Rx16 presummit mat-mon_200_1_bisaga_2walls_3coupland_4dupont_5garcia-rosales

Medication-Assisted Treatment
Presenters:
• Adam Bisaga, MD, Professor of Psychiatry, Columbia University Medical
Center
• Phillip Walls, RPh, Chief Clinical Officer, myMatrixx
• Michael Coupland, MA, RPsych, Network Medical Director, IMCS Group
• Robert L. DuPont, MD, Founding President, Institute for Behavior and
Health, Inc.
• Katherine Garcia-Rosales, BS, Research Assistant, Center for Substance
Abuse Research, University of Maryland College Park
Pre-Summit Workshop
Moderator: Kelly J. Clark, MD, MBA, FASAM, DFAPA, President-
elect, American Society of Addiction Medicine, and Member, Rx and
Heroin Summit National Advisory Board

Disclosures
• Michael Coupland, MA, RPsych; Katherine Garcia-Rosales, BS;
and Kelly J. Clark, MD, MBA, FASAM, DFAPA, have disclosed no
relevant, real, or apparent personal or professional financial
relationships with proprietary entities that produce
healthcare goods and services.
• Adam Bisaga, MD – Contracted Research: Alkermes
• Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center
• Phillip Walls, RPh – Employment and ownership interest:
Matrix HCS, Inc.

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:
– John J. Dreyzehner, MD, MPH, FACOEM – Ownership
interest: Starfish Health (spouse)
– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center

Learning Objectives
1. Explain the role of medications in assisting
recovery from opioid addiction.
2. Define keys to success when combining MAT
and behavioral therapy.
3. Examine the differences in heroin use among
patients receiving buprenorphine for opioid
use disorders.
4. Provide accurate and appropriate counsel as
part of the treatment team.

The role of medications in
assisting recovery from opioid
addiction
Adam Bisaga M.D.
Professor of Psychiatry at CUMC
Columbia University College of Physicians and Surgeons,
New York, NY

Outline
Medication-assisted treatment approach: historical
context
agonist-based treatment
antagonist-based treatment
Selecting the medication
Recovery and MAT
The role of PCSS in improving access to MAT

Medication-Assisted
Treatment Approach:
Historical Context

At beginning of 20th century, detoxification was considered adequate
for treatment of narcotic addiction
Addiction = physical dependence
But detoxification methods often more dangerous than withdrawal itself
E.g., beladona, cyanates, bromides, paraldehyde (promises of “magic” cures)
Since detox removed physical dependence it was supposedly curative
Patients who relapsed “chose” to do it - thus thought to possess an intractable
character/moral defect (a deficit in self-control)
Frequency of relapse led cities to set up narcotic clinics to legally
provide heroin or morphine to addicts
But short acting morphine required either multiple visits to clinic or take-home
Deemed failures, patients were going from clinic to clinic and diversion occurred
Opioid Addiction Cures: Early History (1900-20)

1914 Harrison Narcotic Act put severe restrictions on using opiates to
maintain active addicts, permitted only detoxification
Between 1919-1935, > 20,000 physicians were indicted and 10% went to prison;
First “Drug War”
By 1923, all clinics were closed
Care for addicts was transferred from physicians to law enforcement
Addiction medicine was decimated and disappeared for more than 50 years
Psychiatrists were promoting a character pathology view of addiction
to support institutionalization of addicts
The addict was not a normal person after all but a “deviant” (pleasure-seeker,
neurotic, psychopathic criminal, or inebriate who switched to heroin)
New approaches: psychoanalysis, ECT, brain surgery, aversion therapy, LSD
“Dark Age”: treatment was scarce and prison was frequent
Cures: Dark Age (1920-1950)

Post WWII epidemic and the Second “Drug War” (1950’s)
Heroin use emerge in the cities (NYC as a capital), crime on the rise
New treatments focused solely on detoxification methods, propagated by the
dominant treatment models (rehabs, NA, TC): abysmal failure
Narcotic Farm approach: >90% relapsed
The next wave of epidemic (60’s - baby boomers) was forming
Heroin overdose as leading cause of death in young adults in NYC
AMA/ABA recommended that clinics are set up to prescribe narcotics to
addicts
In NYC, Dr. Vincent Dole received funding to determine if a medical
intervention can be developed to treat heroin addiction
Cures: Drug-free treatment (1950-60)

In New York, Dole (with Nyswander and Kreek) began
inpatient experiments with methadone and developed a
metabolic theory of addiction
in contrast to psychological theories
Beginning shift from preoccupation with mechanics of
withdrawal to managing craving and drug-seeking
behaviors
Reclaiming of the medical model of the disorder
Methadone as a patient-centered medical treatment
It become possible to promote medicine and care instead of
law and control
The new era: medical model of opioid
dependence and its treatment (1964)
Dole & Nyswander

Agonist-Based
Treatment Approach

As originally proposed, methadone stimulates opioid receptors and
“normalizes” functioning of this system (opioid deficit?)
Not a heroin substitute
Prevents withdrawal symptoms
Relief of drug craving
Stabilizes affect without producing euphoria or impairment in functioning
Minimizes pathological brain responses to stress and drug cues
Blocks effects of other opioids (tolerance blockade)
By reducing drug-seeking, provides opportunity for the patient to begin
changing their behavior and address other problems
Treatment with methadone is a “corrective not a curative” intervention
therefore may need to be used long-term/ indefinitely
Treatment of Opioid Addiction with Methadone
μ OR Full
Agonist

Noticing a rapid beneficial effects in the first 6 patients D&N started
methadone maintenance treatment (MMT) clinic in 1964
it had 300 patients 1 year later
In 1966 the clinic model was adopted for expansion throughout the US
1972: 36,000 patients in NYC, 1976: 80,000 patients in the US
Medical approach was highly controversial, states looked for excuses to
shut clinics, doctors were threatened with arrests
Concerns about diversion led to imposing strict governmental controls in 1973
and 1974 (NATA) that remain to this day
Despite that, MMT expands in US and throughout most of the world
Currently there are 330,000 patients in the US and > 1 million worldwide
Methadone is on the WHO list of essential medications
Underutilized in the US (90% of counties have shortage of services)
It is “prohibited” in many parts of the world
Methadone Maintenance Clinics

Meta-analytical studies show methadone’s superiority over treatment
without agonists
Significantly better at treatment retention and reduction of heroin use
Higher doses are more effective than lower doses
Smaller effect on reduction of crime, mortality, and HIV risk behavior
Patients treated with methadone have a range of positive outcomes
Marked reductions of heroin and other drug use
Reduced morbidity & mortality
Reduced crime
Reduced risk of infections
Improved social & work functioning
However most data on effectiveness come from observational studies
Methadone Maintenance: Outcomes
(Mattick et al., 2009, et al., 2001; Faggiano et al., 2007)

Buprenorphine
Developed in 1960’s, used as a long-acting analgesic
partial agonist, ceiling on some effects (no possibility of overdose)
lower risk of tolerance and physical dependence
less withdrawal on discontinuation, low abuse potential
Buprenorphine was proposed as an alternative to methadone
first clinical trials in 80’s, offered to patients that were not interested/suitable
for methadone
Due to its pharmacological profile buprenorphine is safer in use
than methadone
less monitoring required
less oversight of treatment contributes to lower effectiveness (non-
adherence) and increased risks such as abuse and diversion
Partial
Agonistμ OR

Buprenorphine in France
1996: widespread introduction as a tablet in France with unrestricted
prescribing by GP’s
Dramatic drop in overdose deaths within few years
Most buprenorphine is prescribed by GP’s, most have 5 patients but 50% of
heroin users are treated (for free) because 20% of all physicians prescribe BUP
However, diversion became a public health issue in francophone countries
where it became a drug used intravenously (“poor‘s man heroin”)
(Auriacombe et al., 2001, 2004)
(Schwartz et al., 2013)

A combo product (buprenorphine/naloxone: 4/1 ratio) is introduced in the US
in 2003 with restricted prescribing (training, limited # of patients)
addition of naloxone decreases but not eliminates the risk of misuse
Currently there are 0.5-1 million patients treated (exposed) mostly outside of
the traditional addiction treatment programs
Less than 4% of US physicians are licensed to prescribe it and only half of
them are prescribing,
50% of prescribers treat 5 or fewer patients
Buprenorphine in the USA
SUBOXONE ZUBSOLV BUNAVAIL buprenorphine/
naloxone
buprenorphine

One year long study
Active group: 6 month of supervised buprenorphine, then take home dosing
Control group: 6-day detox followed by INTENSIVE psychosocial treatment
Very high drop-out rate and mortality in the detoxification-only group
20
15
10
5
0
0 50 100 200 250 350300150
Numberremainingintreatment
Time from randomization (days)
20%
dead
25% OPI + UTOX
75% dropped-out by 2 weeks
Kakko et al., 2003
Buprenorphine maintenance is superior to
intensive medication-free treatment

Prescription opioids abusers (n=653)
Adaptive design, patients who relapsed were re-treated in phase II)
Conclusions:
- Tapering from opioid maintenance after a period of successful improvement
leads to a nearly universal relapse
- No benefit of added drug counselling
Buprenorphine discontinuation leads to relapse
Model for limiting treatment duration
1 month
+ taper
3 months
maintenance
Abstinent
3 months
+ taper
2 mos f/u
Weiss et al., 2011

Among patients with an excellent 6 month response to treatment only
40% will remain in (free) treatment for 2 years
Poor treatment retention is a major barrier to success for young adults
Buprenorphine treatment in community settings
Matson et al., 2014
Long‐Term Treatment with Buprenorphine/Naloxone in Primary
Care: Results at 2–5 Years
Fiellin et al., 2008

Retention in treatment: long-term outcomes for MMT vs. BMT
Retention in treatment is superior in optimized (flex dose) MMT vs BMT
Patients started with BMT had lower treatment participation and higher
opioid use during the 5-yrs as compared to patients treated with MMT
At f/u close to 50% of patients were using opioids (less in MMT than BMT)
Days of opioid use per month
Hser et al., 2015
Patient retention in treatment

Effectiveness of methadone (MMT) vs. buprenorphine (BMT)
Retention in treatment (but not opioid use) is superior in optimized
MMT vs BMT (e.g., flexible dose)
MMT and BMT is similarly effective whether delivered in a primary
care or outpatient clinic setting as compared to the specialized
program
Adjunct psychosocial and contingency interventions (e.g. financial
incentives for opiate-free urines) enhance the effects of both MMT
and BMT
No significant differences in serious adverse effects for MMT
compared with BMT
some evidence suggests lower mortality with BMT vs. MMT
Overall greater benefits for MMT may be balanced by better safety of BMT
and preference of patients
(Mattick et al., 2009, et al., 2001; Connock et al., 2007)

Treatment with agonists: summary
Two major medications that dominate the field
Specialized treatment centers using methadone (MMT)
Outpatient-based treatment using buprenorphine (OBOT)
Strong and extensive evidence of effectiveness, conferring several
major benefits
BUT:
Risk of harm
Concerns about diversion
Fail to keep patients in treatment over the long haul
May limit patient’s involvement in recovery community
Other agonist options:
Buprenorphine XR (implant and injection)
SR morphine
Supervised heroin maintenance

Antagonist-Based
Treatment Approach

Opioid antagonist attach to the receptor and block other opioids from
exerting any effects
Naltrexone is a long-acting, high affinity, competitive opioid receptor
antagonist with an active metabolite
At sufficient blood levels naltrexone fully blocks all opioid effects
Naltrexone tablet was approved in 1984 for the blockade of
exogenously administered opioids
Naltrexone injection (extended release, Vivitrol) was approved in
2010 for prevention of relapse following opioid detoxification
Antagonist-based treatment

The concept of using opioid blockers after detoxification to treat opioid
addiction developed in parallel to methadone
First introduced in 1970s as oral preparations, with disappointing results
Difficulty with treatment initiation, low patient acceptability/adherence
Reviews concluded that there is no evidence that naltrexone is effective beyond
selected patient groups which discouraged its clinical use
1980s brought new developments:
Clonidine found effective in treating withdrawal
Development of naltrexone-assisted detoxification methods, an opportunity to
continue with naltrexone as a relapse prevention agent
Buprenorphine was introduced for detoxification
Work with naltrexone continued in 1990-2000s
Behavioral therapy was developed to improve adherence to oral naltrexone
Long-acting preparations of naltrexone become available to overcome problems with
non-adherence to oral preparations
Brief History of Naltrexone-based Treatment

Injections
1st gen: oil suspension
2nd gen: microspheres with
NTX in suspension
(Vivitrol) licensed in 2007
Improving Treatment Retention Using
Long-Acting Preparations
Implants
1st gen compressed NTX
c.1996, now licensed in
Russia
2nd gen: NTX mixed with
polymer matrix c. 2001

Behavioral component: blockade of the positive (reinforcing) effects
of heroin leads to gradual extinction of drug seeking
Patients who use while on naltrexone experience no effect and stop
using
Pharmacological component: naltrexone decreases reactivity to
drug-conditioned cues and decreases craving thereby minimizing
pathological responses contributing to relapse
Patients on naltrexone have no urges to use
Naltrexone Treatment: mechanism

Requirement of detoxification and a wait-period of 7-10 days after the
last dose of an opioid before treatment can be initiated
A major barrier for many patients who find difficult to tolerate withdrawal
Further complicated by the reduction of inpatient/residential treatment
programs
Difficulty with the induction due to the possibility of precipitated or
protracted withdrawal
Patients do not feel well at the beginning of the treatment
Requirement of close monitoring
Antagonist-based Treatment: limitations

Retention in treatment is used as a primary outcome of treatment with NTX
patients retained on NTX are mostly (90%) abstinent from opioids
treatment drop-out is usually associated with relapse
Treatment retention rate in groups treated with XR preparations is twice
that of the oral group, approximating 50-70% at 6 months
Efficacy of Naltrexone: oral vs. XR injection

Efficacy of XR-Naltrexone vs. placebo
Trials comparing injection of
naltrexone vs. placebo showed that
patients receiving active naltrexone
have
Better treatment retention
Less opioid use
Lower craving for opioids

Efficacy naltrexone: summary
Extended-release preparation(s) of naltrexone are more effective than
the oral preparation and should be the treatment of choice
Injection NXT can be supplemented with oral preparation if needed (e.g.
delay in receiving injection) to maintain blocking blood levels
XR preparation of naltrexone is a relatively new medication with limited
effectiveness research to date
There is less data available from controlled trials of XR-naltrexone as
compared to methadone or buprenorphine
No direct evidence yet available comparing efficacy of XR-naltrexone
vs. buprenorphine
Indirect comparisons show comparable treatment retention with lower
level of ongoing opioid use
No studies to suggest which patients will have a better response to
XR-naltrexone vs buprenorphine
Patient’s preference and clinical indications should determine
the choice of medication

Initiation of MAT:
Patient and Medication Selection

A range of treatment goals
Medically oriented treatment
Protection against risk of OD and death
Cessation of illicit opioid use (>90% negative toxicology)
Improvement in physical and psychological health
No dependence on other substances
No misuse/diversion of medications
Behaviorally oriented treatment
Teach skills necessary to cope with cravings and life stressors without drugs
The ultimate goal is to support long-term recovery to be maintained with or
without medication
sustained recovery
with abstinence
from all substances
minimization
of harms from
ongoing use
Opioid Dependence Treatment Goals

Barriers to implementing MAT
Lack of familiarity with the medications, limited training in addictions
Resistance from the treatment community to change the standard
approach (detox followed by “drug-free” program and AA/NA
In 12-step community, using medication to support abstinence is
considered unnecessary (even antithetical) for recovery
Major rehabilitation programs “do not support use of medications”
targeting addictions
Cultural sentiment that addicts are best served by joining AA/NA
However, standard approach is not only ineffective but dangerous
Detoxified patients have elevated risk of overdose and death
Detoxification not followed by the medication to prevent relapse
should be considered a malpractice (iatrogenic death)
maintaining an ineffective practice against the scientific evidence
would not be acceptable in any other branch of medicine

OTP
Addiction
Medicine/Psychiatry
Practice
Opioid User
Inpatient
Detoxification Unit
Methadone
Buprenorphine (OB)
Naltrexone
Residential
Programs
NaltrexoneBuprenorphine
Psychosocial
Only
Current treatment system is fragmented into “one size fits all” silos
Buprenorphine (DOT)

Comprehensive Outpatient Treatment Program (HUB)
Medication and Psychosocial Treatments
Opioid User
Methadone Buprenorphine (DOT)
Residential
Programs
NaltrexoneBuprenorphine (OB)
Addiction or Primary Care
Outpatient Practice
A comprehensive treatment program that offers multiple options “under
one roof” allowing a smooth transition from one option to another
according to patient’s needs

Opioid Dependent Patients
who are NOT Physically Dependent
YES
Relapse Prevention CBT
Support Groups
NALTREXONE XR
NO
Relapse Prevention CBT
Support Groups
NALTREXONE P.O. PRN
Returning to High Risk Environment
Increased stress
Persistent Craving

Educate About Treatment Options
Assess Patient’s Preference
Assess Prognostic Factors
Determine First-Line Treatment
Abstinence Induction
Using AGONIST
Detoxification and
Relapse Prevention
Using ANTAGONIST
NALTREXONE XR
STABILIZATION
Yes
No
METHADONE
STABILIZATION
BUPRENORPHINE
STABILIZATION
METHADONE
MAINTENANCE
NALTREXONE XR
MAINTENANCE
Yes
Response Response
BUPRENORPHINE
MAINTENANCE
No
Yes
Response
Patients who are actively using
No

Choosing methadone vs buprenorphine:
factors to consider
Interest in office vs. clinic-based treatment
Ability to adhere to treatment/program rules
Ability to follow safety procedures (e.g., monitor medication supply)
Medical and psychiatric stability
Use of other substances/severity of other SUDs
Other medications that may interfere with one of the agonists
What additional resources the patient need
Additional support, stability of housing, employment
History and response to previous treatments

AGONIST ANTAGONIST
Maintain physiological dependence/withdrawal on stopping + -
Reinforcing effects promoting medication adherence ++ -
Euphoric effects/abuse/diversion ++ -
Potential for tolerance development +/- -
Incompatible with ongoing illicit opioid use - +
Protection against overdose (in adherent patients) + +
May alter use of other drugs +/- ++
Duration of treatment Indefinite? ?
Cultural/ideological barriers to availability ++ -
Professional/public opposition ++ +
Choosing AGONIST vs. ANTAGONIST

Selection of candidates for naltrexone
Patients who are not interested or able to be on agonist maintenance
Patients who are detoxified and abstinent but at risk for relapse
Patients who failed prior treatment with agonist
Patients with less severe form of a disorder
Young adults often unwilling to commit to a long-term agonist
maintenance
Individuals who use opioids sporadically
Patients successful on agonist but who want to discontinue them
without risking relapse

Patients who may be better candidates for agonists
Patients with history of overdoses, particularly following detoxification
Patients with serious psychiatric or medical problems
Patients with limited social supports (unstable lives, homeless)
Patients who have been opiate-free but never felt “normal”
Patients with chronic pain requiring intermittent opioid treatment
Patients with severe GI disorders exacerbating during
withdrawal/abstinence
Patients with advanced liver disease

Early on methadone was thought to be a tool to assist in recovery
Emphasis of therapeutic alliance
Recovering staff were role models
High-dose and no limits on treatment duration
As the treatment expanded and regulations were imposed the dominant
approach shifted from recovery towards a “harm reduction”
Focus on reduction in social costs (crime, infections)
Decrease in ancillary services (for-profit programs)
Reduction of methadone dose and the duration of treatment
This turn away from the focus on recovery brought on another wave of
criticism and public/professional stigma
Can MAT be compatible with Recovery
(White and Mojer-Torres, 2010)

Reaffirmation of MMT effectiveness by professional, scientific, and
governmental organizations
Advocacy efforts of MMT patients
Accreditation of programs, focus on improving quality
Understanding opioid addiction as a chronic disorder
Emergence of recovery as an organizing paradigm
Efforts to extend acute care model to models of recovery management
(RM) & recovery-oriented systems of care (ROSC)
Revitalization of MMT (1990-present)

Betty Ford Institute definition of recovery
“Recovery from substance dependence is a voluntarily maintained
lifestyle characterized by sobriety, personal health, and citizenship”
Was expanded to include patients treated with medications
“…formerly opioid-dependent individuals who take naltrexone,
buprenorphine, or methadone as prescribed and are abstinent from
alcohol and all other nonprescribed drugs would meet this definition of
sobriety”
Recovery and medication status:
BFI Consensus Statement
(Betty Ford Institute 2007)

Low attractiveness to patients
Limited access/waiting lists
Sub-therapeutic dosing and dose manipulation
Premature administrative discharges, forced tapers
High dropout rates, low rates of sustained engagement
High-rates of post-discharge relapse and mortality
Low engagement in recovery community
Promoting role models/peer support
Combatting professional/social stigma attached to MAT
Engaging families in a sustained recovery-support process
Recovery Management approach aims to
address some of MAT limitations

Utilize Strength-Based Management: building meaningful and satisfying lives
Transition patients from professionally to a patient-directed recovery plan
Expands the care team to include a variety of professionals
Shift the treatment model from a directive expert model to a recovery partnership
model (consideration for patient’s autonomy)
Assure optimum duration of MAT (focus is on recovery not duration of medication tx)
Expand the services within the vibrant culture of recovery (“Recovery is Contagious”)
Extend delivery of recovery support services into the community (co-location)
Proactively link patients/families to recovery community support resources
Provide post-treatment monitoring, support and, early re-intervention if needed
Recovery checkups & re-engagement
Evaluate outcomes using (long-term) measures of recovery
Global health, quality of life, community contribution
Conduct anti-stigma campaigns
RM approach seeks to:

The role of PCSS
in improving access to MAT

The Providers’ Clinical Support System for Medication
Assisted Treatment is an initiative funded by SAMSHA in
response to the opioid overdose epidemic
PCSS-MAT is a national training and mentoring program
developed to educate healthcare professionals on the
use and availability of the latest pharmacotherapies
What is PCSS-MAT?

The overarching goal of PCSS-MAT is to make available
educational and training resources on the most effective
medication-assisted treatments
Buprenorphine
Naltrexone
Methadone
PCSS-MAT aims to reach providers who serve patients in
a variety of settings, including primary care, psychiatric
care, and pain management programs
PCSS-MAT Goal and Target Audience

PCSS-MAT Training Modalities
PCSS-MAT offers no-cost training activities with CME to health
professionals through the use of:
Buprenorphine Waiver Trainings
Naltrexone Trainings
Webinars (Live and Archived)
Online Modules
Case Vignettes
One-on-one and Small Group Discussions—clinical coaching
In addition, PCSS-MAT offers a comprehensive library of resources
Clinical Guidances and other educational tools
Community Resources
Listserv - Provides a “Mentor on Call” to answer questions about
content presented through PCSS-MAT
To join email: pcssmat@aaap.org

PCSS-MAT Mentoring Program
Designed to offer general information to clinicians about evidence-
based clinical practices in prescribing medications for opioid addiction
A national network of trained providers with expertise in medication-
assisted treatment, addictions and clinical education
Three-tiered mentoring approach allows every mentor/mentee
relationship to be unique and designed to the specific needs of both
parties
The mentoring program is available at no cost to providers

• 123 webinars and online modules with 22,399 training participants
• 212 Buprenorphine waiver trainings with 3,325 training participants
• 55 mentors and 200 mentees and growing
• 112 clinicians have participated in Small Group Discussions within
mentoring program (new initiative starting 2015)
PCSS-MAT Program Highlights

Funding for this initiative was made possible (in part) by Providers’ Clinical Support System for Medication Assisted Treatment (grant no.
5U79TI024697) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not
necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices,
or organizations imply endorsement by the U.S. Government.
PCSS-MAT is a collaborative effort led by American Academy of Addiction
Psychiatry in partnership with: American Osteopathic Academy of Addiction
Medicine, American Psychiatric Association, American Society of Addiction
Medicine and Association for Medical Education and Research in Substance
Abuse.
For more information visit: www.pcssmat.org
For questions email: pcssmat@aaap.org
Twitter: @PCSSProjects

Combination of Medication Assisted
Therapy and Behavioral Therapy:
Key to Success

Disclosure Statement
• Phil Walls, RPh – Employment and ownership
interest: Matrix HCS, Inc.
• Michael Coupland, CPsych, RPsych CRC, has disclosed
no relevant, real or apparent personal or professional
financial relationships with proprietary entities that
produce health care goods and services.

Learning Objectives
• Explain the role of medications in assisting
recovery from opioid addiction.
• Define keys to success when combining MAT
and behavioral therapy.
• Examine the differences in heroin use among
patients receiving buprenorphine for opioid
use disorders.
• Provide accurate and appropriate counsel as

Opioid Receptors
• Three types of opioid receptors:
– Mu receptors are responsible for interpretation of pain, analgesia,
respiratory depression, physical dependence, and euphoria
– Kappa receptors are responsible for modest analgesia, with little
respiratory depression and little physical dependence
– Delta receptors are not fully understood, however agonists show
poor analgesia
• Pharmacologic properties of opioids based on agonist or
antagonist effects at the Mu and Kappa receptor sites.

Agonist vs. Antagonist
• Pure agonist has affinity for binding at receptor sites and
activates receptors to produce effects
• Pure antagonist has affinity for binding and occupying
receptors but does not produce effect and therefore blocks
agonists from binding
• Mixed agonist-antagonist has affinity for binding at receptors
but produces an agonist effect at one receptor and an
antagonist effect at the other receptor

Opioid Classification
Drugs Mu Receptor Kappa Receptor
Pure Agonists Agonist Agonist
Mixed Agonist-
Antagonist
Antagonist Agonist
Pure Antagonist Antagonist Antagonist

Drug Classification
Agonists Mixed Agonist-
Antagonist
Antagonists
Morphine Pentazocine Naloxone
Heroin Nalbuphine Naltrexone
Hydromorphone Butorphanol Nalmephine
Fentanyl Buprenorphine
Codeine
Oxycodone
Methadone

Response to the Heroin Epidemic
The Centers for Disease Control and Prevention
recommend:
• Prevent people from starting heroin
• Reverse heroin overdose
• Reduce heroin addiction
With regard to the latter, the CDC recommends that
individuals addicted to heroin or prescription
opioids have access to medication assisted
treatment, which combines therapy with drugs like
methadone, buprenorphine or naltrexone with
counseling and behavioral therapy.

Consider the Danger of Misuse
One tragic report comes from Kentucky where the state has been
struggling to deal with first a prescription opioid epidemic and now
a heroin epidemic like so many other states. Passage of House Bill
1 in 2012 by the Kentucky legislature wa designed to control pill
mills and overprescribing of opioids, and achieved one goal:
prescriptions for these drugs declined.
However, the legislation did not put similar restrictions on
prescriptions for buprenorphine. When used properly these drugs
can help an addict quit using heroin without going through horrible
withdrawal - however, one addict was quoted as saying: “it was just
a great substitute for heroin. It was like doing the same thing,
really.” The initial impact of HB 1 was to cause the state’s pill mills
to turn into facilities that provided buprenorphine to addicts
without any of the oversight necessary to truly help the patient.

HB 1 Initially Led to a Surge in the
Abuse of Buprenorphine

In the workers’ compensation area, most patient on long
term opioids:
Do not have pre-existing traits or behaviors indicative
of addiction
Take their opioids as prescribed and do not have
aberrant drug screens, drug seeking behavior
Have physicians who are unwilling to make changes
to the prescribing patterns
Prescribing physicians are willing to use psychologist
support to assist patients to gain non pharmaceutical
pain management skills and to increase function

$ Chronic Pain
&
Disability
Behavior $
Biopsychosocial Model of Chronic Pain
Lifestyle: Exercise,
Smoking, Alcohol and
Drugs, Obesity / Diet
Work Attachment / Age
Depression / Anxiety
Personality Disorders
Hx of Childhood Abuse
Perceived Injustice
(retribution owed)
Fear Avoidant Behavior
(Guarding)
Catastrophic Thinking
Cortisol, substance p, serotonin, Norepinephrine,
vasodilatation, vasoconstriction

Dependence
&
‘Addiction’
Neurobehavioral Effects of Opioids
Increase Noradrenaline to
combat the depressive effects
Turn off innate
pleasure responses
Release Dopamine
(Pleasure)
***Tolerance Develops
Demotivation, compromised ability to regulate
unsafe behaviors
Paired association of Pleasure
with initiating reason for
opioids
Depress Breathing, Blood
Pressure, Alertness

Early Intervention Screening
…..to assess risk for chronic pain,
delayed recovery and opioid abuse

Early Identification of BioPsychoSocial Risk Factors
1. Psychosocial risk factors have been validated
a. Meta Analyses
b. Prospective studies
c. Control group studies
2. A Pain Screening Questionnaire has been validated
• Scores predict time loss / medical spend /function
3. Brief Cognitive Behavioral Therapy (CBT) interventions
can successfully intervene
• less time loss / medical spend /greater function

Webster LR, Webster RM. Pain Med. 2005;6(6):432-442.
Misuse 40%
Abuse: 20%
Total Pain
PopulationAddiction: 2% to 5%
Prevalence of Misuse, Abuse and
Addiction

COPE with Pain
Cognitive Behavioral Therapy (CBT)
 CBT is brief and time-limited.
 A sound therapeutic relationship is necessary for effective
therapy, but not the focus.
 CBT is a collaborative effort between therapist and client.
 CBT is based on stoic philosophy.
 CBT is structured and directive.
 CBT is based on an educational model.
 Homework is a central feature of CBT.

How to Treat Psychosocial Factors without ‘Buying’ an
unwarranted Psych Claim
The new ‘health and behavior assessment and
intervention’ codes ensure the claimant does not become
further ‘medicalized’
Psychiatric diagnosis and treatment codes are NOT used
unless there is already a mental health accepted diagnosis
CPT Code Descriptor
96150 Initial assessment to determine biological, psychological and social
factors affecting health and any treatment problems
96151 Reassessment to evaluate condition and determine need for further
treatment

Treatment
RTW Outcomes
Control Group Intervention Group
High Risk and
Very High Risk
High Risk Very High
Risk
Sample Size 36 62 109
% claims closed at 26 weeks
33% 76% 62%
% working at 26 weeks
17% 68% 39%
Avg claim duration at 26 weeks
24 weeks 18.7 weeks 20.2 weeks
Coupland, M., Margison, D. Early Intervention in
Psychosocial Risk Factors for Chronic Pain,
Musculoskeletal Disorders and Chronic Pain Conference,
Feb 2011, Los Angeles, CA

Treatment
High Risk vs. Low Risk Psychosocial
• 9% Fewer Pt. get Physical Therapy
• 10% Fewer Pt. get Imaging Studies
• 13% Fewer Pt. get Injections
• 6% Fewer Pt. get Surgeries
• 5% More Pt. get Vocational Rehabilitation
Outcomes @26 wks+
Coupland, M., Margison, D. Early Intervention in
Psychosocial Risk Factors for Chronic Pain,
Musculoskeletal Disorders and Chronic Pain Conference,
Feb 2011, Los Angeles, CA

Are Patients Receiving Buprenorphine
for Opioid Use Disorders Different in
Important Ways if they Used Heroin?
Robert L. DuPont, M.D., President
Institute for Behavior and Health, Inc.
www.ibhinc.org
Katherine Garcia-Rosales, B.S., Faculty Research Assistant
Center for Substance Abuse and Research
www.cesar.umd.edu

Disclosure
• Robert L. DuPont, M.D. wishes to disclose that he was
Vice President of Bensinger, DuPont & Associates
(1982-2015) and Chairman of its subsidiary
Prescription Drug Research Center (2003-2015).
Content will be presented in a fair and balanced
manner.
• Katherine Garcia-Rosales, B.S. has disclosed no
relevant, real or apparent personal or professional
financial relationships with proprietary entities that
produce health care goods and services.

Workshop Learning Objectives
1. Explain the role of medications in assisting
recovery from opioid addiction
2. Define keys to success when combining MAT
and behavioral therapy
3. Examine the differences associated with
heroin use by patients receiving
buprenorphine for opioid use disorders
4. Provide accurate and appropriate counsel as

The Clinical Challenge
• To distinguish between patients who use
opioids as prescribed and those who use them
nonmedically, often with other drugs, and/or
divert them to other drug users
• This is difficult because addicted patients and
those diverting drugs lie; physicians are not
good at recognizing dishonest patients

A Crucial Distinction:
Addiction vs. Physical Dependence
• Addiction has two key features:
– Continued use despite problems
– Dishonesty
• Addiction seldom involves only one drug whereas
physical dependence without addiction almost
always does involve only one drug
• The treatment of addiction is medically
challenging and lifelong

Physical Dependence
• The body’s adaptation to chronic use of a specific
drug or related class of drugs, e.g., opioid
dependence
• Withdrawal, when the drug is abruptly stopped,
is commonly associated with a reversal of the
effects of the drug and is often intensely
unpleasant
• Treatment for physical dependence is gradual
dose reduction and usually relatively brief

Today’s Presentation
• Explores the context of the heroin epidemic
• Focuses on one important new finding among
patients being treated for opioid dependence
• Those who have used heroin are different
from those who have not used this drug
• This difference matters for both prevention
and treatment

• Round one with heroin was from 1898 to 1914
– Heroin over-the-counter
– Rural, middle aged and mostly female
• Round two was from 1970 to 1978
– Both heroin use and sale linked to urban crime
– Mostly minority young men
• Round three is ongoing today
– In the context of massive use of prescription opioids
– Profound improvement in heroin distribution – easier
to get, more potent and far cheaper
Recurring Heroin Epidemics in the US
DuPont, 1971; DuPont & Greene, 1973; CDC 2015

Long-Term Changes in Heroin Use
• Demographics of heroin addiction/treatment have
changed over the last 50 years
– From an inner-city, minority criminal problem
– To a wider geographical distribution, involving primarily
white men and women in their 20s and 30s living in
suburban and rural areas
• Heroin use in the general population is rare compared
to many other drugs
• The number of new heroin users is increasing and
overdose deaths are rising dramatically
Cicero, et al., 2014; Center for Behavioral Health Statistics and Quality (CBHSQ) 2015

Rx Opioid-Heroin Use Connection
• During the 1960s heroin epidemic users often
chose heroin as their first drug
• Now most heroin users previously used
prescription opioids nonmedically before
starting heroin use
• Before today’s heroin users first used
prescription opioids, most used other drugs of
abuse, often starting in adolescence
Jones, 2013; Cicero, 2014

Today’s “Round Three” –
Initiation to Opioid Use
• In 2014, there were 1.4 million initiates to
nonmedical use of prescription pain relievers
– Lower than in recent years
– Average age of first use 21.2 years
• 212,000 initiates to heroin
– Significantly higher than in 2006 (90,000 initiates)
– Average age of first use 28 years
SAMHSA, 2014; CBHSQ, 2015

National Changes in Drug Overdose
Deaths per 100,000 2003-2014
Park & Bloch, 2016

Age-Adjusted Rates of Death Related to Rx Opioids
and Heroin Drug Poisoning in the US, 2000-2015
Data from CDC reported in Compton, Jones, & Baldwin, 2016

Nonmedical Use of Prescription Opioids and Heroin During the
Previous Year Among Persons 12 Years of Age or Older, 2002-2014
Data from CBHSQ reported in Compton, Jones, & Baldwin, 2016

Why the Dramatic Rise in Heroin Use
and Overdose Deaths NOW?
• Rise in prescription opioid use
• Dramatic improvements in the heroin supply
Compton, Jones, & Baldwin, 2016

It’s the Supply, Stupid!
• Heroin is delivered anonymously to your door
ordered by phone or online
• Low cost and high potency of heroin
• Implications for drug policy and the role of the
criminal justice system

New Research Questions
• How can physicians identify prescription
opioid patients at risk for transitioning to
heroin?
• How are patients with opioid use disorders
who use heroin different from those who do
not?

Persons Receiving Buprenorphine for
Outpatient Treatment of Opioid
Disorders: Are They Different If They
Also Used Heroin?
Garcia-Rosales, K., and Wish, E. D. Persons Receiving Buprenorphine for
Outpatient Treatment of Opioid Disorder: Are They Different if They Also
Used Heroin? 21st Annual University at Buffalo Undergraduate Research
Conference and 11th Annual Graduate School Opportunities Program,
July 23-25, 2015; Bioscience Day at University of Maryland, November
19, 2015

Methodology
Research Design:
• Secondary analysis of existing data from
157 patients who enrolled in an outpatient
treatment program in the Maryland-
Washington D.C. area who were being
prescribed buprenorphine
• Quasi-experimental design comparing
patients classified by self-reported heroin
and prescription opioid use

Instrument
Instrument:
Self-administered semi-structured questionnaire
developed by IBH:
• Demographics
• Self-reported lifetime use of: illegal drugs
(marijuana, PCP, heroin) and Rx opioids
(buprenorphine, methadone,
OxyContin/other Rx opioids)

• Majority of the sample were
males and almost half were
below age 30
• Half or more used
OxyContin/other Rx opioids
or buprenorphine without a
prescription
• About 1/4 (26%) had used
methadone without a
prescription

• Only 6% (9 persons)
reported using heroin only
• The analyses that follow
compare:
- 80 persons (51%) who
had used Rx opioids with
or without a prescription
and heroin
with
- 68 persons (43%) who
had used Rx opioids with
or without a prescription
only

• Users of Rx opioids + heroin:
- were younger than those who
had not used heroin
- began using Rx opioids before
heroin
- initiated Rx opioid use earlier
than the non-heroin users
• 2/3 (66%) of the Rx opioids
+ heroin users had used Rx
opioids for the first time
before age 20

• Users of Rx opioids + heroin were much more likely to have
used multiple drugs; 79% vs. 30% used three or more drugs
• Only 6% of the Rx opioids + heroin users used only one
additional drug

Limitations
• Sample likely not representative of the whole
population in treatment with buprenorphine
• Sole reliance on self-reported drug use
• Limited information collected about study
participants

Summary of Findings
• In this population of patients, there were two distinct
groups of patients who were identified based on past
history of heroin use
• Persons receiving buprenorphine for treatment of opioid
disorder who used Rx opioids + heroin were more likely to
misuse other drugs, to have begun use earlier, and to
engage in polydrug use
• Only a small minority (6%) who used Rx opioids + heroin
were not polydrug users and might be the new kind of
heroin users thought to be produced by the current
epidemic of prescription opioid misuse

Study Implications
• Physicians and health workers should capture an
extensive drug use history from patients being treated
for opioid use disorders
• Urine drug tests could be used to enhance self-
reported drug use history information
• Patients who have used heroin are likely to need
special interventions targeted at their polydrug use
• Effective treatment needs to fully address the patient’s
entire drug problem

Few Nonmedical Rx Opioids Users
Transition to Heroin
• Nationally, only a small subset of people who
started using prescription pain relievers non-
medically transitioned to heroin within 5 years
Initiated
Non-Medical
Use of Pain
Relievers
(10 million
over 5 years)
Initiated Heroin Use
(500,000 over 5 years)
20% of Recent Heroin Initiates Did
Not Previously Use Prescription Pain
Relievers
Only 3.6% of Initiates to Non-Medical
Use of Pain Relievers (360,000)
Transitioned to Heroin
80% of Recent Heroin Initiates
Previously Used Prescription Pain
Relievers
Muhuri, Gfroerer, & Davies, 2013

Individuals Who Use the Less Prevalent
Drugs are Most Likely to Use Many Drugs
Provided by the Center for Substance Abuse Research

Implications for Prevention and
Treatment
• Not every dependent prescription opioid user
is at risk to switch to heroin
• To prevent a switch to heroin, pain
management physicians need to focus on
patients who are long-time heavy users of
alcohol and other drugs of abuse

Additional Thoughts on
Opioid Addiction Treatment
• Medications only work while they are taken
• Opioid dependence is a life-long disease
• Most forms of treatment, including opioid
substitution therapy (OST), is short-term
• OST has no effect on the use alcohol or other
drugs
• What happens to opioid addicts when they
leave OST?

Thank you!
Questions and Comments

Institute for Behavior and Health, Inc.
• IBH is a 501(c)3 non-profit organization that
develops strategies to reduce drug use
• For more information and resources, visit the
IBH websites:
www.IBHinc.org
www.StopDruggedDriving.org
www.PreventTeenDrugUse.org
www.PreventionNotPunishment.org

Center for Substance Abuse Research
• The Center for Substance Abuse Research
(CESAR), at the University of Maryland at
College Park, is dedicated to addressing the
problems substance abuse creates for
individuals, families, and communities
• For more information and resources, visit the
CESAR websites:
www.cesar.umd.edu
www.ndews.umd.edu

References
• Centers for Disease Control and Prevention. (2015, July 7). Today’s heroin epidemic. Atlanta, GA: CDC. Available:
http://www.cdc.gov/vitalsigns/heroin/index.html
• Center for Behavioral Health Statistics and Quality. (2015). Behavioral health trends in the United States: Results
from the 2014 National Survey on Drug Use and Health (HHS Publication No. SMA 15-4927, NSDUH Series H-
50). Available: http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf
• Cicero, T. J., Ellis, M. S., Surratt, H. L., & Kurtz, S. P. (2014). The changing face of heroin use in the United States.
JAMA Psychiatry, 71(7), 821-826.
• Compton, W. M., Jones, C. M. & Baldwin, G. T. (2016). Relationship between nonmedical prescription-opioid use and
heroin use. New England Journal of Medicine, 374, 154-163.
• DuPont, R. L. (1971). Profile of a heroin-addiction epidemic. New England Journal of Medicine, 285, 320-324.
• DuPont, R. L. & Greene, M. H. (1973). The dynamics of a heroin addiction epidemic. Science, 181, 716-722.
• Jones, C. M. (2013). Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain
relievers—United States, 2002-2004 and 2008-2010. Drug and Alcohol Dependence, 132, 95-100.
• Muhuri, P. K., Gfroerer, J. C., & Davies, M. C. (2013). Associations of non-medical pain reliever use and initiation of
heroin use in the United States. CBHSQ Data Review. Rockville, MD: Substance Abuse and Mental Health Services
Administration.
• National Institute on Drug Abuse. (2015, December). Overdose death rates. Rockville, MD: Author. Available:
http://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
• Park, H. & Bloch, M. (2016, January 19). How the epidemic of drug overdose deaths ripples across America. New
York Times. Available: http://www.nytimes.com/interactive/2016/01/07/us/drug-overdose-deaths-in-the-us.html
• Substance Abuse and Mental Health Services Administration. (2014).Results from the 2013 National Survey on Drug
Use and Health: Summary of National Findings, NSDUH Series H-48, HHS Publication No. (SMA) 14-4863. Rockville,
MD: Substance Abuse and Mental Health Services Administration. Available:
http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.htm

Additional Reading
• Centers for Disease Control and Prevention. (2014, October 2). Heroin overdose deaths increased in many
states through 2012; still twice as many people died from prescription opioid overdoses. CDC Newsroom.
Atlanta, GA: CDC. Available: http://www.cdc.gov/media/releases/2014/p1002-heroin-overdose.html
• Centers for Disease Control and Prevention. (2015, July 7). Today’s heroin epidemic. CDC Vital Signs. Atlanta,
GA: CDC. Available: http://www.cdc.gov/vitalsigns/heroin/
• Centers for Disease Control and Prevention, Division of News & Electronic Media, Office of Communications.
(2013, February 20). Opioids drive continued increase in drug overdose deaths. Press Release. Atlanta, GA:
CDC. Available: http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html
• Centers for Disease Control and Prevention, National Center for Health Statistics. (2015, June 12). NCHS data
on drug poisoning facts. NCHS Fact Sheet. Atlanta, GA: CDC. Available:
http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.htm
• Chou, R., Turner, J. A., Devine, E. B., et al. (2015). The effectiveness and risks of long-term opioid therapy for
chronic pain: a systematic review for a National Institutes of Health Pathways workshop.Annals of Internal
Medicine. doi:10.7326/M14-2559 Available: http://annals.org/article.aspx?articleid=2089370
• Compton, W. M., Jones, C. M. & Baldwin, G. T. (2016). Relationship between nonmedical prescription-opioid
use and heroin use. New England Journal of Medicine, 374, 154-163.
• Frenk, S., Porter, K., Paulozzi, L. (2015) Prescription Opioid Analgesic Use Among Adults: United States 1999-
2012. NCHS Data Brief, No. 189. Available: http://www.cdc.gov/nchs/data/dataBriefs/db189.pdf
• Hedegaard, H., Chen, L., Warner, M. (2015) Drug-poisoning Deaths Involving Heroin: United States, 2000-
2013. NCHS Data Brief, No. 190. Available: http://www.cdc.gov/nchs/data/databriefs/db190.pdf

• Jones, C. M. (2012a). Prescription Drug Abuse and Overdose in the United States, presented at Third Party
Payer and PDMP Meeting, December 2012. Available:
http://www.pdmpexcellence.org/sites/all/pdfs/Jones.pdf
• Jones C. M. (2012b). Frequency of prescription pain reliever nonmedical use, 2002-2003 and 2009-2010.
Archives of Internal Medicine, 172(16), 1265-1267.
• National Institute on Drug Abuse. (2014, October). Heroin. DrugFacts. Rockville, MD: Author. Available:
http://www.drugabuse.gov/publications/drugfacts/heroin
• New York Times Editorial Board. (2015, March 2). Painkiller abuses and ignorance. New York Times, p. A18.
• Rudd, R. A., Paulozzi, L. J., Bauer, M. J., et al. (2014, October 3). Increase in heroin overdose deaths – 28
states, 2010 to 2012. Morbidity and Mortality Weekly Report, 63(39), 849-854.
• SAMHSA National survey of substance abuse treatment services. 2006. Found at:
http://wwwdasis.samhsa.gov/webt/state_data/US06.pdf.
• Sheir, R. (2014, November 21). Meet the man who tackled D.C.’s first heroin epidemic. WAMU 88.5 Metro
Connection. Available:
http://wamu.org/programs/metro_connection/14/11/21/meet_the_man_who_tackled_dcs_first_heroin_e
pidemic
• Volkow, N. (2014, May 14). America’s Addiction to Opioids: Heroin and Prescription Drug Abuse. Presented
to the Senate Caucus on International Narcotics Control. Available: http://www.drugabuse.gov/about-
nida/legislative-activities/testimony-to-congress/2014/americas-addiction-to-opioids-heroin-prescription-
drug-abuse
• Wood, G. (2014, March 19). Drug dealers aren’t to blame for the heroin boom. Doctors are. New Republic.
Available: http://www.newrepublic.com/article/116922/what-makes-heroin-crisis-different-doctor-
prescribed-pills

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