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Medication Assisted Treatment and
CJS Populations
Joshua D Lee, M.D. M.Sc.
New York University
[email protected]
@DrJoshuaDLee
Disclosures and Grant Support, LeeJD
• NIH (NIDA, NIAAA)
• NYU School of Medicine
• Alkermes
• Investigator-Initiated Trial (IIT)
• Study Drug Support
• Alkermes (Vivitrol)
• Reckitt Benkiser (Suboxone)
• No paid roles non-NYU
Outline
• Scope of the problem and ‘state of the state’
• Studies and data for CJS-opioid MAT treatment
•
MAT = Medication Assisted Treatment
• CJS-MAT and XR-NTX (Vivitrol) implementation
issues
• Summary
CJS Reform 2015: Heading in the right direction?
ACA + Parity
Pro-MAT Regs
(HHS, ONDCP)
MH-AddictionPrimary Care
Integration
Punishment
‘Right on
Crime’
Budget
Reform
The opioid epidemic and
Criminal Justice Systems (CJS)
Opioid misuse has increased in US, 1995-2015
• Prevalence of prescription opioid misuse
• ‘modernization’ of heroin markets
• Increase in opioid-related overdose deaths
• Now a public health and political crisis
CJS systems need to deal with:
•
•
•
•
Detox at arrest/incarceration
Treatment during incarceration
Treatment during community supervision
Recidivism, OD death, drop outs
Model Approaches vs. Usual Care
• Community care replaces correctional care
• ‘Warm’ CJS referrals to community programs
• NYC jail methadone program an example
• Prioritizing chronic care and panel management
• Medical homes, chronic disease management
• Not a model approach: no treatment while
incarcerated, resumption of chaos at release
Are opioids an increasing CJS issue?
Overall heroin and prescription opioid misuse has stayed flat
or declined, 2005-2015…Current impact on CJS is unclear:
•
US heroin seizures are not increasing (DEA.gov)
•
ADAM II arrestee urine data (NY, ATL, WDC, CHI, SAC, DEN)
shows overall flat or decreased heroin or oxycodone use across
these US cities since 2000 (whitehouse.gov)
•
US incarceration rates are flat or declining (doj.gov)
And yet…opioid-related overdose deaths are
increasing…we have a crisis or epidemic…regional growth
of heroin and opioid addiction
Opioids and CJS: Jails, Prisons, Community
Supervision
Jails
• Opportunity: detox and/or treatment
• Problem: most do not offer either of the two
Prisons
•
•
Opportunity: long-term or pre-release treatment
Problem: most do not offer any form of opioid-specific rx.
Drug Courts, Diversion, Parole, Probation
•
•
May better reflect community treatment standards
Problem: often discourage the use of opioid MAT (medications)
Why do CJS populations lack evidence-based
treatment?
CJS’ Mission
• Misuse of narcotics is illegal and drives punishment
• CJS facilities and authorities are not treatment providers
• Budgets prioritize safety, not health care
Stigma
•
•
Methadone and buprenorphine may have a bad reputation
Drug treatment is neglected in the community, anyway
Treatment preferences
•
Many patients and providers favor ‘drug-free’ recovery vs. the
use of medications (MAT)
Review: Why use Methadone, Buprenorphine, or Naltrexone vs.
‘drug-free’ counseling alone?
STUDY #2
WeissRD et al, Arch Gen Psyche, 2011
• Methadone
• Buprenorphine
• Buprenorphine/Naloxone
• Oral Naltrexone
• Extended-release Naltrexone
Detox
Relapse
In this outpatient study, relapse after brief detox w buprenorphine was 90%
Review: very high rates of relapse (50-90%) occurred after
typical detox episodes, despite on-going counseling
STUDY #2
KrupitskyE et al,
Lancet, 2011
Following inpatient detox, persons not on a medication were again using
opioids on average 65% of the time
CJS: Opioid users leaving jail
XRNTX vs. TAU: OPIATE URINE TOXICOLOGY RESULTS PER VISIT
XRNTX-GROUP: OPIATE UTOX RESULTS ONLY
Pt ID
Week 0/1
Week 2
Week 3
Week 4
TAU: OPIATE UTOX RESULTS ONLY
Week 8
Pt ID
Week 0/1
Week 2
Week 3
#008
N/A
#001
N/A
#009
N/A
#013
N/A
#010
N/A
#015
N/A
#017
N/A
#016
N/A
#019
N/A
#021
N/A
#020
N/A
#023
N/A
#024
N/A
#025
#026
#028
#027
#030
#029
#032
#031
#036
#033
#037
#034
#039
#035
#040
#041
#043
#044
#047
#045
#048
About to leave jail, urine is
‘clean’ = BLUE
Week 4
Week 8
After jail, using
heroin = RED
In a recent NYC jail study, 88% of persons not on a medication relapsed to heroin
use post-release (LeeJD, 2014, in review)
Relapse leads to very high rates of Overdose Death
following incarceration
SOURCE:
Binswanger et al, NEJM 2007;356:157-165
Addiction: ‘A Brain Disease’
Addiction Treatment: Healing ‘A Brain Disease’
Highest concentration
of Dopamine receptors
•Do we do something directly to the brain?
• Medications
•Do we isolate the patient away from drugs/alcohol?
• Residential treatment settings, incarceration
•Can the patient re-learn healthy, avoid unhealthy behaviors?
• Behavioral therapy
1. Scope of the problem
Opioid disorders in around 10-15% of US CJS
populations
Treatment outcomes are better with medications
•
lower rates of heroin and other drug use
Medication Assisted Treatment (MAT)
•
MAT: buprenorphine, methadone, XR-naltrexone
CJS outcomes of interest, will they improve w MAT?:
•
•
relapse, OD, crime
recidivism, costs?
2. Data: CJS and Opioid Treatment
What drives the best opioid outcomes?
Detox and counseling only? No
Medications? Correct answer
1) Methadone
2) Buprenorphine, Buprenorphine-naloxone
(Suboxone film, Zubsolv tablets)
3) Naltrexone (oral)
4) Extended-release Naltrexone (injection)
Reminder: What is the Difference between
Opioid Agonists & Antagonists?
Opioid
Effect
100
90
80
70
60
50
40
30
20
10
0
Methadone
Buprenorphine
Naltrexone
Dose of Opioid
Methadone prior to prison or jail release is effective
Figure 2 Probability of attending a
methadone clinic in (A) the intention-totreat and (B) the as-treated populations
Data are for 1 month follow-up after
particpants' release from incarceration.
Josiah D Rich , Michelle McKenzie , Sarah
Larney , John B Wong , Liem Tran ,
Jennifer Clarke , Amanda Noska , Man...
Methadone
continuation versus
forced withdrawal on
incarceration in a
combined US prison
and jail: a randomised,
open-label trial
The Lancet, 2015
Methadone outcomes across multiple studies
•
•
•
•
•
•
•
Less heroin use
Less IV use
Less HIV transmission
Less overdose death
Less criminal behavior
Saves taxpayers money
Longer lifespan
*Cochrane Reviews
Problems: Methadone Clinics and Stigma
• Federally-licensed clinics treating opioid dependence only
• limited locations
• limited number of treatment slots
• may only take insurance
• daily directly observed therapy (DOT)
• Patients have negative views (sedating, DOT, benzos, ‘rotting’)
• Providers have negative views of methadone patients and clinics
Reminder: Buprenorphine Office-based Treatment
• Medical office visit
• Retail pharmacy
• Chronic treatment
NYC Jail BUP. vs Methadone RCT,
2006-2008
• Methadone MTP standard of care
• N=116, 1:1 assignment at arrest
– Higher rate on BUP at release
– Higher rate of post-release retention if BUP
• 48% vs. 23% (p<0.005)
– BUP appeared a feasible and effective
• Methadone f/u rates were quite low
– Trial may have recruited more BUP-preferring
participants
*Magura, LeeJD, Drug and Alcohol Dependence, 2008
NYC Jail-to-Community buprenorphine
(Magura, 2008; LeeJD, 2009)
1. More randomized participants
continued bup-nx at jail re-entry vs.
methadone
• 48% vs. 23% (p<0.005)
2. Once in office-based bup-nx treatment,
no differences vs. non-jail patients
Same
retention
vs. non-jail
Same rates of urine results and
self-report of heroin use
Reminder: buprenorphine-naloxone (Suboxone) maintenance
produces better opioid treatment outcomes
vs. detox and counseling only
WeissRD et al, Arch Gen Psyche, 2011
Detox
Relapse
In this outpatient study, relapse after brief detox w buprenorphine was 90%
Buprenorphine Treatment and CJS
Many Pros!
•
The most common and available MAT medication in US
•
Any ‘X’ trained medical provider
•
General office-based or specialty treatment
•
Can be combined with all forms of counseling
•
Any jail or prison can prescribe and provide buprenorphine
A few Cons…
•
Relatively expensive out-of-pocket
•
Lack of uninsured and Medicaid prescribers
•
Controlled substance with diversion issues
Summary of CJS methadone and buprenorphine:
impact on mortality post‐release
• Ex-prisoners die
immediately (Week
1, Day 2) after
release
• Most deaths are drug
overdoses
Addiction
Volume 109, Issue 8, pages 1306-1317, 14 APR 2014 DOI: 10.1111/add.12536
http://onlinelibrary.wiley.com/doi/10.1111/add.12536/full#add12536-fig-0001
Summary of CJS methadone and buprenorphine:
impact on mortality post‐release
•
•
Pre- and post-release MAT lowered mortality (“Full OST” – Opioid Substitution Therapy)
Pre-release MAT only still lowered mortality by reducing overdose in Week 1
Addiction
Volume 109, Issue 8, pages 1306-1317, 14 APR 2014 DOI: 10.1111/add.12536
http://onlinelibrary.wiley.com/doi/10.1111/add.12536/full#add12536-fig-0002
Extended-Release Naltrexone (Vivitrol): the
opioid antagonist approach
• Monthly intramuscular injection
• Given by nurse, PA, MD,
pharmacist
• Non-narcotic, not a controlled
substance
• Must detox off opioids first!!
•
Jail, prison, detox, rehab, other
• Not for use if:
•
•
Pregnancy
Chronic pain requiring opioids
Study Design
1. Adults w Opioid Dependence (current or lifetime)
2. CJS + (recent parole, probation, jail/prison/arrest)
3. Not seeking agonist rx (methadone, buprenorphine)
4. Opioid negative (urine, self-report) at randomization
Randomization
XR-NTX
TAU
FU every 2 weeks
End of Treatment Phase, 6 months (week 27)
1° outcome: opioid relapse, rates of opioid misuse
Long-term FU @ 12, 18 months
RESULTS:
STUDY FLOW
437 Screened for eligibility
308 Randomized
129 Excluded
57
Screening incomplete
25
No opioid abstinence
19
Medical or psychiatric
3
Recent drug overdose
2
BMI>35
23
Other
153 Randomized to XR-NTX
146 Received XR-NTX as
randomized
7 refused XR-NTX
155 Randomized to TAU
155 Received TAU intervention
119 Completed 6-mos treatment
phase follow-up
7 Lost
8 Withdrew consent
1 Adverse events
0 Death
1 Moved residence
13 Incarcerated
4 Other
126 Completed 6-mos treatment
phase follow-up
4 Lost to follow-up
1 Withdrew consent
0 Adverse events
2 Death
5 Moved residence
15 Incarcerated
2 Other
153 included in primary analysis
155 included in primary analysis
Baseline characteristics
XR-NTX
84%, 44yo
37%
TAU
85%, 43yo
34%
36%
20%
40%
20%
Heroin use, every
Other opioid use, ever
Injection drug use, ever
Opioid use, current*
88.8%
50.7%
42.1%
20.4%
88.4%
47.7%
40.0%
16.8%
Cocaine use, current
19.7%
18.7%
Heavy drinking, current
11.8%
12.3%
Male, Age (mean)
Parole
Probation
No CJS supervision
*Current = last 30 days
Less heroin relapse among parolees and probationers:
XR-NTX vs. Treatment as Usual, N=308 across 5 US Sites
LeeJD et al, 2014, Poster
Primary Opioid Outcome:
No relapse, weeks abstinent, urines negative
100
90
80
p<0.001
p<0.001
p<0.001
70
XRNTX
TAU
60
50
40
30
20
10
0
% No relapse
% weeks
abstinent
% urines
negative
Long-term Follow-Up (18 Months)
Urines, 12 & 18 mos
XR-NTX
TAU
p
% opioid negative urine, 12
months
49%
45%
ns
% opioid negative urine, 18
months
46%
43%
ns
Overdose, any
0
7
0.02
Overdose, fatal
0
3
0.25
All-case mortality
2
5
0.45
SAEs, 1-18 mos
Opioid Use at 12 and 18 Months
Opioid urines: missing|positive
Self-report: any opioid use
XR-NTX prior to release: Less heroin use after jail
XRNTX vs. TAU: OPIATE URINE TOXICOLOGY RESULTS PER VISIT
XRNTX-GROUP: OPIATE UTOX RESULTS ONLY
Pt ID
Week 0/1
Week 2
Week 3
Week 4
TAU: OPIATE UTOX RESULTS ONLY
Week 8
Pt ID
Week 0/1
Week 2
Week 3
#008
N/A
#001
N/A
#009
N/A
#013
N/A
#010
N/A
#015
N/A
#017
N/A
#016
N/A
#019
N/A
#021
N/A
#020
N/A
#023
N/A
#024
N/A
#025
#026
#028
#027
#030
#029
#032
#031
#036
#033
#037
#034
#039
#035
#040
#041
#043
#044
#047
#045
#048
About to leave jail, urine is
‘clean’ = BLUE
Week 4
Week 8
After jail, using
heroin = RED
In a recent NYC jail study, 88% of persons not on a medication relapsed to heroin
use post-release (LeeJD, 2014, in review)
Stone County MO Drug Court Vivitrol Project
MAT Referral
Substance Type N=21
Demographic Profile
(1/1/2009 – 8/1/2013)
Male
14/21 (67%)
Female
7/21 (23%)
Alcohol Dependence
11/21 (52%)
Opiate Dependence
8/21 (38%)
Alcohol & Opiate
Dependence
2/21 (10%)
MAT – Extended-Release
Injectable Naltrexone
(Vivitrol) Outcomes
*Average
number of
months
Graduated
12/13 (92%)
6 months
Terminated
1/13 (8%)
1 month
Active
8/8 (100%)
Data were obtained from Clarity Recovery Center via NADCP Web Module (in dvlp)
*Average number of months that participant received MAT – Vivitrol injections
Other Drug Court XR-NTX publications
• 9% of US Drug Courts use Naltrexone (Oral of XR-) (Matuso
2013)
• Missouri / Michigan Drug Courts (Finigan 2011)
• N=32 Alcohol Dependent clients
• Improved attendance, fewer arrests, reduce alcohol use
• New Mexico (Lapham 2011)
• N=12 Alcohol Dependent DUI clients
• 3 mos. XR-NTX
• Fewer interlock ignition fails
Implementation: Data is strong, onto logistics
• All medications now have good evidence supporting
effectiveness
• Choice depends on patient, provider, environment
• Is the patient using and in community? Is detox already complete?
• Is there a provider accepting CJS referrals? Medicaid? Uninsured
patients?
• How far away is the treatment provider?
• Insurance status? Reimbursement in your state?
• What are the patient’s preferences?
Implementation: current treatment realities
Buprenorphine, Buprenorphine-Naloxone (Suboxone, Zubsolv)
• any provider with an ‘X’ DEA#...only 100 patients per MD
• office- or program-based prescribing
• the most common form of opioid medication treatment in US
Methadone
•
only available at an licensed Opioid Treatment Program (OTPs)
•
more stigma
XR-Naltrexone (Vivitrol)
•
only recently FDA approved
•
most expensive costs per month
•
antagonist requires patient to detox first…the ‘detox hurdle’
Implementation:
Which medications to use? For which patient?
So…
Is there a methadone provider in the county?
Is there a buprenorphine provider? Reimbursement?
Is there coverage/reimbursement for XR-NTX?
What is the patient motivated for?
…any type or choice of MAT will be effective vs. none
There are no well defined criteria dictating which med for which patient
beyond availability and patient preference
Implementation:
How to improve XR-NTX re-entry outcomes?
Patient education, patient preference
•
•
Does the patient really want this treatment?
Adherence boosters
•
•
negative CJS consequences?
•
•
parole violation, increased monitoring…
positive consequences?
•
money, prizes, privileges, etc?
•
social support?
•
counseling?
Implementation:
How to improve XR-NTX re-entry outcomes?
Patient matching
•
•
We don’t yet know which patients do best
Adherence boosters
•
•
CJS mandated treatment is an acceptable approach
•
Incentive Management works with other conditions
•
Case Management and Patient Navigation under study
•
Psychosocial treatment, meetings, are usual rec’s
XR-NTX (Vivitrol) for ALCOHOL USE DISORDERS
GarbuttJC, JAMA 2006
XR-NTX Alcohol Treatment In Bellevue Primary Care
• XR-NTX appears effective for Primary Care
medical management of alcohol
dependence
Treatment Retention
1
1
0.9
0.89
0.8
0.69
0.6
Drinking rates in treatment
0.56
0.5
30
0.4
0.3
25
0.2
0.1
20
0
Baseline
1st
Injection
2nd
Injection
3rd
Injection
#
Proportion
0.7
20
Drinking Days /
Month
15
# Drinks / Drinking
Day
12
10
56% of patient stayed in
treatment 90 days
Daily drinking reductions were robust
and seen within the first month
6
5
7
5
6
4
0
Baseline
Month 1
Month 2
Month 3
1st
2nd
3rd
Injecti
on
Injecti
on
Injecti
on
LeeJD, GrossmanE, GourevitchMN, et al, Journal of Substance Abuse Treatment, 2010
Prologue: MAT and CJS
Community bup-nx and methadone should be
continued during incarceration
•
•
Similar to HIV or MH meds
•
Use of MAT (bup-nx, methadone, XR-NTX) is a
long-term strategy (“maintenance”)
•
Any ‘dose’ of counseling goes with MAT
•
All MAT implies significant counseling from a
provider
Summary
• Scope of the problem and ‘state of the state’
•
Opioid disorders are poorly treated and CJS and health
outcomes are poor
• Studies and data for CJS-opioid MAT treatment
•
Good data supporting use of methadone,
buprenorphine, XR-NTX in CJS populations (jails,
prisons, parole, probation)
• CJS-MAT implementation issues
•
Availability varies. Patient enthusiasm and preference is
likely a key.