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Gay Sutherland (Clinical Psychologist) Visiting Researcher - Tobacco Research Unit Inst. of Psychiatry, Psychology & Neuroscience King’s College London Smoking Cessation

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Gay Sutherland (Clinical Psychologist)Visiting Researcher - Tobacco Research Unit

Inst. of Psychiatry, Psychology & NeuroscienceKing’s College London

Smoking Cessation

2

Smoking Still Kills! (Figs for England)

Obesity:

34,100

Smoking:

79,100

Alcohol:

6,669

Suicide:

5,377

Illegal drugs:

1,605

HIV:

504

Traffic:

1,850

Leading cause of preventable death

ASH, Smoking Statistics: Illness & Death 2014

For every death caused by smoking ~20smokers are suffering from a smoking-related disease(a)

Smoking interventions save public purse more than £2 for every £1 spent(b)

(a) U.S. Dept of Health & Human Services (2010): The Biology and Behavioral Basis for Smoking-Attributable Disease: Report of the Surgeon General. Atlanta, GA.

(a) BMA News: “What price public health? (June 2016)

Tobacco costs economy > £11 billion/yr

£2.5 billion cost to NHS

474,000 smoking-related hospital admissions

(2015-16)

Smokers see GPs 35% more often than non-

smokers

Non-Life Threatening Diseases Linked to Smoking: Age-related hearing loss

Cataracts

Chronic back and neck pain

Crohn’s disease

Dementia

Diabetes (T2)

Erectile dysfunction

Gum/peridontal disease

Macular degeneration

Osteoarthritis

Osteoporosis

Rheumatoid arthritis

Tissue damage (by cold exposure)

Skin wrinkles

Adapted from: Cigarettes: What the warning labels doesn’t tell you. American Council on Science & Health (ACSH) 1997

Smokers Attending NHS Stop Smoking Services2001 -2017

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100000

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900000

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Set a Quit Day 4 Wk Self-Reported Quit CO Validated Quit

Statistics on NHS Stop Smoking Services in England: NHS Digital

Prevalence of Cigarette Smoking

2007 - 2017

A-C1: Professional to clerical occupation C2-E: Manual occupation

23.3%

11.7%

16.9%

www.smokinginengland.info/latest-statistics

Mental Health and Smoking?

8

Mental Illness & Smoking:Scale of the Problem?

>40% prevalence !!

>40% of tobacco deaths are in those with mental illness or substance misuse

Die 15-25 yrs earlier

Embedded part of culture of mental health settings: “Their only pleasure”

De-stressor

Helps therapeutic relationship

Boredom etc

Genetics

Self-Medication - Biological e.g. Improve cognitive deficits, reduce side effects of anti-

psychotic medications

Why do so many people with mental illness smoke?

10

Barriers to Intervening

Mental health staff have higher smoking rates than general pop. and less likely to support cessation

Believe mentally ill smokers do not want to quit

Believe they can not quit

Believe quitting would negatively affect mental health and make management difficult

11All Wrong

Motivation to Quit:

Among Smokers:(Health Survey England)

• 66% of gen pop. want to quit

•69% on psychotropic drugs want to quit

• 61% of those with long-standing mental

health condition want to quit

NHS Information Centre: Health Survey for England. www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles-related-surveys/health-survey-for-england 12

Are mentally ill smokers able to quit?

13

Meta-Analytic Review:

14

Most studies found mentally ill smokers could quit or significantly reduce smoking

Same interventions that work with other smokers also work with those with mental illness (Behavioural Support + Stop-Smoking Medications)

Banham and Gilbody. Addiction 2010; 105(7): 1176-89 15

Is it safe for mentally ill smokers to quit?

16

“Treating smokers with stable psychiatric

conditions does notworsen their mental

state”

Banham and Gilbody. Addiction 2010; 105(7): 1176-89

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Mixed Anxiety & Depression

Stress

Blalock 2008Kahler 2009Steinberg 2011Mino 2000Chassin 2002Total

Manning 2005Hajek 2010Chassin 2002Total

Favours Quitters Favours Smokers

Depression

Anxiety

Solomon 2006Dawkins 2009McDermott 2011Becona 2002Total

Solomon 2006Berlin 2010Blalock 2008Dawkin 2009Kahler 2011Vazquez 1999Busch 2011Kahler 2002Munafo 2008Kinnunen 2006Total

Favours Quitters Favours Smokers

-1 -0.5 0 0.5 1

Taylor et al., BMJ 2014

Effect same as antidepressants

19

Positive Affect

Psychological Quality of Life

McFall 2006Stewart 1995

Balduyck 2011Croghan 2005

Longmoore 2007Uist-Paulsen 2006

Mitra 2004Sarna 2008

Total

Blalock 2008Croghan 2005

Mitra 2004

Total

Favours Smokers Favours Quitters

-0.5 0 0.5 1

Smoking cessation is associated with

Reduced:• Depression• Anxiety• Stress

&Improved• Mood• Quality of Life

vsContinuing to Smoke

Taylor et al., BMJ 2014

20

Anthenelli RM et al. Ann Intern Med 2013; 159: 390-400

Montgomery-Asberg Depression Rating Scale (MADRS):Mean Change from Baseline (95% CI)

21

Anthenelli RM et al. Ann Intern Med 2013; 159: 390-400

Hamilton Anxiety Rating (HAM-A):Mean Change from Baseline (95% CI)

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Treatment

Update

Medications Efficacy: Cochrane Reviews

Stead et al 2008, Cahill et al 2012• Varenicline: N=6,166• Single NRT: N=51,265• Dual NRT: 4,664• 95% CIs from meta-analyses

26

Pharmacotherapy Used (%) in Stop Smoking Services England 2016-17 (NHS Digital Data)

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34

25

0 2 3 17

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80Single NRTCombined NRTVareniclineBupropionNRT + Var or BupE-Cig + 1 or more Pharmaco.E-CigNoneUnknown

Pharmacotherapy Used in Quit Attempt

%

N=12859 adults who smoke and tried to stop, or who stopped in the past year; method is coded as any (not exclusive) use

E-cigarette use for quitting has plateaued

www.smokinginengland.info/latest-statistics (Slide Designed by Robert West)

Shahab L, McEwan A, et al. Cost-effectiveness of pharmacotherapy for smoking cessation. 2012 www.ncsct. co.uk/usr/pub/B7_Cost-

effectiveness_pharmacotherapy.pdf

What can you do in 30 seconds to promote quit

attempts?

All NHS Staff Should be Trained to Offer“Very Brief Advice” (30 secs)

Given opportunistically

Evidence-Based, Effective & Fast!

Satisfies QoF

GP Training Module: BMJ Learning Website - Search “VBA”

Or at www.ncsct.co.uk/VBA

ASKAbout smoking status:

“Are you still smoking?”

“How’s the smoking?”

www.ncsct.co.uk/VBA

ADVISEThe best way to stop:

“The very best way to stop is with support and medication”

“Both available on the NHS”

“Make it much more likely you will stop and stay stopped”

www.ncsct.co.uk/VBA

ACT:

Offer Medication & Support:

“We’ve got a fantastic specially trained nurse/HCA etc running our stop

smoking service”

“Reception will make you an appointment”

www.ncsct.co.uk/VBA

Note:

www.ncsct.co.uk/VBA

Don’t …Advise them to stop!

Don’t …Ask how much or what they smoke!

Don’t …Even ask if they want to stop!

Motivation to Quit?

What can you do with 1-3 minutes?

As above plus - Prescribe stop-smoking medication in those who want to stop on

their own. Recommend online or phone support

Use of Champix in those with Psychiatric

Illness?

Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

“Eagles” Study

Large-scale, multi-site, randomized,double-blind, triple dummy, placebo controlled trial comparing efficacy of varenicline vs bupropion vs NRT patch and placebo in smokers with and without a diagnosis of psychiatric disorderTrial requested by FDA, who consulted on trial design, funded by GSK & Pfizer

Eagles Study:

Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

161 centers in 16 countries on 6 continents

8144 smokers (4028 non-psychiatric: 4116 psychiatric)

30th Nov 2011 – 13th Jan 2015

Eagles Study Details:

2037 203520382034*NiQuitin CQ 21mg per 24 hour with taper

*

Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Primary Outcome Measure: % of subjects reporting at least one of the following neuropsychiatric adverse events during treatment and up to 30 days after last dose:

Primary Efficacy Measure: CO-confirmed 4-week continuous abstinence rates (CAR) for Weeks 9-12

AnxietyDepressionFeeling abnormalHostility

AgitationPanicAggressionParanoiaDelusionsPsychosisHallucinationsSuicidal ideationHomicidal ideationSuicidal behaviorManiaCompleted suicide

Classified asModerate

orSevere

Classified asSevere

42

Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Neuropsychiatric Adverse Events:

Results

44

Severe-Only NPS AEs in the Primary EndpointSecondary Outcome Measure

Varenicline Bupropion NRT Placebo

Non-Psychiatric Cohort, N 990 989 1006 999

NPS AE Endpoint, n (%) 13 (1.3%) 22 (2.2%) 25 (2.5%) 24 (2.4%)

Severe Only 1 (0.1%) 4 (0.4%) 3 (0.3%) 5 (0.5%)

Psychiatric Cohort, N 1026 1017 1016 1015

NPS AE Endpoint, n (%) 67 (6.5%) 68 (6.7%) 53 (5.2%) 50 (4.9%)Severe only 14 (1.4%) 14 (1.4%) 14 (1.4%) 13 (1.3%)

45

Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Severe-Only NPS AEs in the Primary EndpointSecondary Outcome Measure

Varenicline Bupropion NRT Placebo

Psychiatric Cohort, N 1026 1017 1016 1015

NPS AE Endpoint, n (%) 67 (6.5%) 68 (6.7%) 53 (5.2%) 50 (4.9%)

Severe Only 14 (1.4%) 14 (1.4%) 14 (1.4%) 13 (1.3%)

Psychiatric Cohort, N 1026 1017 1016 1015

NPS AE Endpoint, n (%) 67 (6.5%) 68 (6.7%) 53 (5.2%) 50 (4.9%)Severe only 14 (1.4%) 14 (1.4%) 14 (1.4%) 13 (1.3%)

46

Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016 Apr 22. doi: 10.1016/S0140-6736(16)30272-0 [Epub ahead of print]

Quit Rates:Results

Mood Scores:Pre - Post Treatment

Depression & Anxiety:

HADS Mean Total Score by Week and Cohort

Secondary Outcome Measure

Treatment

Varenicline 1.0 mg BIDBupropion 150 mg BIDNRT patch QDPlacebo https://clinicaltrials.gov/ct2/show/NCT01456936

Data on file 51

Depression & Anxiety:

HADS Mean Total Score by Week and Cohort

Secondary Outcome Measure

Treatment

Varenicline 1.0 mg BIDBupropion 150 mg BIDNRT patch QDPlacebo https://clinicaltrials.gov/ct2/show/NCT01456936

Data on file 52

Eagles Study Conclusions: No significant increase in rates of moderate

or severe neuropsychiatric AEs in varenicline or bupropion compared with patch or

placebo, in those with or without psychiatric disorders

Varenicline had superior efficacy to patch, bupropion, and placebo in both cohorts

Bupropion and patch more effective than placebo

E-Cigarettes or Vaporisers

54

National Centre for Smoking Cessation

TrainingFeb 2016

www.ncsct.co.uk

National Centre for Smoking Cessation Training

“Stop smoking services should be opento e-cig use in people keen to try them to help then quit”

“This is especially so in those who have tried and failed to quit using licensed stop smoking medicines”

The Clock Keeps on Ticking…

Each year delaying quitting…..?Each day delaying quitting…..?

60

Take Home Message:

Use very brief advice, to keep triggering repeatedattempts to stop

Offering treatment can spur quit attempts in smokers who might not have seemed motivated

Champix + Behavioural Support currently most effective. Single NRT the least

If you don’t mention smoking, smokers think it’s not important, OR that you don’t think they can quit!