Tx 3 hill shuman_oliver

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 [email protected]

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


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


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


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


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


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:


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?


•  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

Health & Medicine

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