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The Challenges of Dissemination: Your Role in the Development of Addiction Medicine Specialists

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Title: The Challenges of Dissemination: Your Role in the Development of Addiction Medicine Specialists


1
  • The Challenges of Dissemination Your Role in the
    Development of Addiction Medicine Specialists

Margaret M. Murray, Ph.D. Director, Global
Alcohol Research Program National Institute on
Alcohol Abuse and Alcoholism
2
No
3
National Institute on Alcohol Abuse and
Alcoholism (NIAAA)
  • Mission To understand how alcohol use impacts
    normal and abnormal biological functions and
    behavior across the lifespan and at all levels of
    drinking including
  • Alcohol-associated disease (including alcohol
    dependence)
  • Alcohol-derived organ pathologies
  • Public health problems resulting from acute and
    chronic alcohol use (e.g., alcohol poisoning,
    accidental injury and death)
  • Thereby improving the health and well-being of
    not only of those in the US but also of others
    around the world

4
  • Why do we need specialists in addiction medicine?
  • Alcohol problems are a significant global health
    problem, including in the United States.
  • Alcohol problems are complex and require
    specialists to ensure to the best comprehensive
    patient care.
  • Evidence based prevention and treatment exist,
    but need to be expanded, refined, and effectively
    disseminated by adequately-trained experts.

5
Harmful Drinking The Present Global Challenge
As a percentage of all risk factors that cause
ill health, alcohol ranks high in many parts of
the world.Science 16 May 2008Vol. 320. no.
5878, pp. 862 - 863
6
The United Nations General Assembly on the
Prevention and Control of Non-communicable
Diseases Political Declaration
  • The first time that all Member States of the
    United Nations agreed to come together and
    develop an agenda to reduce the risk of NCDs (UN
    General Assembly Resolution 66/2, 2011).
  • Reduction in the harmful use of alcohol has been
    identified as one of the four behavioral measures
    countries must focus on as part of the global
    plan to reduce this risk.

7
Harmful Drinking is a Leading Risk Factor for
Disease Burden in the U.S.
  • 18 million Americans (8.5 of the population age
    18 and older) suffer from alcohol abuse or
    dependence
  • Alcohol problems cost U.S. society an estimated
    185 billion annually
  • Alcohol consumption is among the top ten leading
    causes of DALYs
  • Among Actual Causes of Death Alcohol ranks 3rd
    with an estimated 79,000 deaths annually for
    2001-2005

Disability-adjusted life years (years of
potential life lost due to death plus years of
healthy life lost to disability)
8
A Developmental Perspective Past Month Alcohol
Use, Binge Drinking (5) and Heavy Drinking (5
drinks 5 or more times)
9
Maternal Alcohol Use during Pregnancy by
Country
The ranges are inclusive of any amount of alcohol
consumed and at any point during pregnancy The
upper estimate 85 Denmark (92) Finland
(90) Ireland (89) SA (87) Russia (85) The
lower estimate lt5 Israel (1.1) Taiwan and the
US (1.4) Japan (4.6)
Popova,S. University of Toronto
10
Epidemiology Prevalence of Fetal Alcohol
Syndrome (FAS) and partial Fetal Alcohol Syndrome
(pFAS) in School Entry Students via Active Case
Ascertainment
Location (Reference Year) Population Socioeconomic Status FAS (FASpFAS) Rate per 1000
United States Mid-Western Medium Size City (May et al. 2009) 75 white 25 AI, Af. A, and Asian Middle SES with full range -low to Upper 6 11 (14 25)
Italy Lazio Region (May and Ceccanti, 2007) Predominantly white Middle SES 4 9 (27 55)
South Africa Western Cape (2007) 85 Mixed Ancestry, 15 European White Low Middle SES White Middle Upper SES 51 67 (68 90)
South Africa Northern Cape (Urban et al. 2008) 64 Mixed Ancestry 36 Native Black Low Middle SES 67 (75 119)
IOM 1996 prevalence estimated in U.S. for FAS at
0.5 2 /1000
11
Frequency of Risk Drinking in U.S. Population
  • NIAAA has defined risk drinking as exceeding
    5/4 per day (14/7 per week) based on
    epidemiologic data from the NESARC and
    probabilities of an adverse outcome at various
    drinking levels
  • 65 of the U.S. adult population are current
    drinkers
  • 59 of current drinkers do not report risk
    drinking

12
Two Distinct Patterns of Drinking Produce the
Most Harm
Binge Drinking (too much, too fast) 5/4
drinks/2 hours
Heavy Drinking (too much, too often) frequent
5/4 drinks/day
  • chronic consequences including
  • liver cirrhosis
  • cardiovascular diseases
  • pancreatitis
  • dementia
  • alcohol dependence
  • acute consequences including
  • unintentional death and injury
  • homicide and violence
  • suicide attempts
  • particularly prevalent among adolescents and
    young adults

13
Between Individual Variations in Responses to
Alcohol(Why drink Drink more Drink despite)
  • Pharmacokinetics absorption, distribution, and
    metabolism of alcohol
  • 3-4 fold
  • Pharmacodynamics subjective and objective
    responses to alcohol
  • 2-3 fold

About one-half of these differences is
genetic. No single treatment intervention works
for all.
14
Heterogeneity of Treatment Populations Severity
15
Many Psychiatric Conditions Co-occur withDSM-IV
Alcohol Dependence
16
McGlynn EA et al. N Engl J Med 20033482635-2645.
17
(No Transcript)
18
  • Clinical Trials in the Last Fifteen Years Have
    Shown
  • Different kinds of behavioral therapies work
    equally well (e.g., motivational enhancement,
    cognitive behavioral, 12-steps)
  • Medications with Medical Management works and
    potentially can be used in primary care settings

19
Developing Medications for Alcohol Dependence
20
Screening ModelsValidation Process
Bidirectional Integration
Human Laboratory Models
Molecular Targets
Animal Models
Clinical Trials
  • Pharmacogenetic Research
  • Collaborative Networks with Industry and Academia

21
  • Targets for Alcohol Dependence
  • Many potential target sites have been identified
    for the actions of alcohol.
  • This is not surprising given that alcohol is a
    small molecule (MW46) that readily crosses the
    blood brain barrier As well as cell membranes
    given alcohols polar and hydrophobic properties.

22
  • NIAAA-Supported Human Laboratory Studies

Medications Target

PF-05190457 (ghrelin antagonist) GHS
ibudilast phosphodiesterase
guanfacine (Tenex) ß2 adrenergic
mecamylamine (Inversine) nicotinic
LY686017 NK1
Pexacefront, GSK 561679 CRH1
aripiprazole (Abilify) D2, 5-HT1A, 5-HT2
23
  • Human Laboratory Studies

Medications Target

fenofibrate PPAR a
prazosin a1 adrenergic





24
  • NIAAA-Supported Clinical Trials Phase II Trials

Medications Target

baclofen (Lioresal, Liofen) GABAB
pregabalin (Lyrica) glutamate/GABA
oxytocin topiramate oxytocin glutamate/GABA
zonisamide (Zonegran) glutamate/GABA
gabapentin (Neurontin) glutamate/GABA
ondansetron (Zofran) serotonin 5-HT3
duloxetine (Cymbalta) 5-HT, NE transporter
olanzapine (Zyprexa) D1-4, 5-HT2A, 5-HT2C
doxazosin a1 adrenergic
prazosin (Minipress, Vasoflex and Hypovase) a1 adrenergic
varenicline (Chantix) nicotinic a4ß2
dutasteride (Avodart) mifepristone 5-a reductase glucocorticoid
25
  • NIAAA-Supported Clinical Trials
  • Phase II

Medications Target


oxcarbazepine Na channel
citicoline phospholipase A2 ?
mirtazapine 5-HT2/3 and a1 adrenergic
naltrexone opioid






26
  • NIAAA-Supported Clinical Trials
  • Phase II

Medications Target


Ondansetron topiramate
varenicline prazosin naltrexone memantine (lab study)
valproate naltrexone








27
Personalized medicine is complex
  • Combination of Factors
  • Genome, transcriptome, epigenetic modifications
  • Physiological/biochemical indicators
  • Individual patients characteristics
  • Cultural indices
  • Family history

28
Future Research Developing Personalized Medicine
29
Allele Variants Relevant toSpecific Medications
  • Pharmacogenomic Advances
  • Medication Genetic SNP Site
  • naltrexone A118G OPRM1
  • ondansetron LL5/ - HTTLPR
  • TT rs1042173 AG rs 1150226 GG
    rs1176713
  • AC rs17614942
  • topiramate CC rs2832407

30
Key Objectives for Next Decade
  • Identify and validate new molecular targets
  • Develop and implement screening models using
    animal models and human laboratory paradigms
  • Bridge gaps in the drug development process
  • Conduct clinical trials more efficiently using
    enhanced methodology and facilitation of proof of
    concept trials
  • Advance personalized medicine in pursuit of new
    therapeutics
  • Facilitate adaptation of alcohol medications in
    treatment settings
  • Facilitate collaborative networks and
    partnerships among government, academia,
    pharmaceutical/biotechnology companies,
    healthcare organizations, and advocacy groups

Litten et al., Addict Biol 17513-527, 2012
31
NIH Approaches to Dissemination and
Implementation Science
  • There is a need for research testing approaches
    to scaling up and sustaining effective
    interventions, and we propose that further
    advances in the field will be achieved by
    focusing dissemination and implementation
    research on five core values
  • Rigor and relevance
  • Efficiency
  • Collaboration
  • Improved capacity
  • Cumulative knowledge

32
Definitions of Dissemination and Implementation
Research
  • Dissemination research is the systematic study of
    processes and factors that lead to widespread use
    of an evidence-based intervention by the target
    population. Its focus is to identify the best
    methods that enhance the uptake and utilization
    of the intervention .
  • Implementation research seeks to understand the
    processes and factors that are associated with
    successful integration of evidence-based
    interventions within a particular setting (e.g.,
    a worksite or school). Implementation research
    assesses whether the core components of the
    original intervention were faithfully transported
    to the real-world setting (i.e., the degree of
    fidelity of the disseminated and implemented
    intervention with the original study) and is also
    concerned with the adaptation of the implemented
    intervention to the local context .
  • Rabin BA, Brownson RC, Hiare-Joshu D, Kreuter MW,
    Weaver NL A glossary for dissemination and
    implementation research in health.
  • J Public Health Manag Pract 2008, 142117-123.

33
  • What is the impact of your Medical Education
    efforts?
  • Is there an increase in teaching about
    alcohol/addiction?
  • Is there an increase in teaching confidence?
  • Are physician attitudes, skills and knowledge
    being improved?
  • Are patients being screened and identified as a
    result?
  • Are patient outcomes affected?

34
Your role?
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