Pharmacotherapy for Opioid Dependence in Correctional Settings: Research Findings and Recommendations

Transcription

1 Pharmacotherapy for Opioid Dependence in Correctional Settings: Research Findings and Recommendations Robert P. Schwartz, M.D. Friends Research Institute

2 Overview of Presentation Background Research on uses of pharmacotherapy for opioid dependence during incarceration Summary & Recommendations

3 Correctional Institutions Jail Pre-trial detainees Short sentences (< 1 year) Prison Sentences > 1 year

4 Medications Opioid Agonist Treatment (OAT) 1) Methadone 2) Buprenorphine Opioid Antagonist Treatment to Prevent Relapse 3) Extended-release naltrexone (XR-NTX) Opioid Antagonist to Reverse Overdose 4) Naloxone

5 Illicit Opioid Use is a Problem Among Inmates High prevalence of a history of illicit opioid abuse among inmates (Perry et al., 2014): 20% in US 33% in UK 30% in France

6 Opioid Withdrawal Occurs among: Newly-arrested (out-of-treatment) Newly-arrested (in OAT) Prisoners actively using illicit opioids Untreated: Opioid Withdrawal Among Inmates Cruel Morbidity Creates an opioid market Reduces desire for OAT entry post-release (Mitchell et al. 2009)

7 Opioid Use Among Inmates Creates a market for drugs & corruption Overdose Hepatitis outbreaks (Taylor et al., 1995; Zamani et al., 2010)

8 Post-release Relapse Crime Re-incarceration HCV and HIV transmission Overdose death (Binswanger et al., 2007; Merral et al., 2010)

9 When Does Post-release OD Death Occur? Binswanger, et al., 2013, Annals of Internal Medicine

10 Pharmacotherapy for Opioid Dependent Inmates OAT in prison is considered a best practice (WHO, 2009) In the US: Methadone: not widely available (Nunn et al., 2009) Buprenorphine: used less frequently than methadone Extended-release Naltrexone: recently available Outside the US: Methadone: Australia, Canada, China, European Union, Iran, Malaysia and elsewhere (EMCDDA, 2009; Farnia et al, 2010) Buprenorphine: France & Australia (Marzo et al., 2009) Naltrexone Implant Trial: Norway (Lobmaier et al., 2010) Naloxone: UK N-Alive Trial: (Strang et al., 2013)

11 Barriers to Implementing Medications Lack of knowledge Negative attitudes (especially re: OAT) Punitive framework Institutional focus Concerns about diversion Funding silos Lack of regulatory requirements Complex oversight

12 Indications for Pharmacotherapy for Inmates 1. Provide continuity of care during incarceration For patients enrolled in community-based treatment 2. Initiate medication at detention For out-of-treatment individuals To reduce heroin use during incarceration To reduce relapse after release 3. Initiate medication prior to release For non-tolerant individuals with history of dependence To prevent relapse after release

13 Studies of Continuity of Care Longitudinal non-random assignment Magura et al., 1993; methadone in jail in New York City McMillan et al., 2008; methadone in jail in ABQ, New Mexico Random assignment Rich et al. 2015; methadone in jail in Rhode Island

14 Continuity of MTP in New York* 237 MTP patients were maintained on methadone in NY City jail Referred back to their MTP at release Most returned to MTP within 24 hours Treatment retention was modest at 5 months Men (n = 199) Women (n = 38) Returned to MTP 83% 79% Retained in Treatment: 1 month 88% 80% Retained in Treatment: 5 Months 57% 53% * Magura et al., Journal of Drug Issues, 1993

15 Continuity of MTP in NM: No Change in Recidivism* ABQ, NM jail Observational study of 589 inmates Outcome measure: time from release to rebooking Continuity of methadone was not associated with rebooking Limitations: Did not examine reasons for non-medication in jail nor rates of MTP reentry after release * McMillan, Lapham & Lackey, Addiction, 2008

16 Continued MTP v. Withdrawal in Jail: RCT* 2 group RCT compared forced withdrawal vs. continued methadone with 1 month post-release follow-up 223 adults enrolled in MTP at time of arrest Randomly assigned to continue MTP in jail or TAU TAU = slow methadone dose taper (3 mg/day) 45 of the 141 (32%) assigned to withdrawal were still on methadone at release Rich et al., 2015; Lancet

17 Baseline Characteristics Continued MTP (n = 114) Withdrawal (n = 109) Total Sample ( n = 223) Male (n/%) 87 (76%) 86 (79%) 173 (78%) Age (mean/sd) 33 (8.0) 36 (8.7) 34 (8.4) Days in Jail (mean/sd) Time in MTP (weeks) 56 (47) 56 (42) 56 (45)

18 Outcomes Continued MTP (n = 114) Withdrawal (n = 109) p Dosed on D/C Day 111 (97%) 45 (41%).0001 Opioid use (1 month) 9 (8%) 16 (18%).033 Entered MTP 106 (96%) 68 (78%).0001 Re-incarcerated 12 (11%) 8 (9%).67 ITT Continuing Methadone : HR 2.04 (95% CI, ) As treated: HR 6.61 (95% CI, )

19 Summary: Continuity of Care The RCT by Rich showed benefit of continuity of care Incarcerated individuals should have access to care equivalent to care available in the community Yet, 88% of US jails forced MTP patients to discontinue treatment while detained (Fiscella et al., 2004) More research on the value of continuity of care may not be warranted Research is needed on approaches to: Overcome implementation barriers Improve treatment retention post-release

20 Studies on Initiating Medication at Arrest There are 3 studies of OAT at arrest Longitudinal non-random assignment Magura et al., 1993; jail in New York City Random assignment Magura et al., 2009; Jail in New York City Schwartz et al., Recruiting: Jail in Baltimore, Maryland

21 Jail-Based MTP Evaluation: New York* Design: Longitudinal, non-random assignment evaluation of two cohorts. Inclusion Criteria: (1) Methadone Maintenance Cohort - Opioid dependent - Admitted to methadone treatment at Rikers Island - Misdemeanor charge or sentence < 1 year (2) Methadone Detoxification Cohort (Control) - Eligible for, but did not receive, maintenance because of: (a) low grade felony; (b) completed detox; or (c) no treatment slot * Magura et al., Journal of Drug Issues,1993

22 Methods Treatments: Methadone Maintenance - Methadone 30 mg daily - Limited counseling - Referred to select community-based MTPs Methadone Detoxification - Methadone x 7 days Assessments at Baseline and 6 month post release: - Demographics, drug use, treatment entry and retention

23 Participant Flow (Magura et al., 1993)

24 Follow-up Sample Demographics (N = 249) Variable Race/Ethnicity African American White/Other Hispanic N/(%) 156 (62.7%) 48 (39.6%) 147 (59.0%) Gender Male 139 (55.8%) Mean Age (Yrs) 33 Drug Injection (Y/N) 193 (77.5%)

25 Outcomes at 6.5 Month Follow-up (N = 249) Variable Maintenance (n = 195) Control (n = 54) Attended any community drug treatment program (n/%)* 166 (85%) 20 (37%) In treatment (n/%)** 53 (27.2%) 5 (9%) Any past month heroin Use (n/%) Any past month drug injection (n/%) 60 (31%) 12 (22%) 80 (41%) 22 (41%) * p <.001; ** p <.01

26 Conclusion Initiating Methadone Treatment in Jail was feasible Few attempts at diversion ( spit backs ) No conflicts among inmates Correction Officers reported patients calmer than others Most patients offered methadone, accepted it and stayed on it while incarcerated (95%) Significantly higher treatment entry and retention rates compared to controls Poor treatment retention even in methadone-treated group Limitation: High attrition rate and non-random assignment

27 Initiating Methadone v. Buprenorphine at Arrest Context: A NYC jail with a well established MTP that did not routinely offer buprenorphine treatment 133 adult male inmates sentenced from 10 to 90 days at Rikers Island started on at least one dose of methadone for opioid withdrawal Randomly assigned to Buprenorphine v. Methadone treatment Assessment at baseline & 3 month post-release follow-up Magura et al., Drug & Alcohol Dependence, 2009

28 Participant Flow

29 Baseline Characteristics ( N = 116) Buprenorphine (n=60) Methadone (n=56) Age (years) 38.4 (7.9) 40.7 (9.1) ns P African American (%) 25% 25% ns Hispanic 65% 62% ns Days of heroin use in 30 days prior to incarceration 28.0 (6.4) 28.6 (4.8) ns

30 Outcomes Buprenorphine (n=60) Discontinued for diverting medication 10% 1.8% Methadone (n=56) P Completed treatment in jail 82% 75% ns Attended Treatment at Release 48% 23% <.005 Re-incarcerated at 3 month f/u 40% 50% ns Days heroin use in 30 days prior to f/u 13.7 (14.3) 14.4 (13.4) ns

31 Conclusion Total sample reported a 50% reduction in days of heroin use from baseline to follow-up 3-month follow-up outcomes were not significantly different between medication groups Buprenorphine administration required more time than methadone administration (15 minutes vs. 3 minutes) and it was more expensive than methadone Diversion was more of a problem with buprenorphine treatment Relatively low treatment entry rates in both groups Limitation: No drug testing data

32 Study Locations 32 Friends PI Schwartz; NYU PI Lee; UCLA PI Farabee

33 Summary Of Initiating Medication Magura s research demonstrated feasibility of initiating methadone at the time of detention Post release entry and retention rates needed improvement Low rates likely hampered further improvements in drug use Patient Navigation may be a useful approach More research is need on approaches to increase: Treatment entry rates post-release Community treatment retention rates for this population

34 Continuity of Care & Initiating Medication: Studies with Mixed Samples Longitudinal non-random assignment Marzo et al., 2009; 47 remand prisons in France Favrod-Coune et al., 2013; remand prison in Geneva, Switzerland Random Assignment None

35 Studies on Initiating OAT to Reduce Heroin Use During Incarceration There are 2 such studies: Longitudinal non-random assignment Heimer et al., 2005; prison in Puerto Rico Random assignment Dolan et al., 2003; prison in New South Wales, Australia

36 MTP in Puerto Rican Prison* MTP Eligibility: Inmates with heroin dependence in prison and a sentence of < 2 years 20 started on MTP in prison and compared to 40 randomly selected non-mtp patient prisoners Prison MTP (n=20) Non MTP (n=40) Subset of Heroin using non MTP (23) Heroin use in prison, baseline 20 (100%) 23 (57.5%) 23 (100%) Daily use while in prison, baseline 18 (90%) 6 (15%) 26.1% Heroin use in past 30 days, F/U 1/18 (5.6%) 15 (37.5%) 65.2% Opioid positive test, F/U 1 (5%) 9 (22.5%) 39.1% Methadone positive test, F/U 20 (100%) 0 0% * Heimer et al., Drug and Alcohol Dependence, 2005

37 Conclusion Many prisoners were using heroin in this prison in Puerto Rico Methadone suppressed heroin use during prison sojourn Limitation: Small sample size No random assignment No post-release F/U data

38 Methadone Treatment In Australian Prison: RCT* Context: Prison MTP with a 6 month waiting list Participants: 382 adults on prison MTP wait list Conditions: Randomly assigned to: 1) Wait list control for 4 months 2) Begin methadone treatment Follow-up: 4 months * Dolan et al., Drug and Alcohol Dependence, 2003

39 Heroin Use In Prison (Self-report or Opioid Positive Hair Test)

40 % Syringe Sharing (%)

41 Conclusions This study showed clear benefits to providing methadone maintenance during incarceration to reduce in prison heroin use and syringe sharing. It could be employed to reduce the likelihood of HIV or hepatitis outbreaks in prison.

42 Studies of OAT as Relapse Prevention There are 7 studies of OAT for non-opioid tolerant prisoners: Longitudinal non-random assignment Albizu-Garcia, 2007, Prison, Puerto Rico [buprenorphine] Zaller et al., 2013; Prison, Rhode Island [buprenorphine] Random assignment Dole et al., 1969 Rikers Island Jail, NY [methadone] Kinlock et al., Baltimore Prison, MD [methadone] McKenzie et al., Rhode Island Prison [methadone] Gordon et al, Baltimore Prison [buprenorphine] Lee et al., New York Jail (extended release naltrexone]

43 Buprenorphine Treatment in Prison: In Puerto Rico* High rates of heroin use in prison Open-label, pre- post design feasibility study 45 pre-release male inmates Buprenorphine provided by prison health staff Over 80% were opiate tolerant at induction Non-tolerant participants started at low dose (2/.5 mg.) 3 dropped out (2 nausea and 1 transfer to another prison) * Albizu-Garcia et al., Journal of Addiction Medicine, 2007

44 Outcomes High rate post-release treatment entry at physician officebased practice 78% of participants were in treatment at 1 month postrelease Low rate of opioid use post-release 25% opioid positive drug tests Limitation: Small pilot study without control group

45 Buprenorphine Treatment in Prison: In Rhode Island* Two-group pilot feasibility study (N = 44) Open-label, pre- post design feasibility study First cohort started buprenorphine in the community (n = 32) Second cohort started buprenorphine in prison (n = 12) 6 month F/U interview for self-reported drug use and treatment participation * Zaller, McKenzie, Friedmann et al., Journal of Substance Abuse Treatment, 2013

46 Outcomes: Post-release & 6 Month F/U Starting buprenorphine in prison was feasible Bup after release (n=32) Bup in prison (n=11) p Attended first outpatient visit 25 (78%) 11 (92%) ns In treatment at 6 month F/U 11 (34%) 10 (91%).005 Non fatal OD 3 (12%) 0 ns Heroin Use, past 30 days at F/U 6 (24%) 0 ns Arrested 6 (17%) 0 ns Limitation: Small pilot study, no drug testing

47 First Methadone Study in NYC Jail* This landmark study sought to determine: Inmates interest in methadone treatment prior to release The effectiveness of initiating methadone treatment prior to release. Inclusion criteria: Adult male inmate at Rikers Island; willing to apply for methadone treatment; history of at least 5 years of heroin addiction and 5 prior convictions. Exclusion criterion: Under community supervision after release. * Dole et al., NEJM, 1969

48 Methods 12 randomly selected adult male inmates w/history of opioid dependence from among MTP applicants were started on methadone about 10 days prior to release. Patients were not opioid tolerant at the time of dose induction Methadone started at low dose: 10 mg po QD Slowly increased (over 10 days) to about 35 mg prior to release Comparison group created of 16 randomly selected MTP applicants at Rikers Island Jail.

49 Outcomes Large number of program applicants entered waiting lists Follow-up interviews conducted at 7 10 months after release N Lost Jail Readdicted Heroin Use without re-addiction No Use Methadone (25%) 0 10 (83%) 2 (17%) Control 16 1 (6%) 15 (94%) 15 (94%) 0 0

50 Conclusions Initiating methadone prior to release for a sample of previously detoxified individuals was desired & feasible Methadone as relapse prevention Early demonstration of effectiveness Limitations: Small sample No drug testing

51 Methadone Treatment for Prisoners: RCT* 211 adult pre-release prisoners in Baltimore were randomly assigned to: 1) Counseling in prison + passive referral 2) Counseling in prison + Methadone Post-release 3) Counseling in prison + Methadone Post-release F/U interviews at 1, 3, 6, and 12 months post-release * Kinlock et al., Drug and Alcohol Dependence, 2007

52 Treatment One individual counseling session and 12 weekly group sessions Methadone started low (5 mg daily x 7 days) Methadone increase by 5 mg/week to target of 60 mg

53

54 Baseline Characteristics (N = 204) Categorical Variables Counseling Only Counseling + Transfer (n = 69) Counseling+Methadone (n = 71) n (%) (n = 64) African American 41 (64.1) 51 (73.9) 50 (70.4) Caucasian 21 (32.8) 13 (18.8) 15 (21.1) Other 2 (3.1) 5 (7.2) 6 (8.5) Prior methadone treatment 15 (23.4) 17 (24.6) 15 (21.1) Continuous Variables Mean (SD) Age 40.7 (7.5) 40.3 (6.7) 39.9 (7.0) Heroin use days 27.1 (7.8) 27.8 (6.1) 26.7 (8.9)

55 Outcomes Entered MTP (within 30 days) Counseling Only (n = 64) Counseling + Transfer (n = 69) Counseling + Methadone (n = 71) 8.2% 48.4% 69.6%.0001 p Days in MTP (past year) Opioid positive (12 month F/U)* Cocaine positive (12 month F/U)* < % 48.7% 25% < % 66.6% 43.2% <.05 Re-arrest (past year) 50.8% 59.1% 52.9% ns Overdose deaths * Limited urine samples available CO (32); C+T (39), C + M (44)

56 Conclusion Treatment entry and retention rates superior for group starting medication in prison Second best approach would be to start just after release Care must be taken with dosing of non-tolerant individuals Positive drug tests were lower for group starting methadone in prison Limitation: Missing samples No difference in re-arrest Starting methadone in prison prior to release seemed promising

57 Methadone Prior v. Post-release: RCT 90 opioid non-tolerant adult inmates with history of opioid dependence in Rhode Island were randomly assigned to: 1) methadone prior to release with post-release MTP subsidy 2) Methadone after release with post-release MTP subsidy 3) Methadone after release without post-release MTP subsidy Methadone started LOW (5 mg) and increased SLOW (2 mg/day) 6-month follow-up interviews McKenzie et al, Substance Abuse, 2012

58 Methods As treated analysis 4 participants assigned to pre-release dosing did not start for logistical reasons and were analyzed with post-release data During the study, a new federal grant provided MTP subsidy to all participants and hence those participants who were randomly assigned to non-subsidy were analyzed with group receiving subsidy Average daily methadone was 33 mg at release

59 Demographics (N = 90) Variable Race/Ethnicity White Hispanic N/(%) 45 (72.5%) 13 (21.0%) Gender Male 44 (71%) Mean Age (Yrs) 40.7 Drug Injection (Y/N) 40 (64.5%)

60 Outcomes at 6 Month Follow-up (N = 90) Variable Attended MTP within 30 days (n/%)* In treatment at F/U (n/%)** Heroin use past 30 days (n/%) Re-arrest past 6 months (n/%) MTP in prison with subsidy (n =21) MTP after prison with subsidy (n =32) MTP after prison no subsidy (n = 9) p 18 (85.7%) 13 (40.6%) 2 (22.2%) < (66.7%) 15 (46.9%) 4 (44.4%) ns 3 (14.4%) 18 (56.3%) 4 (44.4%) (33.3%) 9 (28.1%) 2 (22.2%) ns

61 Conclusion Group starting methadone in prison had higher rate of postrelease treatment entry and lower rates of opioid positive tests (similar to Kinlock and co-workers findings) Treatment retention was not significantly different This area needs more research on approaches to improve retention (as in the case of continuity of care) Arrest rates at follow-up not significantly different Arrest may be more of a function of policing and poverty

62 Buprenorphine in Corrections Buprenorphine as compared to methadone may have: Less stigma Fewer regulatory barriers in US Better safety profile

63 Pre-release Buprenorphine Treatment for Prisoners: RCT* 211 male and female pre-release inmates in Baltimore with histories of heroin dependence prior to incarceration were randomly assigned to: 1. Counseling + Buprenorphine in prison with referral to continue buprenorphine in the community 2. Counseling Only in Prison with referral to buprenorphine in the community *Gordon, Kinlock, Schwartz et al., Drug & Alcohol Dependence, 2014

64 Buprenorphine Dosing Most participants were non-tolerant Planned dose induction started low and went slow Dose increased weekly unless otherwise indicated 1, 2, 3, 4, 6, 8, 12, 16 mg daily x 7 days Switched to 32 every other day, then thrice weekly Close observation for diversion: 19 cases diversion (17.9%)

65 Participant Characteristics (N = 211) Variables Age (Mean/SD) 39.1 (8.8) African American White 70.1% 25.6% Male 70.1% Prior OAT 47% Days of heroin use, 30 days prior to incarceration (Mean/SD) 24.5 (10.1)

66 Prison & Community Treatment Entry Outcomes p =.006 p=.01

67 Conclusion Starting buprenorphine in prison, as with starting methadone in prison (Kinlock and McKenzie studies), was associated with significantly higher rates of post-release treatment entry Attempted diversion was a problem (as with Magura and coworkers study) that may hamper use of buprenorphine in prison settings 12 month treatment outcomes will be reported soon

68 Extended-Release Naltrexone (XR-NTX) to Prevent Relapse After Release from Jail Pilot random assignment study 34 sentenced inmates in NYC jail with h/o opioid dependence Did not want OAT Random assignment to: 1) XR-NTX injection prior to release and offered two further injections one month apart in the community 2) Treatment-as-usual with one counseling session and referral information F/U at 1, 2, 3, 4, and 8 weeks after release Lee et al., Addiction, 2015

69 Outcomes Starting XR-NTX was a feasible and promising intervention XR-NTX (n=16) TAU (n=17) p Opioid relapse weeks (50%) 16 (93%) <.03 % Negative urine drug tests 59% (34/57) 24% (15/62) <.0001

70 Limitations & Future Direction Small sample Limited follow-up period Large two-site random assignment study underway as part of SOMATICS study

71 Future Directions Implementation and policy research on increasing medication penetration in jails in US Trials to test approaches to increase treatment entry post-release Trials to test approaches to increase treatment retention for individuals re-entering community care post-release Ongoing trials will provide data on use of extended release naltrexone among inmates and probationers, patient navigation, and naloxone provided post-release

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