This document summarizes two presentations on treatment of opioid use disorders given at the National Prescription Drug Abuse Summit in 2014. The first presentation outlines the risks of current inpatient opioid detoxification methods and benefits of evidence-based alternatives. It also examines opportunities for stakeholders to impact opioid addiction education. The second presentation discusses innovations in buprenorphine treatment, including collaborative care models, group practice models, and strategies to address high-risk patients prescribed buprenorphine in office-based opioid treatment settings. Buprenorphine prescriber shortages, standards, retention challenges, and predictors of positive outcomes are also reviewed.

1. What’s Next for Treatment?
Kevin P. Hill, M.D., M.H.S.
Zev Schuman-Olivier, M.D.
Atlanta Marriott Marquis
Atlanta, Georgia
April 22, 2014

2. Disclosures
• Kevin P. Hill has no financial relationship
with a commercial entity producing health-
care related products and/or services.
• Zev Shuman-Olivier has no financial
relationship with a commercial entity
producing health-care related products
and/or services.

3. Learning Objectives
1. Outline the risks of the current inpatient opioid
detoxifications methods being used throughout the
country as well as the benefits of evidence-based
alternatives.
2. Examine opportunities for stakeholders in opioid
addiction to impact future education about opioid
addiction.
3. Identify an effective sublingual buprenorphine/suboxone
treatment regimen for subjects dependent on
prescription opioids.

4. Treatment of Opioid Use
Disorders:
Are We Making Progress
Like We Should Be?
Kevin P. Hill, M.D., M.H.S.
4/23/14, National Prescription Drug Abuse Summit
McLean Hospital Division of Alcohol and Drug Abuse Treatment
khill@mclean.harvard.edu
Twitter: @DrKevinHill
Supported by NIDA K99/R00 DA029115 (Kevin P. Hill, MD, MHS, PI) and the
Adam Corneel Young Investigator Fellowship from McLean Hospital to Dr. Hill.

5. Disclosure
I have no financial relationship with a
commercial entity producing health-care
related products and/or services.

6. Three Areas of Focus
• Clinical work: McLean Substance Abuse
consultation service, private practice.
• Clinical research: 3 clinical trials, co-
investigator on others (including CTN-30).
• Educational outreach: Science vs. public
perception, official community partner to
Boston Public Schools, book on marijuana
to be released in early 2015.

7. Prescription Opioid
Dependence: Prevalence
• In 2011, 4.5 million persons aged ≥12 years used
prescription opioids nonmedically in the past month
(1.7% of the population).
• 1.9 million were new users of Rx opioids.
• Among new users of illicit substances, this was the
2nd largest number of past-year initiates, after
marijuana, by about 700,000 people in 2011.
Substance Abuse and Mental Health Services Administration, 2012

8. Nonmedical use of psychotherapeutic
drugs, ≥12 years in the past month:
2002-2011
Substance Abuse and Mental Health Services Administration, 2012
+ Significant difference between this estimate and the 2011 estimate (p<.05)

9. From One Clinician-Researcher’s
Perspective
• Minimal change since 2007.
• Access to treatment remains an issue.
• While access to medications remains an
issue, attitudes toward medication may
have worsened.

10. A Sad Formula

11. Response and (Hopefully)
Results

12. But There Are Steps
We Can Take
The Epidemic is
Overwhelming

13. GAP BETWEEN
SCIENCE AND
PRACTICE

14. Successful outcome on BUP
at 3 months
A. 10%
B. 30%
C. 50%
D. 70%

15. Prescription Opioid Addiction Treatment
Study (POATS)
• Compared treatments for prescription opioid
dependence, using
• buprenorphine-naloxone (bup-nx) of varying durations
• counseling of varying intensities
• National Institute on Drug Abuse Clinical Trials Network
(NIDA CTN)
• Largest study ever conducted for prescription opioid
dependence
• 653 participants enrolled
• June 2006-July 2009
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246

16. POATS Study Questions
• Does adding individual drug counseling to
bup-nx+SMM improve outcome?
• May be a proxy for drug abuse treatment
program vs. office-based opioid treatment,
using bup-nx.
• What length of bup-nx is best for these
patients?
• 1 month?
• 3 months?
• Longer-term maintenance?

17. Study Design:

18. POATS
Main Trial Results

19. Successful outcome, Phase 1
(N=653)
SMM + ODC SMM p
6% 7% .36
Phase 1 successful outcome criteria:
• ≤4 days opioid use per month
• No positive urine screens for opioids on 2 consecutive
weeks
• No other formal substance abuse treatment
• No injection of opioids
• No more than 1 missing urine sample during the 12 weeks
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246

20. Successful outcome, Phase 2
(n=360)
Phase 2 successful outcome criteria:
Abstinent for ≥3 of final 4 weeks (including final week) of
bup-nx stabilization (urine-confirmed self-report)
SMM +
ODC
SMM p
Week 12
(end of
stabilization)
52% 47% .3
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246

21. Phase 2: Successful outcome at
end of taper & at follow-up
SMM
+
ODC
SMM Overall p
Week 16
(end of taper)
28% 24% 26% .4
Week 24
(8 wks post-
taper)
10% 7% 9% .2
Weiss RD et al. Arch Gen Psychiatry. 2011;68(12):1238-1246

22. Other studies should have a
greater influence, as well
• XR-NTX improved weeks of abstinence,
opioid-free days, craving scores, and
retention. (Krupitsky et al. 2011)
• Methadone’s efficacy for OUDs is well-
established.

23. And yet…

24. Gaps
• Brief detox with patients often discharged
with no medications to treat OUDs.
• Advocacy for residential treatment when
effective and cost-effective treatments
exist.
• Attitudes toward medication-assisted
treatment.

25. Anti-Medication Stance
• Patients and their families.
• Self-help groups.
• Residential treatment facilities.
• Health care providers(!).

26. Critical Period
• Trends are ominous.
• Work is being done on several levels.
• More education needed—there is
excellent research that few people know
about– and that must change.

28. Acknowledgments
• Roger Weiss
• Max Hurley-Welljams-Dorof
• Wendy Tartarini
• Joe Lewko
• National Rx Drug Abuse
Summit
• NIDA
• NARSAD
• McLean
• HMS
• Partners IRB
• FDA
• DEA

29. Questions?
Recruiting line:
617 855 3823

30. What’s Next for Treatment?
Innovations in buprenorphine treatment
National Rx Drug Abuse Summit-2014
Zev Schuman-Olivier, MD
Clinical Instructor in Psychiatry, Cambridge Health Alliance, Harvard Medical School
Adjunct Assistant Professor in Psychiatry, Geisel School of Medicine at Dartmouth
Investigator, Center for Technology and Behavioral Health at Dartmouth (NIDA P30)
Medical Director, WestBridge Community Services--Boston

31. 1) State
of
Buprenorphine
treatment
in
US
2) Buprenorphine
prescriber
shortage
3) Buprenorphine
prescribing
prac9ce
standards
4) Reten9on
in
buprenorphine
maintenance
treatment
5) What
predicts
posi9ve
outcomes
among
Rx
Opioid
abusers?
6) Innova9ve
models
for
expanding
access
and
providing
maintenance
7) Characterizing
the
high-­‐risk
OBOT
pa9ent
prescribed
buprenorphine
(HRPPB)
8) The
treatment
needs
for
HRPPB
9) Innova9ve
models
for
addressing
the
needs
of
HRPPB
10) Conclusions

32. • 9.3 million buprenorphine prescriptions dispensed in U.S. in 2012.1
• Growth in buprenorphine prescribing within treatment programs has been
mainly outside of OTPs2; and growth is also dramatic within medical offices.
1. IMS HealthTM National Prescription Audit Plus, 2. N-SSATS 2011
1. The State of Buprenorphine Prescribing in the U.S.
2012 N-SSATS
Non-OTP: 31,814
OTP: 7,409

33. N-SSATS: 14,311 facilities in 50 states (substance abuse treatment programs
and opioid treatment programs), 1,248,905 clients on 3/30/2012.
Response rate >93%
1. The State of Buprenorphine Prescribing in the U.S.

34. 2. Buprenorphine Prescriber Shortage in the U.S.

35. Numerous states
have developed their
own practice
standards as well.
3. Buprenorphine Practice Standards

36. • Determine
Opioid
Dependence
by
DSM
standards
• Assess
for
substance
abuse
treatment
history,
pregnancy,
&
levels
of
pain
• Evaluate
for
appropriateness
for
OBOT
treatment
and
h/o
illicit
B/N
use
• Readily
available
without
undue
delays
• Induc9on
(no
more
than
16mg
by
Day
2),
intensive
psychosocial
treatment
• Capacity
to
refer
for
appropriate
medical
and
mental
health
services
• Random
urinalysis
screening
(capacity
for
observed)
• Monitoring
treatment
progress
(illicit
drugs
and
alcohol)
• Ensuring
adherence
(buprenorphine)
• Call-­‐backs
for
pill-­‐counts,
short
scripts
(e.g.,
1
week)
un9l
stable
• Lockboxes,
especially
for
pa9ents
with
children
or
other
users
in
housing
• Single
pharmacy
and
use
of
prescrip9on
monitoring
program
checks
• Individually
tailored
treatment
to
pa9ent’s
needs
is
recommended
• Long-­‐term
approach,
possibly
with
mul9ple
a_empts
3. Buprenorphine Practice Standards

37. 4. Retention in buprenorphine treatment for
opioid dependence (Rx Opioid Abuse & Heroin)
(Table 2: Alford, et al 2011 Arch Int Med) (Fig. 1 Fiellin, et al 2008 AJA)
• Retention is important because OMT reduces overdose risk by 50%
(Clausen 2008 DAD).
• Rates of overdose deaths are up to 26.6 times greater in the month
after discontinuation of OMT (Davoli 2007 Addiction).

38. • Older age
• H/o major depression (other active SMI excluded from the trial)
• Having only used medication orally
• No history of prior opioid treatment
5. Additional predictors of positive outcomes among
Adult Rx Opioid Abusers in POATS trial
Dreifuss 2013 DAD

39. 6. Innovative Models for Expanding Access
• Many innovative models across the country, can’t mention them all
(acknowledge the northeast bias).
• Collaborative care: MA OBOT-B state expansion
• CHA OBOT with IOP with primary care provider network
• Addiction medicine team group model: CleanSlate

40. Collabora9ve
Care
(MA
OBOT-­‐B)
Adapted from Labelle, Sept. 2011
MA OBOT-B: 19 community health centers with 1 or more RN care managers
Goals: Treatment expansion and access to buprenorphine
100 patients per fulltime RNCM at each site
Expect 2-3 new patients a week per full time RNCM
CHA OBOT-B: 2-4 weeks IOP for stabilization, then weekly group

41. • Addiction medicine Group Model:
One Board Certified/Board Eligible Full time Addiction Physician
Team of full time Nurse Practitioners and/or Physician Assistants
Lab/Reception Staff
Part time physicians (Internal Med, Pediatrics, Psychiatry,
Family Medicine)
• Uses in-house risk assessment system for flexible levels of care
with up to twice-weekly visits.
• 3200 patients in Massachusetts among 9 Centers
http://www.cleanslatecenters.com/services

42. Types
of
Risk
in
OBOT
treatment:
Three
areas
leading
to
a_ri9on
or
administra9ve
discharge
from
OBOT:
1. Treatment
failure
risk:
ongoing
opioid
use,
frequent
relapse,
low
levels
of
treatment
reten9on
2. Safety
risk:
overdose
deaths,
accidental
injury,
accidental
inges9on
by
children
3. Diversion
risk:
illicit
trafficking,
sharing
with
others
7. The other 50%-- Characterizing the high-risk
OBOT patient prescribed buprenorphine

43. 1. Treatment
failure:
1. Emerging
adults
(18-­‐25
years
old)
7. Can we characterize who may be the
high-risk OBOT patients prescribed buprenorphine?

44. Admissions
repor9ng
primary
prescrip9on
opioid
abuse,
by
age:
1998
and
2008
Source:
SAMHSA. (9/23/2010). The TEDS Report: Characteristics of Substance
Abuse Treatment Admissions Reporting Primary Abuse of Prescription Pain
Relievers: 1998 and 2008. Rockville, MD: Office of Applied Studies. Page 2.

45. Source: Schuman-Olivier, et al Journal of Substance Abuse Treatment (under review)
Presented 2013 ASAM Med-Sci Mtg https://www.softconference.com/ASAM/sessionDetail.asp?SID=333068

48. 1. Treatment
failure:
1. Emerging
adults
(18-­‐25
years
old)
2. Psychiatric
co-­‐morbidity
7. Can we characterize who may be the
high-risk OBOT patients prescribed buprenorphine?

50. 1. Clinical:
1. Emerging
adults
(18-­‐25
years
old)
2. Psychiatric
co-­‐morbidity
3. Unstable
housing?
2. Safety:
1. Seda9ve,
benzodiazepine,
and/or
alcohol
dependence
7. Can we characterize who may be the
high-risk OBOT patients prescribed buprenorphine?

52. Source: Schuman-Olivier 2013 Drug and Alcohol Dependence

53. Source: Schuman-Olivier 2013 Drug and Alcohol Dependence

55. 1. Clinical:
1. Emerging
adults
(18-­‐25
years
old)
2. Psychiatric
co-­‐morbidity
3. Unstable
housing?
2. Safety:
1. Seda9ve,
benzodiazepine,
and/or
alcohol
dependence
2. Psychiatric
co-­‐morbidity
3. Diversion:
7. Can we characterize who may be the
high-risk OBOT patients prescribed buprenorphine?

57. Source: U.S. Drug Enforcement Administration, Office of Diversion Control. (2013). National Forensic
Laboratory Information System: Year 2012

58. Adapted from CESARFAX 2012

59. Lofwall 2012 DAD
Schuman-Olivier 2013 AJA

60. 1. Clinical:
1. Emerging
adults
(18-­‐25
years
old)
2. Psychiatric
co-­‐morbidity
3. Unstable
housing?
4. Neurologic
disorders
(Sever
brain
injury/impulsivity/cogni9ve
deficits)
2. Safety:
1. Seda9ve,
benzodiazepine,
and/or
alcohol
dependence
2. Psychiatric
co-­‐morbidity
3. Accidental
inges9on
by
young
children
3. Diversion:
1. Living
with
people
who
are
using
or
in
early
recovery
(sharing
study),
2. Low
levels
of
monitoring
3. Living
in
areas
with
low
levels
of
buprenorphine
access
4. Pa9ents
with
ongoing
opioid
use
5. High
doses
of
B/N
>24mg/day
6. Unwilling
to
engage
in
any
psychosocial
treatment?
7. Can we characterize who may be the
high-risk OBOT patients prescribed buprenorphine?

61. • Young
adults:
OBOT
a_ri9on
assoc.
with
low
adherence
(<5
out
of
7
days)
(Warden
2012
Add
Behav),
interven9ons
to
support
regular
adherence
• Psychiatric
co-­‐morbidity:
Needs
integrated
dual
disorder
treatment
(Drake)
• BZDS/ETOH:
Warnings
about
opera9ng
motor
vehicles;
BZD
Rx
reduc9on
vs.
elimina9on;
consider
transfer
to
injectable
naltrexone.
• Diversion
and
adherence:
Increase
access
to
high-­‐quality
care,
increase
prescriber
base
and
provide
support
to
providers
to
enable
more
frequent
contact.
Consider
care
manager
or
NPs
to
support
more
frequent
visits
and
diversion
monitoring.
Regular
prescrip9on
monitoring
program
checks.
• Rural
areas:
Increase
access
and
facilitate
monitoring
w/
limited
travel
needs
8. Addressing the needs of
High-Risk Patients Prescribed Buprenorphine

62. 9. Innovative Models for
High-Risk Patients Prescribed Buprenorphine
• Many innovative models across the country, can’t mention them all
(acknowledge the northeast bias).
• Vermont: Hub and Spoke
• Assertive Community Opioid Treatment with flexible model based on
overall risk calculator (WestBridge)

63. Vermont - Hub and Spoke

64. 7 more
items
(18 total)
http://www.uvm.edu/medicine/vchip/documents/VCHIP_2BUPRENORPHINE_GUIDELINES.pdf

65. Asser9ve
Community
Opioid
Treatment

66. Hub
Clinician
Pharmacist
Participant
Social
Support
Local Site
Clinician
Technician
MySafeRx
Pilot project supported
by NIDA Center for
Technology and
Behavioral Health at
Dartmouth
(PI: Schuman-Olivier)

67. 10.
Conclusions:
• Sublingual
buprenorphine/naloxone
is
an
effec9ve,
safe,
and
evidence-­‐
based
approach
to
maintenance
treatment
for
Rx
opioid
dependence
• Access
to
high-­‐quality
treatment
is
essen9al,
especially
to
prevent
demand
for
diverted
B/N
• Innova9ve
programs
can
help
expand
treatment
access
while
maintaining
prac9ce
standards
• Nearly
50%
of
pa9ents
may
require
some
addi9onal
support
beyond
current
prac9ce
standards
in
order
to
improve
treatment
outcomes,
maintain
safety,
and
prevent
diversion.
• While
MMTP
remains
the
current
standard,
innova9ve
solu9ons
may
soon
help
higher-­‐risk
pa9ents
remain
on
buprenorphine
by
providing
the
addi9onal
recovery
support
that
is
needed.

68. Acknowledgements
Collaborators/Mentors:
Mark
Albanese
Roger
Weiss
Lisa
Marsch
Robert
Drake
Mary
Brune_e
Howard
Shaffer
John
Renner
Hilary
Connery
Steve
Wya_
Bemna
Hoeppner
Eden
Evins
John
Kelly
Alan
Wartenberg
Research
Coordinator:
Jacob
Borodovsky
Funding:
Harvard
Med
Dupont-­‐Warren
NIDA
P30
CTBH
Pilot
grant
AAAP
Young
Inves9gator
Award