Treatment Track: Inpatient and Outpatient Treatments for Pain and Addiction

1. Treatment Track:
Inpatient and Outpatient Treatments
for Pain and Addiction
Presenters:
• Amanda Wilson, MD, MS, Founder and CEO, CleanSlate
Addiction Treatment Centers
• Margaret Jarvis, MD, FASAM, Medical Director, Marworth
Alcohol and Chemical Dependency Treatment Center
• Andrew B. Mendenhall, MD, Outpatient Medical Director,
Hazelden Betty Ford Foundation
Moderator: Carla S. Saunders, NNP-BC, Advance Practice
Coordinator, Pediatrix Medical Group, and Neonatal Nurse
Practitioner, East Tennessee Children’s Hospital, and Member,
Rx Summit National Advisory Board

2. Disclosures
• Amanda Wilson, MD, MS, has disclosed no relevant, real or
apparent personal or professional financial relationships with
proprietary entities that produce health care goods and services.
• Margaret Jarvis, MD, FASAM – Employee: Geisinger Health System;
Royalties: Up-to-Date; Stockholder: US Preventive Medicine Inc.
• Andrew B. Mendenhall, MD, has disclosed no relevant, real or
apparent personal or professional financial relationships with
proprietary entities that produce health care goods and services.
• Carla S. Saunders, NNP-BC – Speaker’s bureau: Abbott Nutrition

3. Disclosures
• All planners/managers hereby state that they or their
spouse/life partner do not have any financial
relationships or relationships to products or devices
with any commercial interest related to the content of
this activity of any amount during the past 12 months.
• The following planners/managers have the following to
disclose:
– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
– Carla Saunders – Speaker’s bureau: Abbott Nutrition

4. Learning Objectives
1. Compare inpatient and outpatient treatment
options for addiction.
2. Identify components of effective inpatient
and outpatient treatments for addiction.
3. Advocate strategies to improve delivery of
this treatment method.

5. Inpatient and Outpatient Evidence Based
Treatments for Pain and Addiction

6. Disclosure Slide
Amanda Wilson, M.D. has disclosed no relevant, real, or apparent
personal or professional financial relationships with proprietary entities
that produce health care goods and services.

7. Amanda Wilson, M.D.
President and CEO of CleanSlate Centers
Diplomate of ASAM
Winner of the 2012 SAMHSA Science and Service Award
for Office-Based Opioid Treatment

8.  Substance use disorders, especially to opioids,
alcohol, and tobacco, drive enormous morbidityand
mortality
 Opioid addiction is epidemic
 Lack of high quality,cost effective treatmentburdens
not only patients,but all stakeholders

9. Medication Assisted treatment for Opioid Dependence
Maintenance
treatment is the
most clinically
effective, and
cost effective
treatment
HHS, CDC, NIDA,
TRI, ASAM, ICER
agree
Decreased
morbidity and
mortality
Decreased total
costs of
medical/BH care
Decreased costs
of incarceration,
issues with
employment
presenteeism
and absenteeism

10. Barriers to providing this care: Lack of prescriber
resources
Lack of comfort treating population
30/100 patient limit for buprenorphine
DEA involvement
Lack of familiarity with Buprenorphine
and IM Naltrexone
Operational infrastructure needed

11. High quality, evidence based, cost effective care
requires:
Full patient
assessment
Active
treatment
planning
Appropriate
counselling
Diversion control
protocols
Attention to
costs of care
Continency
management
Coordination of care
with medical and BH
providers, and
appropriate referral and
access to the continuum
of care

12. Addiction Physician Leaders at CleanSlate
 All have or are becoming ABAMCertified
 Conduct weekly discussionswith midlevelstaff at each site regarding challengingcases
 Provide case by case guidance
 Reviewall patient discharges
 Participatein a monthly Physician Leadership quality meeting
 Supervise and educate part time physicians
 In MA, these are PCP’s; modificationsin program willoccur as required for local conditions

13. Early Treatment – Stabilization
 Patients are seen and counseled by a doctor/ advanced practice clinician on their
current treatment plan
 Stabilization can take as long as 3-6 months for many patients
 Patients are generally induced in the office to ensure they learn to take the medication
properly
 A clinician goes over the requirements/expectations/goals of the program
 Patients are seen weekly until they have stabilized
 This can be monitored by a combination of random call backs, appropriate UDT,
Film/film wrapper and pill counts, demonstration of compliance with BHattendance
 If a patient repeatedly struggles with the requirements of the program and/or are
suspect of diversion patient is referred to higher level of care
 If patient misses a scheduled appointment, our retention specialists follow up with the
patient to find a time for them to return

14. Program Outline: Care/Treatment Plans
Protocol Discussion –
• Opioid Treatment Protocol
• Tobacco Cessation Protocol
• Alcohol Outpatient Detox and Tx Protocol
• Benzodiazepine Taper Protocol
Updated Quarterly and Annually
Include assessment of other medical and
BH needs and coordination of care

15. Program outline: intensity of care and contingency
management
Assessing how the patient is
progressing with treatment,
according to the CleanSlate
protocol, they are categorized
into four categories (Red,
Orange, Yellow, and Green)
 Categories provide a quick indicator of patient
clinical stability
 Categories determine:
 Frequency of Clinical Visits
 Intensity of Behavioral Health Support
 Frequency of Urine Drug Screening, Randoms
 Necessity of any Definitive Drug Screening
 E.g. Buprenorphine Metabolite (Norbup)
 Advancement in Plan of Care
 Thus Outpatient care can be intensified as the
patient requires depending on patient stability and
severity of addictive illness
 Adjustments made to patient care throughout
Maintenance Phase, patients may need to re-
stabilize after any relapse
 Duration of Maintenance Phase is individualized
and based on patient history and compliance

16. Diversion Precautions
 Use of PDMP
 Coordination of care
 Frequent Use of Urine Drug Screening, supervised when
necessary
 Use of random screens, and call backs
 Frequency of clinical and behavioral appointments
 Patients required to bring in wrappers and unused films
/tabs for counts
 Lot numbers (when available) recorded for confirmation
with Pharmacies in suspect cases
 Bup/Norbup levels on urines to assure metabolite is
present, at random urines and periodically, diversion is
suspected

17.  Upon arrival at a CS location, patients are asked to provide a urine sample
in a secure bathroom facility
 (If necessary, this will be supervised to ensure validity of the
specimen)
 Urine samples are randomized by type of testing done and by call back
system
 Not every sample obtained is tested
 Frequency of urine testing is based on clinical stability and previous results
 All urine samples are shipped to the centralized high complexity laboratory
where qualitative (presumptive) lab analysis is performed
 ImmunoAssay screening is generally all that is required
 Additional screening/definitive testing (LCMS) is done rarely, and when
confirmation will change plan of patient care
 Metabolite confirmation is done more often to mitigate risk of diversion

18. Quality of Care
SAMHSA SCIENCE AND SERVICE AWARD
WINNING PROGRAM
CARF Accreditation of all centers,
Joint Commission Standard of
Credentialing Providers
Quality/Risk Management
team
Clinical and Operational
site visits
Regional medical directors
conduct Chart Audits for
clinical performance &
documentation feedback,
external audits requested and
performed annually
EMR monitoring allows
dashboards ensuring appropriate
frequency of care, and adherence
to clinical guidelines

19. Specialized Services:Hepatitis C Treatment
CleanSlate patients have a 555%
reduction in becoming Hep C+ in just
the first year of treatment
Newer medications available for
treatment, partnership with Beth
Israel Deaconess/Harvard
Completely oral regimen 95% success
with CURE
25% of patients with IVDU history
become Hep C Positive in first year
All patients screened for Hep C at
initiation of treatment
Liver enzymes followed95%
25%

20.  Part of the ongoing TreatmentPlans
 Enable followingof “Outcomes that Matter” defined by
SAMHSA
 Employment/EducationalActivities
 OverallHealth
 Financial Stability
 Home/RelationshipStability& Safety
 Parenting
 Ongoing Legal Issues

21. CleanSlate uses a compassionate
accountability model of care and “meets the
patient where they are.” Based on discussions
with industry experts, we believe this model is
differentiated in the market by its high touch,
outcomes and compliance driven clinical and
business processes
Philosophy in Practice
• Harm Reduction Model
• Patients are not discharged for continued use initially, but care is intensified
• Motivational Interviewing is widely utilized to motivate patients
• Contingency management with rewards for success jave been successful
• Patients earn the right to have less frequent visits as they stabilize
• Refer patients for higher level of care if intensive outpatient medical and
behavioral support is insufficient
• Patients develop life-sustaining critical relationships with their physician and
mid-level providers, and they are held accountable in a compassionate way for
treatment compliance, which has driven patient success
• Patients are apprised at the start of treatment that it is the ultimate goal of the
treatment plan to work with them toward total abstinence from all abuse-able
substances
• Meet the patients where they are, individualize treatment
• Keep Patient’s engaged, Longer retention in treatment improves outcomes
CleanSlate believes strongly that
addiction is a chronic brain
disease best cared for with a
combination of Medication
Assisted Treatment, and
Behavioral Health Interventions
Clinical Treatment Philosophy

22. Outcomes Management Leads To Greater Long Term Retention
Positive Outcomes
DO NOT EQUAL
Just Negative Urines
“Outcomes that Matter”
 Current Employment
 Advancing Education
 Actively Treating Mental Illness
 Actively Treating Medical/Surgical Diagnoses
 Financial Stability
 Home/Relationship Stability
 Actively Parenting Children
 Resolved Criminal Charges
 Confirmed Counseling/12-Step Attendance
Current Patient Retention
• 62% patient retention at 1 year
– 50% at 2 years
– National average is 29% retention at 6
months; 19% at one year
• Commonly used marker for success
• Patients who need to be progressed to
higher levels of care referred appropriately

23.  All patientsreviewed to ensure that patientswho “no show” are
calledand encouraged to return for next visit
 All patientswho don’t reschedule are called to return
 Patientsnot retainedwho are completelyunable to maintain
sobriety are progressed to higher levelsof care
 No patientleft behind
 On average 1% per month are discharged, generally for diversion
 Patientswant to get well; they stay when they have good
outcomes

24. CleanSlate: The Future
Adding additional
centers and nodal
expansion into
new states
Collaborate with
providers, payers,
other stakeholders
(Criminal justice,
MCOs, Health
Care Homes,
Behavioral Health
Providers)
Expanding types
of treatment
service,
Ex. Hep C
Research on
outcomes and
best practices,
Development of
Addiction
Fellowship with
Brown University
Improving the
well-trained work
force, expand
public awareness
of the epidemic
and treatment
options

25. Residential Care
Margaret Jarvis, MD
Marworth Treatment Center
Geisinger Health System

26. Margaret Jarvis, MD wishes to
disclose:
• Contributor to UpToDate
• Stockholder in US Preventive Health Inc

27. Objectives
• Learning Objectives:
– Compare inpatient and outpatient treatment
options for addiction.
– Identify components of effective inpatient and
outpatient treatments for addiction.
– Advocate strategies to improve delivery of this
treatment method.

28. What am I talking about?

29. Elements of ASAM Level 3.7 Care
• Usually freestanding facility
– Admissions screened by licensed or certified staff.
• Medical and psychiatric conditions discussed with MC
prior to admission
• Stumbling blocks to safe discharge identified prior to
admission
• Specialty unit in general or psychiatric hospital
– Overhead expenses
– “institutional” feel

30. Marworth
• 91 beds
• 21 “detox” beds
• On 20 acres, about 30
minutes from nearest
hospital
• Much attention paid to
cleanliness, safety,
respect, “homey” feel

31. Elements of ASAM Level 3.7 Care
• Physician and nursing care and monitoring
available. H&P’s to be done within 24 hours
of admission
– Physicians on site during day and available by
phone. Certified in Addiction
Medicine/Psychiatry.
– Addiction Medicine Fellowship on campus
– 2 mid-levels

32. Elements of ASAM Level 3.7 Care
• Nursing on site 24/7
– Full nursing assessment done at admission
– Nurses with experience in withdrawal assessment
and monitoring critical

33. Elements of ASAM Level 3.7 Care
• Lab services, x-ray, medical specialty,
psychology on site or by referral
– Dental
– Screening for psychiatric and medical problems
– Behavioral compulsions addressed
• Psychiatric services available within a short
time

34. Elements of ASAM Level 3.7 Care
• Interdisciplinary staff understands psychiatric
and substance abuse
– Weekly treatment team meetings
– Daily staff meetings
• Individualized treatment plan with patient
• Counseling with evidence-based techniques
• 24 hours professionally directed evaluation,
care, treatment

35. Elements of ASAM Level 3.7 Care
• Therapies are evidence-based psychotherapies
and medications
– Oral and depot injected naltrexone, other anti-
craving medications
• Highly structured 6am to 11pm
• UDS at admission and randomly, other
bioassays
• Health education
• Family education and counseling weekly

36. Marworth
• Diversion control/contraband control: This
level of restriction not feasible on outpatient
basis
– Observed medication with mouth checks
– Few “keep on person” meds
– Constant discussion of new abused medications
and chemicals
– No sleepers or prn anxiety medication

37. Marworth
• Diversion/contraband control
– “Personal search” on admission
– Luggage scanned
– Dog inspections

38. Inpatient and Outpatient
Treatments for Addiction:
A Comprehensive Opioid
Response
Andrew Mendenhall M.D.
Outpatient Medical Director
Hazelden BettyFord Foundation

39. Disclosures
• Dr. Mendenhall works for the Hazelden Betty
Ford Foundation.
• Dr. Mendenhall no commercial or financial
disclosures.

40. Learning Objectives
1. Compare inpatient and outpatient treatment
options for addiction.
2. Identify components of effective inpatient
and outpatient treatments for addiction.
3. Advocate strategies to improve delivery of
this treatment method.

41. The Hazelden Betty Ford Experience
• Increased admissions for opioid use disorders
– Adults: 19% (2001)  30% (2011)
– Youth: 15% (2001)  41% (2011)
• Problems with treatment retention
– Significant rate of ASA discharge
– Risk to patient  Nearly all of these patients leave
treatment to relapse
• Unit milieu issues
• Use of opioids during treatment
• Increased incidence of death following treatment
– Ethical imperative to evaluate the treatment model.

42. COR-12: Comprehensive Opioid
Response and the 12-Steps
• An integration of 12-Step Recovery Programming
with:
– Opioid specific support groups
– Medication Assisted Treatment
– Residential  Outpatient continuum
• Response to patient and health delivery system
need.
– Ethically driven to help more patients
achieve long-term Recovery.

43. The Need: Help more people access and stay in treatment

44. A diversity of opioid use disorders
1. Young population of opioid addicts  early
substance use with alcohol, cannabis and pills
• Progress to smoked or IV heroin before completion of
brain development
2. Older population of opioid addicts 
prescription opioids
• Often with benzodiazepines, hypnogogics and/or
alcohol
• Co-occurring pain issues are common
*Universality of the chemical brain lesion*

45. The chemical brain lesion
Considering “Salience”
– Definition: The state of being prominent or important.
– Practically: The conscious manifestation of craving for a
drug of choice.
• “Opioids generate a state-of-mind perhaps paralleled only by
the highest of spiritual experiences while simultaneously
disallowing any tolerance for even the slightest discomfort.
This complicates the patient’s ability to remain in treatment
or to be available for developing new relationships and
acquiring new information.”
– Fred Holmquist M.A., LADC Director Hazelden Lodge
Program
A Drug is a Drug is a Drug….. And then there are opioids…….

46. Opioids are Neuroinflammatory and activate
Glial Cells: Gliopathic Pain and Mood
dysregulation
• Receptor pathways:
– 1. Morphine activates TLR4 (toll-like receptors) and activates the
TLR-MD-2 complex.
• Direct Metabolite pathways:
– Oxidative stress via NADPH/NOX2 mitochondrial activation of spinal
cord neurons.
• What we do not know definitively: In whom are these changes
permanent?
– Does this potentially explain PART of the variance in
success/response we see clinically.
– Relevant considerations:
• Timeline “Mismatch” ?
• Biological readiness/capacity vs. Stage of Change?
• Co-occurring factors?
• Distress tolerance and modify relapse risk?

47. Mechanisms of neuroinflammatory
response to pain: Reactive Micgrogliosis

48. The challenge of treating opioid use
disorders
• 1.Neurochemical dysregulation
– Opioids induce profound changes.
– Opioids may induce midbrain cellular death.
• 2. It takes time for patients to get better
• 3. COR-12 care delivery model seeks to improve
outcomes by embracing tools that stabilize
neurochemistry and assist patients in early
recovery.

49. The Hazelden Betty Ford Response
• Alter the entire treatment of opioid dependence within
our system:
– A Comprehensive Opioid Response and the 12-Steps:
COR-12.
• We added groups, education and individual sessions for
opioid dependence
• We incorporated two evidence-based medications into
treatment protocols for opioid dependence: naltrexone
and buprenorphine/naloxone.
• We are studying the results
• Our goal will be discontinuation of medication as
patients become established in long-term recovery

50. Abstinence-Based Treatment: COR-12
Considering MAT
MAT- In general, may offer more patients the opportunity to positively
respond to treatment.
A large segment of the opioid dependent population was not
effectively being reached and treatment was not adequate.
This high risk population deserves the opportunity to engage in life
long recovery.
*MAT protocols will potentially blur the line of abstinence-based
programming. Our goal will always be discontinuation once long-
term recovery is established.

51. Borrowing from Twelve Steps and
Twelve Traditions
• Tradition 3
– “The only requirement for AA membership is a desire to stop
drinking”
– “Nothing seemed so fragile, so easily breakable as an AA
group……every AA group had membership rules.” (12x12,
p.139)
– “The answer now seen in Tradition Three, was simplicity
itself. At last experience taught us that to take away any
alcoholic’s full chance was sometimes to pronounce his
death sentence, and often to condemn him to endless
misery. Who dared to be judge, jury, and executioner of his
own sick brother?” (12x12, p.140)

52. COR-12: A Comprehensive Opioid
Response and the 12-Steps.

53. Phase I-Residential: COR-12
Treatment Planning
1. Chemical use disorder history and severity
-Prior treatment history
-Prior MAT history
2. Complicating medical or mental health factors
3. Environmental factors
4. History of “relapsing through” Suboxone or Vivitrol
-Must be seen in the context of prior treatment
-Structure? Monitoring? Patient Centered?

54. Phase II/Flexible Programming
• Options include:
– Intermediate care (halfway house)
– Day treatment (with or without structured
sober living)
– Intensive outpatient
– Extended outpatient
* All options require regular urine drug screens and
weekly participation in opioid support group

55. Phase III/Recovery Management
• Continued service options include:
– Sober living
– COR-12 weekly support group
– Weekly continuing care group
– Hazelden Connection
– MORE Recovery Coach
• My Ongoing Recovery Experience
• Distance recovery support with monitoring
– Additional Components:
• Longitudinal Medical with UDS monitoring
• Developing the discontinuation plan

56. Discontinuation Elements
• Factors continually assessed during phases II – III:
– Strength and stability of recovery program
– Collaboration between patient, physician & 3rd party
support
– Goal is for discontinuation of medication by 18
months.
– Considering Relapse:
• A percentage of patients relapse during phase II-III
• Reassessment  Appropriate level of care
– Opportunity to focus on Recovery support
– Consideration for a different MAT tool, or use an MAT tool if
previously a non-medication track patient.

57. COR-12 Research
• We are focused on patient engagement – for the
long term
• The clinical research supports the use of depo-
naltrexone, naltrexone, buprenorphine/naloxone.
• We borrowed heavily from models of intensive
Twelve Step practice (OA, SAA/SLAA) in which
total abstinence is not an option.
• We emphasize life long recovery.

58. COR-12
Patient Participation
Admissions to Center City Primary
One Year: January 2013– December 2013
18 Months: January 2013 – June 2014
One
Year
18
Months
2270 3385
Total number with opioid dependence 424 566
COR-12: No Medication 38 9%
52
9%
COR-12: Buprenorphine/Naloxone 30 7%
43
8%
COR-12: Extended Release Naltrexone
46
11%
70
12%

59. COR-12 Results 2013
• 20.64% of our opioid dependent patients who were
not in COR-12 discharged atypically.
• Only 11.11% of our opioid dependent patients
enrolled in COR-12 discharged atypically.
• COR-12 participants were 46% less likely to discharge
atypically.
• 6 former opioid dependent patients deceased in
2013; Zero were COR-12 participants.
59

60. Summary
• An opioid use crisis exists in the U.S. with a dramatic
increase in treatment admissions and overdose deaths.
• Opioids profoundly change CNS neurochemistry via neuro-
inflammatory cascades.
• Medication Assisted Treatment for opioid dependence is
effective, safe and can be aligned with abstinence-based,
12 Step programs to help more people engage in
successful, long-term recovery.
• We are ethically obliged to help this patient cohort through
combining scientifically supported treatments with time-
tested recovery fellowship.
60

61. Future Challenges
• 1. Integration of MAT services into primary
care delivery workforce.
– Barriers: Clinician Knowledge and Fear
Care silos
Delivery system lack of support
-Solutions: Education
Supportive Regulatory Posture
Incentivize Success

62. Future Opportunities
• 1. Medication Assisted Treatment for the
“therapeutically dependent” Pain Patient
population.
– 8-9 million Americans taking daily opioid therapy
– Minimal to no evidence that opioids are effective for
chronic nonmalignant pain.
– 30-40% meet criteria for a Substance Use Disorder
– What about the remaining 60%?
– Opioid rotation to buprenorphine?

63. Buprenorphine for Pain
Sublingual Buprenorphine Is Effective in the Treatment of Chronic Pain
Syndrome: Malinoff et. al.
Am. Journal of Therapeutics 12, 379-384 (2005)
Case series of 95 patients- chronic non-cancer pain, Long-term opioid
therapy
-Assessed Pain, Mood, Functional Capacity
-86% of patients had dramatic improvement in mood and function
-6% discontinued due to inadequate analgesia, nausea, headache
-Mean daily dose 8mg, duration of treatment was 8.8 months
-Well tolerated, no AE’s
The only published study of its kind.

64. Future Opportunities
• The most direct way to educate and integrate
MAT tools into the primary care workforce is
to assist primary care clinicians to treat their
existing patients with pain and therapeutic
dependency.
• Break the cycle of care termination.
• Empower ethical and compassionate care
within the medical home.
• Generate Medical Homes for Recovery.

65. QUESTIONS??????

66. Treatment Track:
Inpatient and Outpatient Treatments
for Pain and Addiction
Presenters:
• Amanda Wilson, MD, MS, Founder and CEO, CleanSlate
Addiction Treatment Centers
• Margaret Jarvis, MD, FASAM, Medical Director, Marworth
Alcohol and Chemical Dependency Treatment Center
• Andrew B. Mendenhall, MD, Outpatient Medical Director,
Hazelden Betty Ford Foundation
Moderator: Carla S. Saunders, NNP-BC, Advance Practice
Coordinator, Pediatrix Medical Group, and Neonatal Nurse
Practitioner, East Tennessee Children’s Hospital, and Member,
Rx Summit National Advisory Board