Closing the treatment gap in alcohol dependence thessalonika 2015

49
Closing the treatment gap in alcohol dependence : the role of nalmefene Dr Antoni Gual [email protected] 5 o ΜΕ ∆ΙΕΘΝΗ ΣΥΜΜΕΤΟΧΗ ΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΥΓΕΙΑ ΣΥΝΕΔΡΙΟ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΙΑΤΡΙΚΗ ΠΕΡΙΘΑΛΨΗ

Transcript of Closing the treatment gap in alcohol dependence thessalonika 2015

Page 1: Closing the treatment gap in alcohol dependence thessalonika 2015

Closing the treatment gap in alcohol dependence : the role of nalmefene

Dr Antoni Gual [email protected]

Υπό την αιγίδαΓ΄ Ψυχιατρικής Κλινικής ΑΠΘ

Τµήµατος Ιατρικής ΑΠΘ

19–21Μαρτίου 2015

ΘεσσαλονίκηTHE MET HOTEL

5o

ΜΕ ∆ΙΕΘΝΗ ΣΥΜΜΕΤΟΧΗ

ΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΥΓΕΙΑ

ΣΥΝΕΔΡΙΟ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΙΑΤΡΙΚΗ ΠΕΡΙΘΑΛΨΗ

Προκαταρκτικό πρόγραμμα

Page 2: Closing the treatment gap in alcohol dependence thessalonika 2015

Conflicts of interest

Interest Name of organisa/on

Current roles and affilia/ons

Addic;ons Unit, Psychiatry Dept, Neurosciences Ins;tute, Hospital Clinic, University of Barcelona; IDIBAPS; RTA; Vice President of INEBRIA, President of EUFAS

Grants Lundbeck, D&A Pharma, FP7, SANCO

Honoraria Lundbeck, D&A Pharma, Servier, Lilly, Abbvie

Advisory board/consultant

Lundbeck, D&A Pharma, Socidrogalcohol (Alcohol Clinical Guidelines) 2013

Page 3: Closing the treatment gap in alcohol dependence thessalonika 2015

Index

•  Burden of disease •  The first gap: role of Brief Interven;ons •  The second gap: need for a reduc;on approach

•  The second gap: the role of nalmefene •  Framing Nalmefene within a psychosocial support strategy

•  Summary

Page 4: Closing the treatment gap in alcohol dependence thessalonika 2015

Index

•  Burden of disease •  The first gap: role of Brief Interven;ons •  The second gap: need for a reduc;on approach

•  The second gap: the role of nalmefene •  Framing Nalmefene within a psychosocial support strategy

•  Summary

Page 5: Closing the treatment gap in alcohol dependence thessalonika 2015

Prevalence of Alcohol Dependence (AD) and access to treatment. Data from the APC study

AD diagnosis by GP

Pa;ents visited by the GP 13,003

Pa;ents iden;fied as alcohol dependent 5.1% (663)

Pa/ents who received professional help 21.8% (n=145)

•  Six EU countries •  GPs interviewed about

pa;ents seen in a given day •  Pa;ents interviewed with

standardized ques;onnaires when they exit consulta;on

Rehm J, et al. Ann Fam Med. 2015.

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12.20 12.20

7,50

5.90

8,88

Trea

tmen

t gap

* (%

)

Kohn et al. Bull World Health Organ 2004;82:858–866

Treatment gap in alcohol dependence

6

*Treatment gap=difference between number of people needing treatment for mental illness and number of people receiving treatment

Alcohol abuse and dependence have the widest treatment gap among all mental disorders – less than 10% of patients with alcohol abuse and dependence are treated

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The double gap

Pa;ents with AUD in PHC sebngs

Risky drinkers offered brief

advice to reduce

Alcohol dependent offered treatment

1st GAP

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Symptoms of depression and alcohol dependence frequently overlap1,2

8

1. Boden JM, et al. Addiction 2011;106:906-914. 2. Watts M. B J Nursing. 2008;17(11):696-699 . 3. Shivani R, et al. Alcohol Research & Health. 2002;26:90-98

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Symptom overlap between alcohol dependence and anxiety disorders1

1. Brady, et al. Am J Psychiatry . 2007;164(2):217-221. 2.. DSM-IV. American Psychiatric Association. 1994. 3. Shivani, et al. Alcohol Research Health 2002;26(2),90-98. 4. The ICD-10 Classification of Mental and behavioral disorders - Clinical Description and diagnostic guidelines. WHO 1992

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20%-30% of psychiatric patients are also alcohol dependent1

Lifetime prevalence of psychiatric disorders and co-occurrent alcohol dependence1,2

31%

Comorbid alcohol

dependence

21%

21%

Comorbid alcohol

dependence

26%

Anxiety disorder Mood disorder

Lifetime prevalence of psychiatric disorder2

Lifetime prevalence of co-occurrent alcohol dependence and psychiatric disorder1

12%

24%

7%

28%

6%

30% 17%

26%

4%

28%

GAD Phobia PTSD

Major

depressive disorder Bipolar

disorder

1. Kessler et al. American Journal of Orthopsychiatry 1996; 66(1): 17-31 2. National Comorbidity Survey Replication NCS-R. Lifetime prevalences estimates

www.hcp.med.harvard.edu/ncs/index.php

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Screening or early iden;fica;on?

•  Screening: Strategy used in a popula;on to iden;fy an unrecognised disease in individuals without signs or symptoms.

•  Targeted screening: Screening limited to selected popula;on (because of high risk or high vulnerability)

•  Early iden/fica/on: Evalua;on of pa;ents in whom signs of alcohol playing a nega;ve role in a case history are present

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The AUDIT-­‐C

1. How ofen do you have a drink containing alcohol?

2. How many standard drinks containing alcohol do you have on a typical day when drinking?

3. How ofen do you have six or more drinks on one occasion 0) Never 1) Less than monthly 2) Monthly 3) Weekly 4) Daily or almost daily

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The AUDIT-­‐C

1. How ofen do you have a drink containing alcohol?

2. How many standard drinks containing alcohol do you have on a typical day when drinking?

3. How ofen do you have six or more drinks on one occasion 0) Never 1) Less than monthly 2) Monthly 3) Weekly 4) Daily or almost daily

Cut off point for Hazardous drinking:

•  4 or more in women •  5 or more in men

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•  No standard defini/on – can range from a short conversa/on to a number of structured sessions1-­‐5

•  Brief Interven;ons are carried out in general community sebngs (primarily used in primary care clinics) and are delivered by HCPs (Health Care Professionals)

•  Includes the giving of informa;on and advice

•  Encouragement to the pa;ents to consider the posi;ves and nega;ves of their drinking behaviour

•  Offers support to pa;ents if they do decide that they want to cut down

•  Is ;mely and opportunis;c

Brief interven;on: Overview

1. Raistrick et al. Na;onal Treatment Agency for Substance Misuse, 2006, p79; 2. Scobsh Intercollegiate Guidelines Network, 2003; 3. NICE public health guidance 24: Alcohol-­‐use disorders: preven;ng harmful drinking. June 2010; 4. NICE guidance CG115: Alcohol dependence and harmful alcohol use (CG115). February 2011; 5.

WHO. Am J Public Health 1996;86:948-­‐55

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Brief Interven;on: Level 1

Raistrick et al. Review of the effec;veness of treatment for alcohol problems, 2006

1.  Some assessment of alcohol use

2.  Feddback on the screening assessment (clinical findings plus compare to the general popula;on?

3.  Some clear advise on how to cut down (or stop drinking)

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Index

•  Burden of disease •  The first gap: role of Brief Interven;ons •  The second gap: need for a reduc/on approach

•  The second gap: the role of nalmefene •  Framing Nalmefene within a psychosocial support strategy

•  Summary

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The double gap

Pa;ents with AUD in PHC sebngs

Risky drinkers offered brief

advice to reduce

Alcohol dependent offered abs;nence oriented treatment

1st GAP 2nd GAP

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Nalmefene blocks the µ-opioid receptor3

Nalmefene modulates the κ-opioid receptor3

2.9% 3.0% 3.1% 4.2%

5.7% 5.9% 5.9% 6.5%

8.1% 8.4% 8.6% 8.9%

10.6% 30.3%

49.5%

0 10 20 30 40 50 60

Treatment would not help Other barriers

No openings in a programme Did not want others to find out

Did not have time No programme having type of treatment

Did not feel need for treatment No transportation/inconvenient

Thought could handle without treatment Health coverage did not cover cost

Social stigma Did not know where to go for treatment

Might have negative effect on job No health coverage & could not afford cost

Not ready to stop using

Percentage of patients

Reasons given for not receiving alcohol treatment in the past year by persons who needed treatment and who perceived a need for it: 2009 to 2012 Survey of approx. 67500 interviewed persons in the US SAMHSA. Results from the 2012 Na;onal Survey on Drug Use and Health, 2013

Why does the gap exist?

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Pa;ents’ treatment goal preference

UKATT: 742 patients seeking help for alcohol problems1

Canada: 106 patients with chronic alcoholism2

1. Heather et al. Alcohol Alcohol 2010;45(2):128–135; 2. Hodgins et al. Addict Behav 1997;22(2):247–255

54% 46%

0

20

40

60

80

100

Abstinence Alcohol reduction

Per

cent

age

of p

atie

nts

(%)

Treatment preference

46% 44%

9%

0

20

40

60

80

100

Abstinence Moderate drinking

Unsure P

erce

ntag

e of

pat

ient

s (%

)

Treatment preference

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Benefits of reduc;on: reducing consump;on by a constant amount translates to a higher reduc;on in mortality if the reduc;on is at higher

levels

•  Reduc;on of 36 g/day (3 drinks) from a baseline of 60 g/day corresponds to reduced mortality risk of 38 per 10,000

•  Reduc;on of 36 g/day from a baseline of 96 g/day corresponds to reduced mortality risk of 119 per 10,000

It’s the heavy drinking day that leads to harm!!

Men Women

Ris

k of

dea

th (%

)

0 20 40 60 80 100 Alcohol consump;on (g/day)

18

12

4

0

16

8 10

2

14

6

Rehm et al. Addiction 2011;106(Suppl 1):11–19; Rehm & Roerke. Alcohol Alcohol 2013;48:509–513

Lifetime risk of death due to alcohol-related injury

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‘…For all people who misuse alcohol, offer interven7ons to promote abs7nence or moderate drinking as appropriate’ ‘...For harmful drinking or mild dependence, without significant comorbidity, and if there is adequate social support, consider a moderate level of drinking as the goal of treatment’

NICE. Clinical guideline 115, 2011

‘…it’s best to determine individual goals with each patient. Some patients may not be willing to endorse abstinence as a goal, especially at first. If a patient with alcohol dependence agrees to reduce drinking substantially, it’s best to engage him or her in that goal while continuing to note that abstinence remains the optimal outcome.’

NIAAA. Helping Pa;ents Who Drink Too Much, 2007

“In case an alcohol-dependent patient is not able or willing to become abstinent immediately, a clinically significantly reduced alcohol intake with subsequent harm reduction is also a valid, although only intermediate, treatment goal, since it is recognised that there is a clear medical need in these patients as well.”

EMA. Guideline on the development of medicinal products, 2010

Reduc;on is included in several interna;onal guidelines, either as an intermediate goal, or for those pa;ent that cannot accept or achieve abs;nence, as an acceptable treatment goal in itself

16 countries in EU have guidelines for treatment of alcohol dependence, and 10 out of these countries have guidelines that recommend both abs;nence and reduc;on.

14 countries in EU, do not have any guidelines for treatment of alcohol dependence, but a clinical prac;ce, and 12 out of these countries recommend both abs;nence and reduc;on in

their clinical prac;ce.

Reduc;on accepted as a treatment op;on by 26/30 European countries

Reduc;on of alcohol consump;on is endorsed by interna;onal guidelines

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The double gap

Pa;ents with AUD in PHC sebngs

Risky drinkers offered brief

advice to reduce

Alcohol dependent offered abs;nence oriented treatment

2nd GAP

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Pa;ents with AUD in PHC sebngs

Risky drinkers offered brief

advice to reduce

Alcohol dependent offered abs;nence oriented treatment

Which are the clinical characteris;cs of those pa;ents?

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Which are the clinical characteris;cs of those pa;ents?

a.  Demographic characteris;cs b.  Clinical status c.  Level of mo;va;on d.  Pa;ent goals

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Alcohol dependence is typically a progressive disease1,2

References >

EARLY-STAGE

Ability to function: Most likely functional (e.g. employed, in a relationship)

Ability to function: Likely non-functional

DEPENDENCE MID-STAGE

DEPENDENCE LATE-STAGE

Health consequences: Minimal/not life-threatening Anxiety, depressive symptoms Elevated liver enzymes Hypertension

Health consequences: Severe/possibly life-threatening Liver cirrhosis Stroke

Social consequences: Family conflict, neglect Inability to concentrate on job, absenteeism

Social consequences: Divorce, spouse/child abuse Job loss, chronic unemployment, deviant behaviour

DEPENDENCE

1.  Burge et al. Am Fam Physician. 1999 59(2): 361-370 2.  Edwards & Gross. BMJ 1976; 1: 1058-1061

Ability to function: Marginally functional (e.g. employed in non-demanding job, problems in marriage or relationship)

Health consequences: More severe health consequences, already carrying alcohol-related medical history eg. depression, obesity, visits to hospital, withdrawal symptoms (tremor,anxiety), sleep disorders, clinical signs of liver deficiency (oedema, portal hypertension, coagulation disorder), injuries (driving, other accidents) ischemic encephalopathy, heart hypertophy

Social consequences: Significant loss of social interaction, irritability, difficulty to follow team rules, occasionally violent (eg. when provoked, have gone to football match or lost patience by kid’s behaviour). Financial problems, legal problems (eg. due to debts, car accident, caught drunk when driving, violence)

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Some prac;cal examples.

•  Jesús M. 49 años, broker •  Maria R. 35 años, housewife •  Juana F. 26 años, student

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Some prac;cal examples.

Jesús M. 49 years. •  Married, 2 sons, works as a broker at an insurance

company •  Moderate hypertension. Smoker 1 pack/day •  Drinks with clients (6 beers) and also after dinner at

home (3 whiskies). •  Comes under his wifes’ pressure. He is worried with

hypertension since his father died from a CVD. •  Has tried unsuccessfully to reduce his drinking. He

does not want to stop drinking with clients but thinks he should stop drinking at nights.

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Some prac;cal examples.

Maria R. 35 years •  Married, a daughter 7 years old. Housewife. •  No somathic diseases. Depression treated with

sertraline since 2 years. •  Drinks alone, above 1 liter of wine daily. Refers

moderate depression and anxiety symptoms. •  Ready to stop drinking initially, but wants to drink

moderately at family events (because of social pressure) at a later stage.

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Some prac;cal examples.

Juana F. 26 years.

•  Last year in a Business school. Lives with her parents.

•  Gets drunk on weekends. Abstainer the rest of the week.

•  Decreased academic performance, low mood and difficulties with parents.

•  Worried because of her sexual behaviour when drunk.

•  Wants to avoid drunkeness on weekends, but thinks a bit of drinking is essential when meeting with friends in order to overcome her social phobia.

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•  Mild to moderate AUD •  Socially stable •  Psychological distress (anxiety/

depression that may or may not be linked to alcohol intake)

•  Desire to reduce their drinking to avoid problems

•  Desire not to stop drinking completely

What do those cases have in common?

Page 31: Closing the treatment gap in alcohol dependence thessalonika 2015

Index

•  Burden of disease •  The first gap: role of Brief Interven;ons •  The second gap: need for a reduc;on approach

•  The second gap: the role of nalmefene •  Framing Nalmefene within a psychosocial support strategy

•  Summary

Page 32: Closing the treatment gap in alcohol dependence thessalonika 2015

Alcohol use Abs;nence -­‐ low risk -­‐ hazardous use -­‐ harmful use -­‐-­‐ dependence

Alcohol related problems

Recommended

psychosocia

l interven;o

ns

Primary preven;

on -­‐-­‐ Brie

f interven;o

ns -­‐-­‐ Special

ized treatment

Pharmacological interven/ons

Page 33: Closing the treatment gap in alcohol dependence thessalonika 2015

Alcohol use Abs;nence -­‐ low risk -­‐ hazardous use -­‐ harmful use -­‐-­‐ dependence

Alcohol related problems

Recommended

psychosocia

l interven;o

ns

Primary preven;

on -­‐-­‐ Brie

f interven;o

ns -­‐-­‐ Special

ized treatment

Pharmacological interven/ons

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Widening the scope of pharmacological treatments

•  Classical approach: Abs;nence oriented (disulfiram*, acamprosate*, naltrexone*, topiramate)

•  Subs;tu;on therapy: BZD, sodium oxibate, baclofen

•  Reduc;on approach: nalmefene*, naltrexone, topiramate, gabapen;ne.

* Registered indica;on

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Nalmefene – What it does!

•  Nalmefene diminishes the reinforcing effects of alcohol, helping the patient to reduce drinking possibly by modulating cortico-mesolimbic functions.

Nalmefene Summary of Product Characteristics; Nalmefene European Public Assessment Report, 2012; Clapp et al. Alcohol Res Health 2008;31(4):310–339

Prefrontal cortex

Nucleus accumbens

Amygdala Ventral tegmental area

Hippocampus

Nalmefene

Areas in the brain affected by alcohol, including the mesolimbic dopamine system

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Nalmefene indication

Nalmefene Summary of Product Characteristics, 2012

•  Nalmefene is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification

•  Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption

•  Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after initial assessment

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Mann et al. Biol Psychiatry 2013;73(8):706–713; Gual et al. Eur Neuropsychopharmacol 2013;

van den Brink et al. Poster at Research Society on Alcoholism 2012; Data on file

Living with someone: 65–86%

(65–85%) Higher

education: 24–40%

(23–32%)

Employed: 54–63%

(61–64%)

Gender: 62–78%

(67–77%) men

Age: 44–53 yrs (44–52 yrs)

Family history: 36–62%

(49–61%)

Years since onset:

11–15 yrs (11–14 yrs)

Not previously treated: 59–78%

(60–70%)

Number of patients: 854 (1,997)

High and very high drinking-risk levels at baseline and randomisation – demographics*

Numbers in ()=total sample *No significant differences between placebo and nalmefene arms; Data show range of the means from individual studies

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HDD: change from baseline in the 6-month studies – patients with at least high DRL at baseline and randomisation

23 HDDs

11 HDDs

23 HDDs

10 HDDs

Difference: -­‐3.7 HDDs, p=0.0010

Difference: -­‐2.7 HDDs, p=0.0253

ESENSE 2 ESENSE 1

van den Brink et al. Alcohol Alcohol 2013;48(5):570–578; Data on file

MMRM (OC) FAS es;mates and SE; *p<0.05, **p<0.01, ***p≤0.001; MMRM=mixed-­‐effect model repeated measure; OC=observed cases; FAS=full analysis set; SE=standard error

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TAC: change from baseline in the 6-month studies – patients with at least high DRL at baseline and randomisation

113 g/day

43 g/day

102 g/day

44 g/day

Difference: -­‐18.3 g/day, p<0.0001

Difference: -­‐10.3 g/day, p=0.0404

ESENSE 2 ESENSE 1

MMRM (OC) FAS es;mates and SE; *p<0.05, **p<0.01, ***p<0.001; MMRM=mixed-­‐effect model repeated measure; OC=observed cases; FAS=full analysis set; SE=standard error van den Brink et al. Alcohol Alcohol 2013;48(5):570–578; Data on file

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Onset of action

37th RSA & 17th ISBRA

JUNE 21-­‐25, 2014; BELLEVUE, WASHINGTON

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Index

•  Burden of disease •  The first gap: role of Brief Interven;ons •  The second gap: need for a reduc;on approach

•  The second gap: the role of nalmefene •  Framing Nalmefene within a psychosocial support strategy

•  Summary

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Basic psychosocial strategies

•  Monitor alcohol consump;on – TLFB – Apps

•  Mo;va;onal approach

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Timeline followback

•  Retrospec;ve assessment of drinking behaviour.

•  Reliable and valid for a variety of popula;ons for ;me frames of up to one year.

(Sobell & Sobell, 1992, 1996)

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Avoid a confrontational approach

•  Review of four decades of treatment outcome research. •  A large body of trials found no therapeutic effect of

confrontational strategies relative to control or comparison treatment conditions.

•  Several have reported harmful effects including increased drop-out, elevated and more rapid relapse.

•  This pattern is consistent across a variety of confrontational techniques tested.

•  In sum, there is not and never has been a scientific evidence base for the use of confrontational therapies.

WR. Miller, W. White; 2007

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Mo;va;onal Interviewing

•  New golden standard for the psychological approach to addic;ve behaviours

•  Radical change: – external confronta;on as a technique vs internal confronta;on as a goal

– Pa;ent centered – Spirit: partnership, compassion, evoca;on and acceptance

WR. Miller, S. Rollnick; 2012

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B

R

E N

D

A

BRENDA

Biopsychosocial evaluation

Report to the patient on assessment

Empathetic understanding of the patient’s problem

Needs expressed by the patient that should be addressed

Direct advice on how to meet those needs

Assessing response/ behaviour of the patient to advice and adjusting treatment recommendations

Clinical management – BRENDA

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Brief Interven/on: Level 2

Raistrick et al. Review of the effec;veness of treatment for alcohol problems, 2006

Structured, motivation enhancing intervention, as opposed to just screening and brief advice:

1.  Careful History

2.  Clinical Examination

3.  Laboratory testing

4.  Detailed and repeated review of drink diaries

5.  Motivational approach

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•  AUD are a brain disease and a public health problem •  AUD are underdiagnosed (First Gap) •  Patients who do not respond to BI should be offered more

intensive treatments, including a reduction approach (Second Gap)

•  Reduction of alcohol consumption is a feasible goal with nalmefene – efficacy is evident immediately and maintained up to 1 year The ‘as-needed’ dosing, and the reduction goal are well accepted and empower the patient

•  Nalmefene must be prescribed within a psychosocial support strategy that is based on motivational principles and monitors alcohol consumption carefully

Summary and conclusions

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Closing the treatment gap in alcohol dependence : the role of nalmefene

Dr Antoni Gual [email protected]

Υπό την αιγίδαΓ΄ Ψυχιατρικής Κλινικής ΑΠΘ

Τµήµατος Ιατρικής ΑΠΘ

19–21Μαρτίου 2015

ΘεσσαλονίκηTHE MET HOTEL

5o

ΜΕ ∆ΙΕΘΝΗ ΣΥΜΜΕΤΟΧΗ

ΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΥΓΕΙΑ

ΣΥΝΕΔΡΙΟ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΙΑΤΡΙΚΗ ΠΕΡΙΘΑΛΨΗ

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Thanks for your attention !!! Moltes gracies !!!

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