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Dr. Joshua Lee, M.D., M.Sc Associate Professor
Department of Population Health NYU School of Medicine
Tuesday, October 13, 2020
1:00 – 2:00 PM ET
Medications for OUD and Criminal Justice Systems and Settings
2
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3
Meet Our Speaker
Dr. Joshua Lee, MD, MSc
Associate Professor Department of Population Health, NYU
Associate Professor Department of Medicine, NYU
4
Disclosures
I have relevant financial relationships with ACCME-defined commercial
interests:
Grants:
• NIDA (U01s, R01, U10)
• Laura and John Arnold Foundation (x2)
• Indivior (ISS)
Study Drug: Alkermes (Vivitrol), Indivior (Suboxone)
Consulting: Epiodyne, Nirsum Labs, Drug Delivery Inc, Oar(Rx)
5
Learning Objectives
By the end of this presentation, attendees will be able to:
1. Analyze and interpret recent clinical trial data for OUD
medications in criminal justice system (CJS) settings.
2. Compare and contrast the practical and unique barriers
and differences between MOUDs in CJS.
3. List the advantages and disadvantages of daily versus
long-acting MOUD formulations in a case-based
framework.
6
(Pre-2020 Slide) MOUD + CJS: Things are
changing…fast?
• Opioid Epidemic driving reforms and $$$
• Wide recognition of MOUD + CJS importance
• Less so at DOJ, BOP, State DOCs, Jails, but growing…
• ADA : recent 2019 ACLU v Mass ruling in favor of agonist access
• Recent MD law requiring all MOUDs in CJS statewide (Gov.
Hogan is R)
7 7
• 28 (55%) state prisons
w some methadone
• Over 50% of only for
pregnant women or
for chronic pain.
• 7 states' prison
systems (14%) some
buprenorphine.
2009
8 8
Methadone:
requires CSAT OTP
400,000 US
Buprenorphine:
X-DEA MD/PA/NP
750,000-1,000,000 US
Naltrexone:
any prescriber
75,000-100,000 US
2018
C.Vestal, Pew Trust, Stateline, 2018
9
2020: COVID-19, Racial Justice, and continued
OUD-CJS Reforms
• Jails and Prisons are terrible environments for COVID-19 transmission
and treatment
− https://www.themarshallproject.org/2020/05/01/a-state-by-state-look-at-coronavirus-
in-prisons
• Added pressure to release low-risk detainees and inmates
− Early release and diversion: CA, NY, NJ. …. Non-COVID: Bail reform: NY, NJ
• Effects of COVID-19 on OUD and MOUDs likely varied
− Significant COVID-19 disruptions to methadone treatment systems and DOT
–Ex: NYC jails halted new patient methadone inductions March-June 2020
–US’ largest jail methadone program, ~500 per day
− In-clinic injections post-release were difficult as well: XR-Naltrexone, XR-
Buprenorphine
− NYC: most flexible MOUD has been buprenorphine-naloxone
10
SW, a 40 yo female in jail w OUD interested in
bup … 2019-2020
• Was using heroin prior to jail in Oct 2019, now on SL
buprenorphine-naloxone 2019
• Switched to XR-Buprenorphine (Sublocade) in a pilot study,
released Jan 2020, remained on XR-Bup w no heroin use
• After jail parole assigned her a shelter address, which she did
not like, found an apartment on her own, did not inform NYS
Parole appropriately and was re-incarcerated Feb-April 2020
• In NYC jail COVID19+, symptomatic, incarcerated throughout
illness
• In April community clinic was closed due to COVID, so switched
back to SL bup-nx through telehealth
• One self-reported heroin use occassion
• Back on XR-Bup, May-2020), then lost-to-follow-up
11
OUD+CJS Themes in this Case
• Transitions are often rough despite good OUD treatment
• Housing is a huge issue
• Parole conditions are nearly impossible – huge discretionary
power held by POs in terms of imposing violations
• COVID-19 easily and rapidly spread in corrections
• COVID-19 impacted usual OUD care at re-entry and in
community
SL Bup-Nx telehealth was vital
XR injections were clunky and generally require clinic visits
Some heroin use after jail while treated w MOUD is common
Despite steady outreach and universal MOUD availability,
lost-to-follow-up
12
COVID and OUD+CJS: 2020 Survey Research
• 10 of 16 CJS systems reported downsizing their OAT programs.
• 7 of 16 systems made changes to medication dispensation processes.
• 8 of 16 of systems report challenges implementing physical distancing (n = 8), and/or obtaining personal protective equipment (n = 8).
• 13 out of 16 systems some MOUD program participants were released early due to COVID-19 infection risk.
Bandara, S., Kennedy-Hendricks, A., Merritt, S., Barry, C. L., & Saloner, B. (2020). Early Effects of COVID-19 on Programs Providing Medications for Opioid Use Disorder in Jails and Prisons. Journal of addiction medicine, 14(5), e257–e260.
13 13
Does exposure to opioid substitution treatment in
prison reduce the risk of death after release? A national prospective observational study in England
Marsden, Addiction, 2017
In a 2017 English
national study, prison-
based opioid
substitution therapy was
associated with a 75%
reduction in all-cause
mortality and an 85%
reduction in fatal drug-
related poisoning in the
first month after release.
14
Systematic Review of MOUD + CJS: 2019
• Methadone RCTs involving 807 inmates (treatment n = 407, control n =
400)
• methadone provided during incarceration increased community
treatment engagement (n = 3 studies; OR = 8.69, 95% CI = 2.46;
30.75)
• reduced illicit opioid use (n = 4 studies; OR = 0.22, 95% CI = 0.15;
0.32) and injection drug use (n = 3 studies; OR = 0.26, 95% CI = 0.12;
0.56)
• did not reduce recidivism (n = 4 studies; OR = 0.93, 95% CI = 0.51;
1.68).
• Individual review of buprenorphine and naltrexone studies showed these
medications were either superior to methadone or to placebo, or were as
effective as methadone in reducing illicit opioid use post-release.
Moore, K. E., Roberts, W., Reid, H. H., Smith, K., Oberleitner, L., & McKee, S. A., 2019.
15
Rhode Island DOC:
MOUD at Release from Jail/Prison
•Green, JAMA Psychiatry, 2018:
Post-incarceration Fatal Overdoses After
Implementing Medications for Addiction
Treatment in a Statewide Correctional System (Research Letter)
Large and clinically meaningful reduction
in post-incarceration deaths from OD
among inmates released from
incarceration after implementation of a
comprehensive MAT program in a
statewide correctional facility
(a reduction contributing to overall
population-level declines in OD deaths)
16
Probability of attending a methadone
clinic in Rhode Island after release
(A) Intention-To-Treat: continuation vs.
forced withdrawal
(B) As-Treated: many ‘forced w/d’
individuals did access methadone
RichJ et al, The Lancet 2015
“Methadone continuation versus forced
withdrawal on incarceration in a combined
US prison and jail: a randomised, open-
label trial”
Methadone pre-arrest should be continued
during incarceration
17
The Effectiveness of In-Jail Methadone
Maintenance: since 1987 in NYC Jails
Magura, Stephen; Rosenblum, Andrew; Lewis, Carla; Joseph, Herman., Journal of Drug Issues;
Vol. 23, Iss. 1, (Winter 1993): 75.
18
• BUP-NX vs. Methadone at arrest
• N=116, 1:1 randomization
• Results:
-Higher % on BUP in-jail (82% vs. 75%)
• 10% vs. 2% D/C’d meds due to diversion
-Higher rate of post-release retention if BUP
• 48% vs. 23% (p<0.005)
• BUP appeared feasible and effective
19
NYC Jail-to-Community buprenorphine
No differences vs. non-jail
patients in community primary
care BUP
Same
retention
vs. non-jail
Same rates of urine results
and self-report of heroin use
20
Prison Buprenorphine-naloxone: RCT of in-
prison vs. post-release induction, 2014
Gordon, M. S., Kinlock, T. W., Schwartz, R. P., Fitzgerald, T. T., O'Grady, K. E., & Vocci, F. J. (2014). A
randomized controlled trial of prison-initiated buprenorphine: prison outcomes and community treatment
entry. Drug and alcohol dependence, 142, 33–40. https://doi.org/10.1016/j.drugalcdep.2014.05.011
• More community treatment if buprenorphine started pre-release:
47 vs. 33%
• No difference in urine or self-reported heroin or cocaine use
• No differences in re-arrest or re-incarceration
• No deaths, no fatal overdoses
Study design was a 2 (In-Prison Treatment Condition: Buprenorphine
Treatment Vs. Counseling Only) X 2 [Post-Release Service Setting
Condition: Opioid Treatment Program (OTP) Vs. Community Health
Center (CHC)] X 2 (Gender) factorial design. Maryland State Prisons.
21
XR-Naltrexone….marketed to and accepted by CJS
21
22
Less heroin relapse among parolees and
probationers not interested in agonist rx: XR-NTX + MM vs. Treatment as Usual, N=308 across 5 US Sites
LeeJD et al, 2016, NEJM
• Largest eval
of XR-NTX in
US at the time
• Clear relapse
prevention
effects if XR-
NTX
23
◆ Despite ‘catch up’ relapse post-XR-NTX, OD events favored XR-NTX at 18-months
◆ No signal of post-XR-NTX OD risk
XR-NTX vs. TAU in CJS-Involved Outpatients
Urines, 12 & 18 mos XR-
NTX TAU p
% opioid negative urine, 12
months 49% 45% ns
% opioid negative urine, 18
months 46% 43% ns
SAEs, 1-18 mos
Overdose, any 0 7 0.02
Overdose, fatal 0 3 0.25
All-case mortality 2 5 0.45
Long-Term Urine Positive Rates at 12- and 18-Months Catch up,
but OD Rates do not
Lee, JD 2016 NEJM (NIDA + in-kind drug [ALK])
24
XRNTX vs. TAU: OPIATE URINE TOXICOLOGY RESULTS PER VISIT
XRNTX-GROUP: OPIATE UTOX RESULTS ONLY TAU: OPIATE UTOX RESULTS ONLY
Pt ID Week 0/1 Week 2 Week 3 Week 4 Week 8 Pt ID Week 0/1 Week 2 Week 3 Week 4 Week 8
#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 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, 2015, Addiction)
Heroin users usually relapse after jail…
less if MAT
25
Pre-Screened in-jail
Randomized, N=119
XR-NTX
n=61
ETAU
n=58
Prefer detoxification, not seeking
methadone maintenance:
Randomized Trial Prefer methadone
maintenance:
Quasi-Experimental Trial
Methadone (MTP)
n=79
Consented
n=217
Active: 14
Complete: 35
Lost-to-FU: 6
Died: 3
Screen-Fails
n=19*
*7 of 19 (39%), excluded due
to illicit opioid use +UTOX
Active: 13
Complete: 34
Lost-to-FU: 11
Died: 3
Active: 34
Complete: 35
Lost-to-FU: 8
Died: 2
NY
C R
ike
rs Isla
nd
jails
B
elle
vu
e H
osp
ita
l Bigger longer RCT of XR-NTX vs.
TAU in NYC Jails, 2012-2019
26
NYC Jail RCT: Retention on XR-NTX, 0 – 24
weeks post-release
Injection (#)
Received
XR-N
Injection
Rate(%)
≥ 1 XR-N Injection 93%
≥ 2 XR-N Injections 52%
≥ 3 XR-N Injections 40%
≥ 4 XR-N Injections 34%
≥ 5 XR-N Injections 26%
All 6 XR-N Injections 28%
#2-6
In Community
#1
@
Jail
27
NYC Jail RCT: Urine Toxicology for XR-NTX vs.
ETAU, 6-months
# TxArm Wk02 Wk03 Wk05 Wk07 Wk09 Wk11 Wk13 Wk15 Wk17 Wk19 Wk21 Wk23 Wk25
007 ETAU
012 ETAU
013 ETAU
015 ETAU
024 ETAU
026 ETAU
030 ETAU
031 ETAU
039 ETAU
042 ETAU
044 ETAU
048 ETAU
050 ETAU
051 ETAU
055 ETAU
057 ETAU
060 ETAU
061 ETAU
067 ETAU
070 ETAU
072 ETAU
074 ETAU
087 ETAU
093 ETAU
096 ETAU
098 ETAU
101 ETAU
103 ETAU
104 ETAU
105 ETAU
106 ETAU
111 ETAU
116 ETAU
127 ETAU
129 ETAU
130 ETAU
132 ETAU
135 ETAU
141 ETAU
143 ETAU
147 ETAU
149 ETAU
152 ETAU
153 ETAU
161 ETAU
163 ETAU
167 ETAU
172 ETAU
182 ETAU
183 ETAU
191 ETAU
194 ETAU
197 ETAU
198 ETAU
203 ETAU
204 ETAU
211 ETAU
217 ETAU
# TxArm Wk02 Wk03 Wk05 Wk07 Wk09 Wk11 Wk13 Wk15 Wk17 Wk19 Wk21 Wk23 Wk25
011 XRNTX
014 XRNTX
018 XRNTX
021 XRNTX
023 XRNTX
025 XRNTX
027 XRNTX
028 XRNTX
034 XRNTX
035 XRNTX
045 XRNTX
047 XRNTX
049 XRNTX
052 XRNTX
053 XRNTX
058 XRNTX
059 XRNTX
062 XRNTX
065 XRNTX
066 XRNTX
068 XRNTX
069 XRNTX
073 XRNTX
079 XRNTX
081 XRNTX
082 XRNTX
090 XRNTX
092 XRNTX
094 XRNTX
095 XRNTX
100 XRNTX
102 XRNTX
107 XRNTX
108 XRNTX
110 XRNTX
112 XRNTX
118 XRNTX
122 XRNTX
125 XRNTX
126 XRNTX
131 XRNTX
134 XRNTX
138 XRNTX
142 XRNTX
145 XRNTX
146 XRNTX
148 XRNTX
154 XRNTX
155 XRNTX
159 XRNTX
165 XRNTX
171 XRNTX
174 XRNTX
175 XRNTX
181 XRNTX
184 XRNTX
190 XRNTX
195 XRNTX
201 XRNTX
XR-NTX (n=61)
ETAU (n=58)
% negative
urines
31% 247/792
23% 173/748
TAU XR-NTX
28
Newest FDA (2018) MOUD :
Buprenorphine extended-release (Sublocade)
Is BUP-XR an advance for Primary Care and CJS OUD treatments?
29
XR-Buprenorphine: CAM2038 vs. SL BUP-NX
Similar (non-inferior)
treatment retention
Superior weekly urine
abstinence rates
Braeburn’s weekly and monthly XR-B recently approved
in EU but only provisional FDA approval (2019) …
Industry Data; WalshS 2018 JAMA Internal Med
30
•Randomized, unblinded, pilot proof-of-
concept RCT evaluating 8 weeks of XR-B vs.
SL-B
•N=50 (target) adults with OUD already on SL-
B and with a pending release date
•Randomized 1:1 to XR-B (300mg/month) vs.
SL-B (8-24mg/day) treatment-as-usual
•Primary Outcome: in-jail
feasibility/acceptability
•Secondary Outcomes:
•treatment retention post-release
•adverse events (overdoses)
•qualitative interviews
XR Bup vs. SL Bup in Jail and at release:
Pilot RCT
31
Of 26 assigned to XR-B:
• 21 received 1st injection in jail (21/26, 81%)
• 5 refused or did not get 1st in. in-jail
• 3 of these 5 subsequently received XR-B in community (24/26, 92%)
Of 26 assigned to SL-B:
• All were released with 7-day supply of SL-B from jail (26/26, 100%)
Elimination of daily SLB medication dosing visits:
• 21/26 (81%) vs. SLB 0/26
Serious Adverse Events in Jail: 0 vs. 0
Diversion of SLB, Administrative Discharges: 0 vs. 0
XR Bup vs. SL Bup: in-jail feasibility
32
XR-B
(n=26)
# (%)
SL-B
(n=26)
# (%)
Retained in treatment
(Weeks 1-8)* 15 (58%) 10 (38%)
Days Covered by Active
XR-B inj. or SL-B Rx, mean
(SD)
44 (24.1) 18.1 (22.6)
Number of XR-B
participants who switched
to SL-B 7 (27%) N/A
Achieved 5/5 opioid/opiate
free urine toxicology 4 (15.3%) 3 (11.5%)
# Re-Arrested 2 (7.6%) 4 (15.3%)
SAEs** 2 0
More overall
treatment if XRB
but difference NS
More days on bup
if XRB, but 7 of 26
switched back to
SLB…similar urine
results
No overdoses in
either arm
XR-BUP at release from NYC jails:
treatment retention, heroin use,
jail re-incarceration, SAEs
33
CJS, MAT, Implementation: What do we do now?
Jail incarceration
1. Heroin User
jail
Begin detox care
Offer buprenorphine,
methadone, naltrexone
Refer back to community treatment
2. Methadone or
buprenorphine patient
jail
Continue
methadone/buprenorphine
Refer back to community treatment
No detox
34
CJS, MAT, Implementation: What do we do now?
Prison incarceration
Opioid dependent individual
Prison
Detox vs. Maintenance
Pre-release: Offer buprenorphine, methadone, naltrexone
Refer back to community treatment
35
CJS, MAT, Implementation:
Data is strong, so onto logistics and local factors
• All 3 medications now have solid 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? Meds are covered?
• How far away is the treatment provider?
• What are the patient’s preferences and motivations?
36
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
37
References
Green TC, Clarke J, Brinkley-Rubinstein L, Marshall BDL, Alexander-Scott N, Boss R, Rich JD.
Postincarceration Fatal Overdoses After Implementing Medications for Addiction Treatment in a Statewide
Correctional System. JAMA Psychiatry. 2018 Apr 1;75(4):405-407. doi: 10.1001/jamapsychiatry.2017.4614.
PMID: 29450443; PMCID: PMC5875331.
Farabee, D., Condon, T., Hallgren, K. A., & McCrady, B. (2020). A randomized comparison of extended-
release naltrexone with or without patient navigation vs enhanced treatment-as-usual for incarcerated adults
with opioid use disorder. Journal of substance abuse treatment, 117,
108076. https://doi.org/10.1016/j.jsat.2020.108076
Moore, K. E., Roberts, W., Reid, H. H., Smith, K., Oberleitner, L., & McKee, S. A. (2019). Effectiveness of
medication assisted treatment for opioid use in prison and jail settings: A meta-analysis and systematic
review. Journal of substance abuse treatment, 99, 32–43. https://doi.org/10.1016/j.jsat.2018.12.003
Schwartz RP, Kelly SM, Mitchell SG, O'Grady KE, Sharma A, Jaffe JH. Methadone treatment of arrestees: A
randomized clinical trial. Drug Alcohol Depend. 2020 Jan 1;206:107680. doi:
10.1016/j.drugalcdep.2019.107680. Epub 2019 Oct 28. PMID: 31753737; PMCID: PMC6980707.
Velasquez, M., Flannery, M., Badolato, R., Vittitow, A., McDonald, R. D., Tofighi, B., Garment, A. R., Giftos, J.,
& Lee, J. D. (2019). Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments
following release from jail. Addiction science & clinical practice, 14(1), 37. https://doi.org/10.1186/s13722-019-
0166-0
38
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PCSS Mentor Program is designed to offer general information to clinicians about
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