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.

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

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?

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?

Source: Schuman-Olivier 2013 Drug and Alcohol Dependence

Source: Schuman-Olivier 2013 Drug and Alcohol Dependence

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?

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