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PATRICIA ALLEN Employed by SBH
MARIA ULMER Employed by SBH
Pharmacogentics Testing: Facilitating Engagement in the Treatment of Co-Occurring Disorders
Dr. Patricia Allen Maria Ulmer
Date of Activity: 9/16/2017
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Pharmacogenetic Testing
Facilitating Engagement in the Treatment
of Co-Occurring Disorders
Patricia M. Allen, DNP PMHNP-BC
Maria Ulmer, MA LMFT CAADC
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Offers personalized addiction services across a continuum of care in PA, NJ and MA
➢ Detox, residential, PHP, IOP, outpatient, family, community and alumni programs
➢ Co-occurring Disorders
➢ Eating Disorder Program
➢ Adults, Adolescents and Families
Summit Behavioral Health
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Objectives
1. Apply the principles of evidence-based practice and cost effectiveness in the utilization of genetic testing in the treatment of client with co-occurring disorders.
2. Determine relationship between the use of pharmacogenetics results and treatment engagement outcomes for those with co-occurring disorders.
3. Describe ways in which pharmacogenetic testing can empower the client and support sobriety and resiliency within the co-occurring population.
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Overview
➢Basics of pharmacogenetics testing
➢Criteria for testing
➢Case Studies
➢Interpreting the test for clients
➢Retrospective study results
➢Tools of recovery and engagement
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Pharmacogenetics & Drug Response
➢ Pharmacogenetics: the study of DNA sequence variation
➢ Includes drug metabolism, drug response as well as connect to OTC/herbal
➢ Genetic variations in drug-metabolizing enzymes can lead to adverse drug
reactions (ADRs) and therapeutic failure
➢ > 50% of U.S. population have gene mutations or variations
➢ 30 commonly prescribed drugs with high pharmacogenetic risk
accounted for 738 million prescriptions in 2013
Evan WE, McLeod HL. NEJM, 2003;348:538-549
Samer CF et al. Mol Diagn Ther, 2013;17:165–184
Ma Q, LU AYH. Pharmacological Reviews, 2011;63:437-459
Dunnenberger HM et al. Annu Rev Pharmcol Toxicol 2015;55:89-106
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Metabolizer Phenotypes
Phenotype Active Drug Prodrug*
Poor Metabolizer
(PM)
• Require lower dose to avoid side
effects and toxicity
• Lack of therapeutic response requires a
higher dose
Intermediate Metabolizer
(IM)
• May require lower dose to avoid side
effects and toxicity
• Lack of therapeutic response may
require a higher dose
Extensive Metabolizer
(EM)
• Standard dose appropriate • Standard dose appropriate
Ultra-Rapid Metabolizer
(UM)
• Requires higher dose to offset higher
rate of metabolism
• May require lower dose to prevent
excessive accumulation of active
metabolite
* Drug becomes active after CYP-mediated
metabolism
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Psychiatric drugs whose labels contain
PGx information include BUT ARE NOT LIMITED TO:
Alprazolam
Amitriptyline
Aripiprazole
Atomoxetine
Bupropion
Citalopram
Clomipramine
Clozapine
Desipramine
Diazepam
Doxepin
Escitalopram
Fluoxetine
Fluvoxamine
Iloperidone
Imipramine
Mirtazapine
Modafinil
Nefazodone
Nortriptyline
Olanzapine
Paroxetine
Perphenazine
Pimozide
Protriptyline
Risperidone
Sertraline
Thioridazine
Trimipramine
Venlafaxine
Several of these drugs have a boxed warning,
which is the FDA’s most serious type of medication labeling.
The FDA labeling for these drugs includes warnings and precautions based upon PGx information which may be associated with dose adjustments, risk for adverse events, or clinical response variability.
cpicpgx.org
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Treating Psychiatric Disorders: Trial & Error
Numerous medications are available for the management of psychiatric disorders,
such as anxiety, depression and PTSD.
However,
➢ Many patients do not have symptom relief yet they suffer from side effects
➢ A patient may start an anti-depressant and not be seen for a follow-up
appointment for as long as 4-6 months
➢ As a result, patients frequently stop their medication due to lack of efficacy or
side effects which significantly increases the risk of harm or suicide
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The STAR*D Study is a Landmark Study
Demonstrating the Impact of Treating Depression
33%
57%63% 67%
100%
50%
0%
Baseline After 1st
Treatment
After 2nd
Treatment
After 3rd
Treatment
After 4th
Treatment
* Remission, or complete recovery from depression, was defined as a score of 7 or less on the 17-item Hamilton Rating Scale for Depression (HAM-
D17)Gaynes BN, Rush AJ, Trivedi MH et al. Clev Clin J Med. 2008;75:57-66.
Pro
po
rtio
n o
f p
atie
nts
wh
o
ach
ieve
d r
em
issio
n
• In the STAR*D study, patients with depression were treated with Celexa for 14 weeks (1st)
• Patients who did not achieve remission* were changed to a new treatment strategy (2nd)
• Patients who still did not achieve remission (after a 14-week trial)
could try up to 2 additional successive treatment strategies (14 weeks each 3rd and 4th)
67% of patients did not
respond to citalopram
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Co-Occurring Disorders
➢ Over 65% of SUD are co-occurring
➢ Substance Use Disorders are often accompanied by MDD, BAD, GAD
➢ 70-75% of Summit Behavioral Health’s patients present with co-
occurring disorders across the continuum of services
➢ Identification, treatment and engagement are critical for long term
recovery outcomes
➢ Recovery tools - MAT and Pharmacogenetics testing
NIDA,
2015
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Delivery of Client Centered Treatment
➢ Personalized treatment starts with the clinical biopsychosocial
assessment
➢ Pharmacogenetics testing
➢ Medication Assisted Treatment
➢ Family involvement
➢ Quality of life
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Tools of Engagement
➢ Integrative treatment approach
➢ Cohesion, collaboration and coordination
➢ “TEAM”
➢ Environment
➢ Trust
➢ Safety
➢ Sense of community
➢ Therapeutic strategies
➢ Person-centered
➢ Comprehensive assessment and evaluation … reevaluation
➢ Diverse Therapeutic Modalities
➢ Pharmacology and Pharmacogenetics
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So… what works?
➢ “Meet them where they are”
➢ Everything and the Kitchen Sink
➢ Evidence-based and Measurable
➢ Creative and Innovative
➢ Breath of Hope
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Summit: The Forefront of Addiction Treatment
When presented with the idea of PG testing, we recognized the opportunity to
offer cutting-edge and medically driven resources that truly exemplified
individualized care.
➢ Nearly 4 years of testing
➢ Stats, 2016 132 tests (one location) over one year period
➢ Of those 132 clients 44% had gene variances
➢ 18 genes analyzed, 8 mutations per client
➢ Prozac, Lexapro, Seroquel and Motrin most common variation
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Cost
➢ Covered by insurance companies
➢ Typical financial aid
➢$25-$200
➢ Look at client’s income vs family
➢ Option of cash payment
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Performance Improvement
The journey from anecdotal case studies
to Retrospective Review.
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Case Study 1
➢ Client is a 23 year old single male living with parents
➢ Opiate Use Disorder, Cocaine Use Disorder, MDD and GAD
➢ DOC: Heroin - 10 bags daily
➢ Polysubstance abuse from the age of 12
➢ Longest period of sobriety 7 months
➢ Supportive family
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Interpreting Test Results
CYP1A2 IM slightly lower drug metabolism
CYP 2C 19 UM rapid drug metabolism → → decrease therapeutic response
CYP3A5 PM very slow metabolism → → increase drug toxicity
HTR2A serotonin receptor mutation → → impacts medication response
HTR2C
COMT
MTHFR 677C methylation → →
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APPLICATION
➢ Stopped Lexapro
➢ Started
➢ Neurontin (discontinued after 6 months)
➢ Wellbutrin XL 150 mg
➢ Vistaril 25 mg BID prn (was 50 mg and TID)
➢ Seroquel 100 mg for sleep (discontinued at 9 months)
➢ Stopped smoking
➢ Stopped ginseng Red Bull
➢ Stopped grapefruit juice
➢ Initiated Vivitrol, committed to 12 months completion
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➢ Sober 19 months sober
➢ Mood stabilized
➢ “I never thought any medication would help me, I have more energy, my mood is
even and I’m getting my life on track”
➢ Accepted in a graduate program for fall
➢ Back to work
➢ “I bought a boat, that wouldn’t have happened if I were still using”
➢ Remains engaged in aftercare: individual, aftercare group (weekly)
➢ AA, sponsor, commitments
➢ Yoga
Treatment Outcomes
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➢ The client is a 25 year old single female living in a sober living home
➢ Dx: Opiate Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder, MDD,
GAD, ADHD.
➢ Trauma history including near death alcohol OD at 14, sexual abuse
➢ History of SI, SIB: cutting and burning
➢ Tx hx: Rehab, residential, mental health inpatient, PHP, outpatient
Case Study 2
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Interpreting Test Results
CYP1A2 UM rapid drug metabolism → → decrease therapeutic response
CYP 3CA4 IM slightly slower drug metabolism → → adjust dose
CYP3A5 PM very slow drug metabolism → → increased risk of drug toxicity
COMT A/A impacts mood regulation, associated with efficacy of ADHD meds
MTHFR 677C methylation → → important for neurotransmitter production,
homocysteine levels
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APPLICATION
➢ Stopped Seroquel
➢ Stopped Trazodone
➢ Continued Lamictal 200 mg BID
➢ Lowered Lexapro 10 mg
➢ Increased Neurontin 600 QID
➢ Added Remeron 7.5 mg
➢ Added pre-natal vitamin
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Treatment Outcomes
➢ Sober over 18 months
➢ Longest sobriety was 90 days while in inpatient treatment
➢ Mood stabilized
➢ No SI, SIB
➢ Working
➢ Active in AA, sponsor, taking commitments
➢ Engagement increased throughout recurrence of symptoms
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➢ Determine if stabilization of the co-occurring opiate and mental health disorder
supports engagement and abstinence
➢ To identify and support best practices leading to sustained engagement and
abstinence
➢ Overall goal of identifying best practices in the care of those we treat with co-
occurring disorders
Performance Improvement Project
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➢ Retrospective analysis
➢ MAT
➢ Engagement, sobriety
➢ Pharmacogenetics testing
➢ Stabilization
➢ Preliminary results
➢ Engagement at 30, 60 , 90 days
Outcomes
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➢ 12 months period of time
➢ Males and females 18 or older admitted to outpatient continuum primary
opiate use disorder
➢ Clients with a co-occurring psychiatric disorder in addition to the opiate
addiction were included in the sample.
➢ Exclusionary criteria include clients with a primary mental health disorder as
well as any client with a severe mental health disorder.
➢ Clients with a primary diagnosis other than opiate use disorder were excluded.
Retrospective Review
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Outcomes of Clients with Co-Occurring Disorders and ID Genetics Testing
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MAT at 30, 60 and 90 Days
Results
90 Days
60 days
30 Days
Suboxone Vivitrol No MAT
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Results
MAT Breakdown
78 clients
received
No MAT
30 clients
were treated
with Suboxone
50 clients
were treated
with Vivitrol
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Summary of Findings
➢ Clients receiving MAT (65%) remained engaged longer than those not
receiving MAT 37%).
➢ Clients using Vivitrol were nearly equal with Suboxone.
➢ Clients with co-occurring disorders who benefited from pharmacogenetics
testing remained engaged longer than those without guided treatment
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Next Steps
➢ Continue evaluation of data: characteristics of those with sustained
engagement as well as those that fell off during the 1st 90 days.
➢ Evaluate aspects of engagement
➢ Expand data collection to include evaluation at 12 months
➢ Continue to incorporate SBH values of providing client centered,
innovative, holistic and evidenced-based treatment to support
engagement and recovery.
➢ Reduce the long standing stigma of substance dependence and mental
illness, empowering the client
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Without Engagement
there can be no Best Practice.