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

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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.

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(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

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