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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
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.
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.
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.
Disclosure
I have no financial relationship with a
commercial entity producing health-care
related products and/or services.
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.
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
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)
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.
A Sad Formula
Response and (Hopefully)
Results
But There Are Steps
We Can Take
The Epidemic is
Overwhelming
GAP BETWEEN
SCIENCE AND
PRACTICE
Successful outcome on BUP
at 3 months
A.  10%
B.  30%
C.  50%
D.  70%
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
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?
Study Design:
POATS
Main Trial Results
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
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
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
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.
And yet…
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.
Anti-Medication Stance
•  Patients and their families.
•  Self-help groups.
•  Residential treatment facilities.
•  Health care providers(!).
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.
Tx 3 hill shuman_oliver
Acknowledgments
•  Roger Weiss
•  Max Hurley-Welljams-Dorof
•  Wendy Tartarini
•  Joe Lewko
•  National Rx Drug Abuse
Summit
•  NIDA
•  NARSAD
•  McLean
•  HMS
•  Partners IRB
•  FDA
•  DEA
Questions?
Recruiting line:
617 855 3823
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
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	
  
•  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
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.
2. Buprenorphine Prescriber Shortage in the U.S.
Numerous states
have developed their
own practice
standards as well.
3. Buprenorphine Practice Standards
•  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
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).
•  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
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
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
•  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
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
1.  Treatment	
  failure:	
  	
  
1.  Emerging	
  adults	
  (18-­‐25	
  years	
  old)	
  
7. Can we characterize who may be the
high-risk OBOT patients prescribed buprenorphine?
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.	
  
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
Tx 3 hill shuman_oliver
Tx 3 hill shuman_oliver
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?
Tx 3 hill shuman_oliver
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?
Tx 3 hill shuman_oliver
Source: Schuman-Olivier 2013 Drug and Alcohol Dependence
Source: Schuman-Olivier 2013 Drug and Alcohol Dependence
Tx 3 hill shuman_oliver
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?
Tx 3 hill shuman_oliver
Source: U.S. Drug Enforcement Administration, Office of Diversion Control. (2013). National Forensic
Laboratory Information System: Year 2012
Adapted from CESARFAX 2012
Lofwall 2012 DAD
Schuman-Olivier 2013 AJA
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?
•  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
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)
Vermont - Hub and Spoke
7 more
items
(18 total)
http://www.uvm.edu/medicine/vchip/documents/VCHIP_2BUPRENORPHINE_GUIDELINES.pdf
Asser9ve	
  Community	
  Opioid	
  Treatment	
  
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)
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.	
  	
  
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	
  	
  

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Tx 3 hill shuman_oliver

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