clinical strategies in the management of alcohol use disorders. lundbeck institute, copenhague march...
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Clinical strategies in the management of alcohol use
disorders Antoni Gual
Addictions Unit. Psychiatry Dept. Neurosciences Institute. Hospital Clínic de Barcelona. IDIBAPS.
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
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The case of Tom
Clinical Picture
Humanistic Picture
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
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
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
Bio-psycho-social assessment (1)
Medical assessment (How?)
• Physical examination
• Blood tests (GGT, VCM, ASAT, ALAT, VHC, etc)
• Focussed Anamnesis – Accidents – A&E and hospital admissions – Alcohol-related diseases
Bio-psycho-social assessment (2)
Psychological / Psychiatric Assessment • Alcohol related distress
– Feeling guilty – Irritability – Insomnia – Antisocial behaviour
• Psychiatric comorbidity – Depression – Suicidal behaviour – Anxiety disorders – Personality disorders
12.20 12.20
7,50
5.90
8,88
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
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
Clinical management
Assessment
Goal setting
Abstinence oriented Reduced drinking
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
Abstinence oriented Reduced drinking
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
Clinical management
ASSESSMENT
Goal setting
Abstinence oriented Reduced drinking
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)
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
• 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
Pharmacological treatments
70
Alcohol use Abstinence - low risk - hazardous use - harmful use -- dependence
Alcohol related problems
Recommended psychosocial
interventions Primary prevention -- B
rief interventions --
Specialized treatment
Pharmacological interventions
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Alcohol use Abstinence - low risk - hazardous use - harmful use -- dependence
Alcohol related problems
Recommended psychosocial
interventions Primary prevention -- B
rief 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)
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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).
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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?
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§ 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
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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.
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Topiramate vs placebo at week 14th
60
61
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Pivotal Nalmefene RCTs
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 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 2 ESENSE 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
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
Psychosocial treatments
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 …
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Informing Asking Listening
… that depends on how we use our communication abilities
Directing Guiding Following
Communication styles
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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
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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
11.60 11.60
7.50
5.40
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Reduction in drinking using Brenda & TLFB (Sense study)
Cha
nge
from
bas
elin
e in
HD
Ds
per
mon
th
Cha
nge
from
bas
elin
e in
TAC (
g/da
y)
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
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Strategical approach to promote behaviour change (4 basic processes)
Engaging
Focussing
Evoking
Planning
Miller & Rollnick; 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
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
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Clinical strategies in the management of alcohol
dependence
Antoni Gual Addictions Unit
Psychiatry Dept. Neurosciences Institute Hospital Clínic de Barcelona. IDIBAPS
Thanks for your attention. Questions are welcome.