Clinical strategies in the management of Alcohol Use Disorders. Lundbeck Institute, Copenhague march 2015

Clinical strategies in the
management of alcohol use
disorders
Antoni Gual
Addictions Unit.
Psychiatry Dept. Neurosciences Institute.
Hospital Clínic de Barcelona. IDIBAPS.
tgual@clinic.cat

Conflicts of interest
Interest Name of organisation
Current roles and
affiliations
Addictions Unit, Psychiatry Dept,
Neurosciences Institute, 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

Index
•  Who is in front of us? A humanistic approach
to persons with AUD.
•  Is patient centered care needed?
•  The role of assessment
•  Setting goals through shared decision making
•  Pharmacological treatments
•  Psychosocial treatments
•  Summary & Conclusions

Your opinion matters !!
•  What is the biggest challenge when
managing alcohol dependent patients at the
clinic?
Please, write down in a piece of paper a
short answer to this question
4

Index
•  Who is in front of us? A humanistic
approach to persons with AUD.
•  Is patient centered care needed?
•  The role of assessment
•  Setting goals through shared decision making
•  Pharmacological treatments
•  Psychosocial treatments
•  Summary & Conclusions

Patient-Centered Care (PCC)
Providing care that is respectful of and
responsive to individual patient preferences,
needs, and values, and ensuring that patient
values guide all clinical decisions.
Institute of Medicine, 2001
“No decision about me, without me”.

Defining attributes of PCC
•  Holistic
•  Individualized
•  Respectful
•  Empowering
Morgan and Yoder (2012)

Expected outcomes of PCC
•  Increased satisfaction with
health care
•  Greater perceived quality of
care
•  Increased commitment
•  Better compliance
•  Improved health outcomes.

Clinicians and patients should discuss:
•  ambivalence toward change;
•  patient goals (eg, abstinence vs decreasing drinking vs no
change);
•  preference for group based or individual psychosocial treatment
•  differences in the privacy and cost of the various options
•  medication treatments

Clinical
management

Assessment
Goal setting
Abstinence oriented Reduced drinking

AUD. Assessment dimensions.
DIMENSION DIAGNOSTIC CRITERIA
Drinking Quantity & Frequency
Tolerance & Withdrawal
Craving
Medical harm Continued use despite medical problems
Recurrent drinking (physically hazardous)
Behavioural Uncontrolled intake
Unsuccessful efforts to stop
Time spent around alcohol
Social harm Given up or reduced activities
Use despite social or interpersonal problems
Failure to fulfil major role obligations

Assessment of drinking patterns
•  Use Standard Drinks (8-10gr in EU)
•  Measure in grams/week
•  Ask quantity & frequency specifically
•  Ask for labour & weekend days separately
•  Identify binge drinking (>6 drinks pdo)
•  The ‘normal day’ strategy
•  Use standard tools whenever possible: AUDIT

Bio-psycho-social assessment (1)
Medical assessment (Why?)
•  Very high medical comorbidity
•  Improves adherence to treatment
•  Reduces stigma

Medical assessment (How?)
•  Physical examination
•  Blood tests (GGT, VCM, ASAT, ALAT, VHC, etc)
•  Focussed Anamnesis
–  Accidents
–  A&E and hospital admissions
–  Alcohol-related diseases

Psychological / Psychiatric Assessment
•  Alcohol related distress
–  Feeling guilty
–  Irritability
–  Insomnia
–  Antisocial behaviour
•  Psychiatric comorbidity
–  Depression
–  Suicidal behaviour
–  Anxiety disorders
–  Personality disorders

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

Social Assessment
•  Family status (divorce, ACOAs, etc)
•  Work (unemployment, unstability, etc)
•  Economical situation (debts, financial
problems, etc)
•  Educational level (lower degree than expected,
children with low qualifications)
Bio-‐psycho-‐social
assessment
(3)

How to do it
•  Empathic style
•  Avoid judgmental attitudes
•  Stick to facts. Do not discuss why.
•  Don’t ask just about alcohol. Tobacco, BZD
and illicit drugs are also relevant.
•  Try to understand the story and the dilemma
behind
•  Try to identify strengths of the patient

Clinical management
Assessment
Goal setting

Shared decision making
•  Helping patients better understand
their medical conditions;
•  Providing information about benefits
and adverse effects of treatment
options;
•  Supporting patients while they clarify
their values and preferences;
•  Providing support while patients
implement their decisions
•  working with family and caregivers
when patients have impaired
decisional capacities

Elwyn et al, 2014
Help patients
explore and form
their personal
preferences
Describe the
alternatives in
more detail (use
decision support
tools if appropriate)
Explain the need
to consider
alternatives as a
team
This strategy fits well with an integrated care approach

Clinical management
ASSESSMENT
Goal setting

DETOXIFICATION

Indicated
when:

•  Signs
or
symptoms
of
AW
are
present

•  PaEent
drinks
above
120gr
of
alcohol
daily

Not
indicated
when:

•  PaEent
is
absEnent
>72h
and
no
signs
of
AW
are

present

•  PaEent
does
not
agree
to
an
absEnence
goal

Clinical
Ins2tute
Withdrawal
Assessment

(CIWA)

•  Nausea
and
vomiEng

•  TacEle
disturbances

•  Tremor

•  Auditory
disturbances

•  Paroxysmal
sweats

•  Visual
disturbances

•  Anxiety

•  Headache,
fullness
in
head

•  AgitaEon

•  OrientaEon
and
clouding
of
sensorium

BENZODIAZEPINES
(BZD)

•  Long
half-‐life
BZD
are
preferred:
Diazepam
and

chlordiazepoxide
are
the
golden
standard

•  Loading
dose
Technique:
a
standard
dose
of
the
BZD
is

given
every
2
hours
unEl
light
sedaEon
is
reached.

•  Tapering
technique:
iniEal
dose
of
BZD
based
on

history.
Then
adjust
and
taper.

•  Lorazepam
and
oxazepam
are
indicated
in
paEents

with
impared
liver
funcEon

•  BZD
should
only
be
used
short
term
to
prevent
risk
of

addicEon

Timeline
followback
•  Retrospective
assessment of drinking
behaviour.
•  Reliable and valid for a
variety of populations
for time frames of up to
one year.
(Sobell & Sobell, 1992, 1996)

•  Avoid withdrawal signs
•  Treat comorbid conditions (mental & physical)
•  Accept and understand his disease
•  Reduce his desire & craving for alcohol
•  Reduce the priming effects of alcohol if drinking
•  Promote abstinence or reduction of alcohol
•  Improve coping skills
•  Improve quality of life
TREATMENT: Group of therapeutic processes
designed to help the patient to:
H

S

S

S

S

S

H

H

S
-‐
pSychosocial
H
-‐
pHarmacological

H

H
S

S

70
Alcohol useAbstinence - low risk - hazardous use - harmful use
-- dependence
Alcohol related
problems
Recommended psychosocial
interventions
Primary prevention -- Brief interventions --
Specialized treatment
Pharmacological
interventions

Widening the scope of
pharmacological treatments
•  Classical approach: Abstinence oriented
(disulfiram*, acamprosate*, naltrexone*,
topiramate)
•  Substitution therapy: BZD, sodyum oxibate,
baclofen
•  Reduction approach: nalmefene*, naltrexone,
topiramate, gabapentine.
* Registered indication

Target of Pharmacological
treatments
Goal Example
Decrease craving Acamprosate
Decrease priming Nalmefene
Decrease impulsivity Topiramate
Aversive reaction Disulfiram

45
Jonas, D. E., Amick, H. R., Feltner, C., et al (2014). Pharmacotherapy for
adults with alcohol use disorders in outpatient settings: a systematic review
and meta-analysis. Jama, 311(18), 1889–900. doi:10.1001/jama.2014.3628
Abstinence Oriented
Pharmacological treatments

•  Similar efficacy worldwide
•  Discontinuation of treatment lower in Europe
than in the rest of the world (acamprosate)
46

Efficacy of acamprosate in Japan
•  RCT in 327 Japanese patients with alcohol dependence
assigned to treatment with either acamprosate (1,998 mg/d
orally) or placebo for 24 weeks.
•  The primary endpoint was complete abstinence after 24
weeks of administration.
•  Acamprosate demonstrated superior efficacy vs placebo on
the primary endpoint: abstinence was 47.2% in the
acamprosate group compared with 36.0% in the placebo
group (P = .039).
48

Other drugs for abstinence oriented
treatments
Baclofen
•  Very controversial
•  Ongoing research just about to be published
•  Low doses are not effective. High doses likely to be
effective
Sodium Oxibate
•  Registered in Austria and Italy
•  Efficacy established for withdrawal
•  Main trial results confidential and shortly available

Reduced drinking
Pharmacological treatments
•  Nalmefene
•  Naltrexone?
•  Topiramate?
•  Gabapentin?

52
§  12-week, double-blind, RCT of naltrexone vs placebo in 221
individuals with AUD.
§  Participants randomly assigned to study treatment based on
the presence of 1 or 2 copies of the Asp40 allele compared
with those homozygous for the Asn40 allele (2  ×  2 cell design).
§  There was no evidence of a genotype  ×  treatment interaction
on the primary outcome of heavy drinking

Reduction of alcohol drinking in
young adults
•  A RCT conducted in an outpatient research center with 140 patients
aged 18-25, who reported ≥ 4 HDD in the prior 4 weeks.
•  Intervention: naltrexone 25 mg daily plus 25 mg targeted (at most
daily) in anticipation of drinking (n = 61) or daily/targeted placebo (n =
67). All participants received brief counseling every other week.
•  Primary outcomes were percent of HDD and percent days abstinent
over 8 weeks. Secondary outcomes included number of DDD and
percentage of days with estimated blood alcohol concentration (BAC)
levels ≥ 0.08 g/dL.
•  Percent HDD (21.60 vs 22.90) and percent days abstinent (56.60 vs
62.50) did not differ by group.
•  Naltrexone significantly reduced the number of DDD (4.90 vs 5.90; P
= .009) and percentage of drinking days with estimated BAC ≥ 0.08 g/
dL (35.4 vs 45.7; P = .042).
•  There were no serious adverse events.

Topiramate vs placebo at week 14th

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 2ESENSE 1
van den Brink et al. Alcohol Alcohol 2013;48(5):570–578; Data on file
MMRM (OC) FAS estimates 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

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 2ESENSE 1
MMRM (OC) FAS estimates 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

Putting the efficacy of psychiatric and general medicine
medication into perspective: review of meta-analyses
Leucht et al. Br J Psychiatry 2012;200:97–106
Nalmefene
standardised effect size range
Standardized effect size (Cohen’s d)
Nalmefene1 HDDs TAC
ESENSE 1 0.37 0.46
ESENSE 2 0.27 0.25
Alcohol
treatment2,3 0.12 to 0.33
Antidepressants4 0.24 to 0.35
Antipsychotics4 0.30 to 0.53
1. Data on file;
2. Kranzler & Van Kirk. Alcohol Clin Exp Res 2001;25:1335–1341;
3. NICE. CG115. Alcohol dependence and harmful alcohol use: appendix 17d –
pharmacological interventions forest plot. 2011;
4. Leucht et al. Br J Psychiatry 2012;200:97–106

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

MoEvaEonal
Interviewing

•  New
golden
standard
for
the
psychological

approach
to
addicEve
behaviours

•  Radical
change:

– external
confrontaEon
as
a
technique

vs
internal

confrontaEon
as
a
goal

– PaEent
centered

– Spirit:
partnership,
compassion,
evocaEon
and

acceptance

WR. Miller, S. Rollnick; 2012

Summary
•  Statistically significant,
modest but robust effect:
Odds ratio = 1.55
•  Effective: HIV viral load,
dental outcomes, death
rate, body weight, alcohol
and tobacco use, sedentary
behavior, self-monitoring,
confidence in change, and
approach to treatment.
•  Not particularly effective:
eating disorder and some
medical outcomes
Lundahl et al, 2013

A continuum of communication
styles …
73
Informing
Asking
Listening

… that depends on how we use our
communication abilities
Directing Guiding Following

Communication styles
74
Directing Guiding Following
Informing
Listening
Asking
Informing with
choices
Empathic goal -
oriented Listening
Asking open
questions
Informing
Empathic
listening
Asking

A continuum of styles
Goal Indications
Directing
Getting precise
information
Emergency
Making a diagnosis
Guiding
Eliciting and
reinforcing motivation
to change
Where there is some
ambivalence
Following
Letting them express
an emotional
experience
Emotional event
75

A Brief psychosocial approach:
BRENDA
Volpicelli JR, Pettinati HM, McLellan AT, O’Brien CP. Combining medication and psychosocial treatments for addictions; the BRENDA
Approach. New York, NY: The Guilford Press; 2001; Starosta et al. J Psychiatr Pract 2006;12:80–89
Needs expressed by the patient that
should be addressed
Direct advice on how
to meet those needs
Report to the patient
on assessment
Empathetic understanding
of the patient’s problem
Biopsychosocial
evaluation
Assessing response/behaviour of the
patient to advice and adjusting treatment
recommendations

77
Reduction in drinking using
Brenda & TLFB (Sense study)
ChangefrombaselineinHDDspermonth
ChangefrombaselineinTAC(g/day)
Monthly period Monthly period
HDDs TAC
Results from the control group

The Spirit of MI
Partnership
Collaboration
Acceptance
Evocation
Compassion
Spirit of
MI

Acceptance
Acceptance
Accurate

empathy

Autonomy

support

Aﬃrma2on

Absolute
worth

Basic skills
Open
questions
Reflective
listening
Information /
Advice
Affirming
Summarizing
80

Strategical approach to promote
behaviour change (4 basic processes)
Engaging
Focussing
Evoking
Planning
Miller & Rollnick; 2013

Summary & Conclusions
•  AUD
is
a
disease
highly
prevalent
and
with
important
medical,

psychiatric
and
social
comorbidiEes

•  Assessment
should
be
conducted
in
an
empathic
style,
from
a

bio-‐psycho-‐social
perspecEve
and
paEent
centered

•  Brief
intervenEons,
psychosocial
treatments
and
various
drugs

have
shown
eﬃcacy
in
the
treatment
of
alcohol
dependence

•  Combined
medical
and
psychosocial
treatments
are
the

preferred
treatment
strategy
for
alcohol
dependence,
within
an

Integrated
Care
approach

•  Integrated
Care
must
be
oﬀered
with
a
PaEent
Centered

approach,
which
implies
the
use
of
Shared
Decision
Making
in
a

moEvaEonal
style

84
Clinical strategies in the
management of alcohol
dependence
Antoni Gual
Addictions Unit
Psychiatry Dept. Neurosciences Institute
Hospital Clínic de Barcelona. IDIBAPS
tgual@clinic.cat
Thanks for your attention.
Questions are welcome.

Clinical strategies in the management of Alcohol Use Disorders. Lundbeck Institute, Copenhague march 2015

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Clinical strategies in the management of Alcohol Use Disorders. Lundbeck Institute, Copenhague march 2015