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Smoking and mental health - NCSCT

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<strong>Smoking</strong> <strong>and</strong> <strong>mental</strong> <strong>health</strong><br />

smokers with schizophrenia, indicate that varenicline is effective but recommend<br />

careful supervision <strong>and</strong> monitoring for exacerbation of psychiatric symptoms. 27<br />

In terms of effectiveness this evidence is promising: the 12-week, r<strong>and</strong>omised,<br />

double-blind, multicenter US trial, in which 84 patients received varenicline <strong>and</strong><br />

43 placebo, found abstinence rates of 19% versus 4.7% at 12 weeks, <strong>and</strong> 11.9%<br />

versus 2.3% at 24 weeks. 41 Other available evidence, although limited, provides<br />

further support: a 12-week, open-label, smoking cessation trial of varenicline<br />

combined with weekly group cognitive–behavioural therapy in 112 stable<br />

outpatients with schizophrenia 42 found 2-week <strong>and</strong> 4-week continuous<br />

abstinence rates of 47.3% <strong>and</strong> of 34% respectively, <strong>and</strong> significant reductions in<br />

smoking (measured by exhaled carbon monoxide) in those who did not succeed<br />

in quitting. A pilot study in eight outpatients with schizophrenia or<br />

schizoaffective disorder, 43 r<strong>and</strong>omised to varenicline (1 mg twice a day) or<br />

placebo for 12 weeks delivered together with individual behavioural support,<br />

found that three of four participants treated with varenicline achieved<br />

continuous abstinence (weeks 8–12, verified with expired CO), compared with<br />

no participant in the placebo group. Smith et al, 44 in a study of 14 smokers with<br />

schizophrenia, found that treatment with varenicline led to some cognitive<br />

improvement, as well as to smoking reduction <strong>and</strong> reduced CO expired <strong>and</strong><br />

cotinine levels.<br />

In a multicentre r<strong>and</strong>omised trial of varenicline in over 500 smokers with<br />

major depression, reported at the time of writing only in a press statement, 4-<br />

week continuous abstinence rates at 3 months were 35.9% in those receiving<br />

varenicline, compared with 15.6% of participants receiving placebo, <strong>and</strong> 20.3%<br />

<strong>and</strong> 10.4% respectively at 1 year. 45 The study is reported to have found no<br />

difference in adverse events between treatment groups, although detailed<br />

comparisons are not provided. 45 Further r<strong>and</strong>omised trials <strong>and</strong> surveillance data<br />

on use of varenicline in people with <strong>mental</strong> disorders are urgently required, but<br />

the available evidence suggests that, with careful supervision <strong>and</strong> monitoring,<br />

varenicline is likely to be safe <strong>and</strong> effective in this group.<br />

5.2.5 Cautions on use of bupropion <strong>and</strong> varenicline<br />

In view of concerns over the occurrence of depression, suicidal thoughts, suicide<br />

attempts <strong>and</strong> completed suicides in patients taking varenicline, <strong>and</strong> updates from<br />

the Medicines <strong>and</strong> Healthcare products Regulatory Agency 46 <strong>and</strong> the US Food<br />

<strong>and</strong> Drug Administration (FDA), 47 current guidance from The Royal College of<br />

General Practitioners (RCGP) <strong>and</strong> The Royal College of Psychiatrists 31 in the UK<br />

recommends that both varenicline <strong>and</strong> bupropion be used under close,<br />

coordinated supervision by <strong>health</strong> professionals, especially in the first 2–3 weeks<br />

of therapy, that family members <strong>and</strong> caregivers be alerted to the potential for<br />

adverse effects, <strong>and</strong> that varenicline or bupropion be discontinued immediately<br />

in the event of any cause for concern.<br />

88 © Royal College of Physicians 2013

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