juel, 1990; Appleby, 2000)

14. What proportion of people with SMI
smoke?
General
population

15. Smoking is not good for you
• Cancers
• Chromic lung disease
• IHD
• Osteoporosis
• Etc etc
• ‘Current cigarette smoking will cause 450
million deaths over the next 50 years’ Richard
Peto

16. Smoking and SMI
• People with SMI smoke more, more often,
start earlier and inhale more deeply and
spend a greater proportion of their income on
cigarettes

17. Effect of smoking on premature mortality
• Brown et al (2010) 25-year follow up of a
community cohort of 370 people with
schizophrenia.
– 164 (44%) had died (mean age of death 57.3 years
men v. 65.5 years women)
– 81% of excess mortality was from natural causes
– Smoking-related diseases estimated to account
for 70% of the excess natural mortality

18. Tobacco poverty & SMI
• SMI = income from benefits
• ‘Give back’ 25-38% benefits to the state
based on a 20-30/day habit
McCreadie & Kelly (2000)

19. Why do so many people with SMI
smoke?
• Biological reasons / Self medication
– Reduces negative symptoms (Glassman, 1993)
– Improves cognitive functioning (Levin, 1996).
– Reduces EP side effects of anti-psychotics (Ziedonis et al,
2003)
– Reduces tension??? Or gives relief from nicotine
withdrawal
• Culture of MH services
• Addictive Pharmacology of nicotine

20. When do people with SMI start
smoking?
• Estimated prevalence of tobacco users in first
episode in 58.9% (Myles et al, 2012) it has
been hypothesised it may be a vulnerability
factor to developing psychosis (de Leon, 1996)
• People with SMI ‘enter the service as non-
smokers and come out … as smokers because
of the culture’ (House of Commons Health
Committee 2005, question 239)

21. The smoking culture in mental health
services
• Elevated smoking rates amongst MH staff
• Staff accept smoking as routine and offer cigarettes
• Staff smoke with patients
• Means of pacifying distressed inpatients
• Lack of stimulation and relief of boredom in inpatient
units
• Access to cigs is a source of conflict and control
between staff and patients and between patients
• The ‘cigarette economy of institutions’
• Trade cigarettes for sexual favours
• Non-smokers initiated in smoking upon admission
Lawn 2004; Hempel et al 2000

22. Smoking bans in the NHS
• Many MH staff resisted the implementation of
smoking bans stating that patients should be allowed
to smoke because it was “a comfort” and that they
had “nothing else to live for” or “nothing else to do”
(Jochelson and Majrowski, 2006)
• Staff argued that levels of untoward incidents would
increase if smoking bans were implemented however
evidence does not support this (el-Guebaly et al,
2002)
• Once smoking is banned therapeutic activities may
increase (Jochelson and Majrowski, 2006)

23. Do people with SMI want to quit?
General
population

24. Other adverse effects of smoking
• Heavy smokers with SMI have higher rates of
rehospitalisation
• They require larger doses of anti-psychotic
medication (Ziedonis and George, 1997)
• They are more likely to have other co-morbid
substance misuse problems (Wehring et al,
2012)

25. Story so far…
• Elevated smoking levels and SMI
• Poor physical health and poor
provision/uptake of healthcare/health
promotion
• Strong chemical and cultural influences on
smoking
• But, some expressed desire to quit

26. Smoking & nicotine addiction
What works?

27. What works to help people quit?

28. Nicotine replacement therapy
• 123 trials NRT vs
placebo
• OR 1.77 (95%CI 1.66 –
1.88)
• No clear evidence of
which form/mode of
delivery best

29. Bupropion (‘Zyban’)
• Bupropion v placebo
• 31 trials
• OR 1.94 (95%CI 1.72-
2.19)

30. Varenicline (‘Champix’)
• Nicotine receptor
partial agonist
• versus placebo
• OR 3.22 (95%CI 2.43 –
4.27)
• Versus bupropion
• OR 1.66 (95% CI 1.28 -
2.16)

31. Behavioural support
• Brief advice
• Different models of psychological intervention
• Motivational enhancement
• CBT
• Support over the telephone
• Individual or group?
• Specialist training?

32. What about those with lower
motivation to quit?

33. ‘Cut down to quit’: CDTQ
‘This aims at smokers who
express unwillingness or
inability to stop smoking
in the short term by
enabling them gradually
to cut down their smoking
over an extended period
while supported by NRT
so that they may
eventually become able
and willing to attempt to
quit altogether.

34. ‘Cut down to quit’: CDTQ
• Sustained NRT for
smokers
• Some behavioural
support/motivational
enhancement
• No obligation to set a quit
date
• Build upon early success
from smoking reduction
• Look at longer-term quit
rates

35. CDTQ: 6 mo sustained abstinence

36. Cost effectiveness of smoking
cessation

37. Preventing relapse
• No effective long term psychological
intervention
• Extending the use of bupropion, varenicline or
NRT improves longer-term abstinence

38. So what works in SMI?
• Hardcore smokers
• Expressed desire to quit; motivational deficits
• Poorer provision/uptake of general/primary
healthcare and health promotion
• Poorer uptake of smoking cessation services
• Cultural influences and barriers to quitting
• Polyphamacy – powerful psychotropics

39. • Systematic review of
randomised evidence
• Non-organic psychotic
disorders
• Excluded populations
with drugs and alcohol
problems
• Any intervention
• Outcomes:
– Abstinence
– Reduction in smoking

40. Included studies
• 10 RCTs (n=10 to 298)
• 8 US studies, 1 Australian, 1 Taiwan
• Schizophrenia/schizoaffective disorder
• Usually ‘an interest in stopping or cutting
down’
• Point prevalent abstinence

41. Interventions
• Combinations of:
• NRT (6 studies)
• +/-Bupropion (3 studies)
• +/- Individual support (1 study)
• +/- group support (3 studies)
• Bupropion (5 studies)

42. Point prevalence abstinence at 3-6
months
Odds Ratio
study (95% CI)
SMI smoking prog+NRT v ALA smoking prog+NRT
George et al 2000 1.02 ( 0.29, 3.59)
Subtotal 1.02 ( 0.29, 3.59)
Individual therapy+NRT v usual care
Baker et al 2006 2.78 ( 1.23, 6.25)
Subtotal 2.78 ( 1.23, 6.25)
Bupropion+group therapy v Placebo+group therapy
Evins et al 2001 2.13 ( 0.06, 72.52)
Evins et al 2005 10.48 ( 0.52, 209.31)
George et al 2002 7.00 ( 1.19, 41.34)
Subtotal 6.34 ( 1.56, 25.74)
Bupropion+group therapy+NRT v Placebo+group therapy+NRT
Evins et al 2007 2.36 ( 0.66, 8.43)
George et al 2006 7.80 ( 0.87, 70.05)
George et al 2007 4.56 ( 1.10, 18.86)
Subtotal 3.65 ( 1.53, 8.71)
.01 .1 .2 .5 1 5 10 20 50
Odds Ratio
Favours control Favours interevention

43. Key findings
• Most studies demonstrate that those with SMI are
able to quit or reduce smoking.
• Pharmaceutical and behavioural treatments used to
treat nicotine dependence in the general population
seem to be effective in the SMI population.
• If participants were psychiatrically stable at initiation
of quit attempts, smoking cessation interventions did
not worsen their mental state.

44. Complications!
• Varenicline has been linked to suicidal behaviour
(Gunnel et al, 2009)
• Stopping smoking can reduce metabolism of some
medication resulting in higher, sometimes toxic
blood levels
 Clozapine and Olanzapine – baseline bloods
should be taken and dosage reduced by 25% in
the first week of cessation followed by weekly
blood tests until levels stabalise

45. Varenicline more recent evidence
• A recent systematic review by Cerimele and Durango
(2012) examined data from 17 studies concluded
that Verenicline treatment was not associated with
worsening of psychiatric symptoms in patients with
SMI
• No patients experienced suicidal ideation or suicidal
behaviours
• Although sample sizes were small i.e. total = 260
patients

46. Bespoke Smoking
Cessation (BSC) trial for
SMI (NIHR HTA funded)
• Prof Simon Gilbody (PI)
• Prof Helen Lester
• Dr Tim Bradshaw
• Prof Susan Michie
• Prof Robert West
• Dr Mei-See Man

47. This project was funded by the National Institute for Health Research Health
Technology Assessment (NIHR HTA) Programme (project number 07/41/05) and will
be published in full in Health Technology Assessment.
The views and opinions expressed therein are those of the authors and do not
necessarily reflect those of the HTA programme, NIHR, NHS or the Department of
Health.

48. MRC complex interventions
framework (2008)

49. Uncertainties:
• Content of the intervention
• Acceptability of the intervention
• Barriers to recruitment (staff and patients)
• Setting and mode of delivery
• Feasibility of longer-term follow-up

50. 100 service users with a
diagnosis of SMI
Randomised individually.
Bespoke smoking cessation Usual care only
Intervention plus usual care
Primary outcome expired Primary outcome expired
breath Carbon Monoxide (CO) breath Carbon Monoxide (CO)
0 6 12 0 6 12
wks mths mths wks mths mths

51. Inclusion criteria
• Documented diagnosis of Schizophrenia, schizoaffective
disorder, psychosis or Bipolar disorder
• Currently a smoker but willing to do something about
smoking
• Over 18 years age
Exclusion criteria
• Pregnant or breastfeeding
• Current co-morbid drug or alcohol abuse
• Currently being prescribed smoking cessation treatments
(NRT, Zyban, Champix)

52. Scimitar intervention
• Smoking cessation therapists trained to NHS
Level 2 Intermediate Advisor standard
• However flexible delivery to include
– More than the usual six sessions as per need
– Offer Cut Down to Quit (CDtQ) as an alternative to
abrupt cessation
– NRT – as much and for as long as patients want it
– Bupropion if requested, but not Varenicline
– Venue and times of sessions according to patient
preference

54. Outcome measures
• Primary outcome will be expired CO measurement at
12 months post-recruitment plus
– Reduction in number of cigarettes smoked (self report)
– Fagerstrom test of nicotine dependence
– Motivation to Quit questionnaire
– If successfully quit smoking, the number of cessation attempts and the
periods of cessation.
• General mental health (PHQ-95 & SF-126)
• Cost effectiveness (EuroQol EQ-5D7, Health
Economics/Service utilisation Questionnaire)
• Acceptability, fidelity and adherence with smoking cessation
programme

55. Recruitment (1)

56. Recruitment (2)
3% YORK MANCHESTER HULL
(1/38)
8%
(1/13) GP Database
29% 37%
(11/38) (17/46) Secondary Care
referral
71% 63% 92%
(27/38) (29/46) (12/13) Self Referral
Total = 97 participants

57. Qualitative study
• Semi-structured interviews with:
14 patients with SMI from across the 3
sites who received the intervention
3 MH-SCPs (one from each site)
• Thematic analysis (blind to study outcome)

58. Routine Primary Care is unsuitable
• “Doctors are always recommending me to give up smoking.
Yes. I can’t really remember what they said. They just say,
‘Do you smoke?’ And I say yeah, and they said, ‘Give up.’”
M1037
• “I’ve actually had a doctor turn round and say, after quite an
episode which was quite a lengthy episode, and I talked about
giving up, he said, oh no, you don’t want to be giving up at
the moment. So it was kind of like a medical permission to
carry on smoking… The doctor might say, as he said, terrible
thing smoking. But never actually say, you should give up,
and I’ll refer you. I’ve had to ask for that. The last thing you
want to think about is giving up, that sort of comment comes
across”. Y1085

59. Need a separate MHSCP in primary care
• “[The practice nurse] just simply said, “We’re not
putting you on the Champix”, and the other one as
well, “Not putting you on them”. And that was it. I
was out the door, gone.” M1100
• “The nurses, they don’t give you much time to talk
about it really. They just sort of pack you off with
some boxes of patches. [The MHSCP] listens to your
mental health problems as well, what you’re thinking…
she helped me to... feel at ease about not being so
hard on myself again if I’m suffering from illness…she
gave me a lot of peace of mind “ M1037

60. Need a separate MHSCP in primary care
• “A lot of the people with serious mental illness are
now seen in general practice and nowhere else..so
people are handed back to general practice, to benefit
most people, there’d have to be something done in
primary care”.MHSCP3
• “You could put this work into main stream, you know,
into CPN’s work, but I don’t know that everybody
would do it, that’s the thing, and how much time and
attention they would give, because you need to be
quite focused” MHSCP 3

61. Need for Mental Health background (1)
• It wasn’t just a stop smoking clinic for Tom, Dick and
Harry, she understood the mental health side, which is
obviously a big concern… Because I wouldn’t go to a
normal…because I’m frightened…Well [the MHSCP]
knows what I’ve got. Whereas if you go to a normal stop
smoking thing and they know you’ve got mental health
problems then it’s stigma isn’t it?... you’ve got to trust
the person who you’re talking to and be comfortable
with them, especially on mental health issues, because if
you’re talking to somebody who doesn’t understand
then you think well, you’re not on the same wavelength
as me, you don’t understand me Y1098

62. Need for Mental Health background (2)
• I found that the relationship I had with [the MHSCP],
was such that she was supportive without pushing.
And it’s very much the case that she was there to
help, for advice, rather than to ram anything down
my throat…It becomes more of a therapeutic
relationship, rather than the nurses making me, or
the nurses leading me, whereas in a therapeutic
relationship, it’s the nurses walking along beside me,
making the journey with me rather than pushing me
Y1053

63. What does ‘bespoke’ mean?
• “You work flexibly, they get someone that’s got some
understanding of their mental health issues, someone
who can work with, you know, have the time to work
with the other network of people that are involved
with them as well” MHSCP 3
• “It was individual to the person really, flexible to their
needs, like seeing them when they wanted within
reason and then not putting too much pressure on
them that’s how I saw it…just tailored to the person
see what works for each person” MHSCP2

64. Barriers to implementation (1)
• ‘Chaotic’ population
“She disengaged and was texting me saying, ‘Oh
I’ve not done too well this week so can you come
next week?’ And I’d go and she wouldn’t be
there. .. even if I could say only one of my clients
attended every appointment [but] none of them
did…I think it’s reflective of the patient group
really…. they’re just so chaotic, very few of them
had diaries and if they did it wasn’t really like a
diary it was a notebook that was all upside
down... they’d just write on one page that you
were coming and then they just put it in a
drawer” MHSCP 2

65. Barriers to implementation (2)
• Difficulty liaising with GPs:
“If the GP wouldn’t prescribe... then you’re chasing it up and then
when the client goes it’s not there and they get annoyed that
they’ve wasted a visit to the doctors. Some GP surgeries refused to
do it on my recommendation and had to see the client. So then the
client had to make an appointment with the GP which just didn’t
happen. So then I’d say well I’ll give you a letter to take with the
doc... and then they lose the letter.” MHSCP2
• Patients struggle with motivation – getting the ‘window of
opportunity’:
“I know at the moment it’s not the right time…it’s hitting the right
time with the right stuff” Y1098

66. Thank you for listening
t.bradshaw@manchester.ac.uk