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for individuals prescribed clozapine there are important considerations which need to be explored before cessation commences (Cormac et al., 2009). Individuals have reported increases in positive illness related symptoms as well as a decline in cognitive ability and function, following smoking cessation (Cole et al., 2010). The same enzyme which is used to metabolise clozapine, CYP 1A2 (Urichuk et al., 2008), is also induced in smokers by the polycyclic aromatic hydrocarbons found in tobacco smoke (Kroon, 2009), which in turn effects the metabolism of clozapine (Schaffer et al., 2009), causing a reduction in plasma concentrations (Sepalla et al., 1999; Bondolfi et al., 2005). Consequently, smokers will require a higher maintenance dose to generate the same therapeutic response in comparison to non-smokers (Meyer, 2001; van der Weide et al., 2003; Bondolfi et al., 2005; Taylor et al., 2005). Whilst very heavy smoking has also been linked to a total inability to achieve therapeutic levels with clozapine (Bender & Eap, 1998). In Contrast, plasma concentration will increase if an individual commences smoking cessation;
Three centered study and is the first RCT of smoking cessation for SMI conducted in the UK
Measured by patient treatment records kept by MH-SCPs, qualitative interviews with intervention and control participants and MH-SCPs
Smoking cessation and mental ill health
Smoking cessation and mental ill health: what does trial based evidence tell us? Dr Tim Bradshaw Senior Lecturer University of Manchester
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
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)
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)
What proportion of people with SMI smoke? General population
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
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
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
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)
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
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)
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
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)
Do people with SMI want to quit? General population
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)
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
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
Bupropion (‘Zyban’) • Bupropion v placebo • 31 trials • OR 1.94 (95%CI 1.72- 2.19)
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)
Behavioural support• Brief advice• Different models of psychological intervention• Motivational enhancement• CBT• Support over the telephone• Individual or group?• Specialist training?
What about those with lower motivation to quit?
‘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.
‘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
Preventing relapse• No effective long term psychological intervention• Extending the use of bupropion, varenicline or NRT improves longer-term abstinence
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
• Systematic review of randomised evidence• Non-organic psychotic disorders• Excluded populations with drugs and alcohol problems• Any intervention• Outcomes: – Abstinence – Reduction in smoking
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
Interventions• Combinations of:• NRT (6 studies)• +/-Bupropion (3 studies)• +/- Individual support (1 study)• +/- group support (3 studies)• Bupropion (5 studies)
Point prevalence abstinence at 3-6 months Odds Ratiostudy (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
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.
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
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
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
This project was funded by the National Institute for Health Research HealthTechnology Assessment (NIHR HTA) Programme (project number 07/41/05) and willbe published in full in Health Technology Assessment.The views and opinions expressed therein are those of the authors and do notnecessarily reflect those of the HTA programme, NIHR, NHS or the Department ofHealth.
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
100 service users with a diagnosis of SMI Randomised individually. Bespoke smoking cessation Usual care only Intervention plus usual carePrimary outcome expired Primary outcome expiredbreath Carbon Monoxide (CO) breath Carbon Monoxide (CO) 0 6 12 0 6 12 wks mths mths wks mths mths
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 ageExclusion criteria• Pregnant or breastfeeding• Current co-morbid drug or alcohol abuse• Currently being prescribed smoking cessation treatments (NRT, Zyban, Champix)
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
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
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
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)
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
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
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
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
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
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
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
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
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