Overview
This study seeks to compare the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This open-label, non-inferiority, head-to-head study design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of XR-B (and XR-NTX) as potentially useful re-entry and relapse prevention treatment options. It is hypothesized that XR-B is non-inferior to XR-NTX when comparing retention-in-study-medication treatment options.
Description
Participants eligible for randomization will be randomized 1:1 to extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) prior to release from the correctional controlled environment (including jails, prisons, work release and residential treatment, or other correctional facilities) and treated for 24-weeks following release or upon entry into a community CJS-mandated program.
XR-B (SublocadeTM, Indivior) is a partial opioid agonist indicated for the treatment of moderate to severe opioid use disorder. Delivered as a pre-filled 2cc subcutaneous monthly injection, typically using two 300mg/1.5 ml initial starting doses followed by 100mg/0.5 ml monthly maintenance doses. The study will provide up to six monthly XR-B doses throughout the study. Prior to an initial injection, the participant must be stable for seven days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher.
Description of Study Intervention Participants eligible for randomization (n=670) will be randomized 1:1 to extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX) prior to release from the correctional controlled environment (including jails, prisons, work release and residential treatment, or other correctional facilities) and treated for 24-weeks following release or upon entry into a community CJS-mandated program.
XR-B (SublocadeTM, Indivior) is a partial opioid agonist indicated for the treatment of moderate to severe opioid use disorder. Delivered as a pre-filled 2cc subcutaneous monthly injection, typically using two 300mg/1.5 ml initial starting doses followed by 100mg/0.5 ml monthly maintenance doses. The study will provide up to six monthly XR-B doses throughout the study. Prior to an initial injection, the participant must be stable for seven days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher.
XR-NTX (Vivitrol®, Alkermes) is an opioid antagonist indicated for the prevention of opioid dependence, following detoxification. A negative opioid urine toxicology, negative self-report of any recent opioid use, and a naloxone challenge. The naloxone challenge consists of 0.4-0.8mg of IV/SC/IM naloxone followed by the observation of no opioid withdrawal symptoms, or the use of oral naltrexone (12.5-25mg) followed by 1-2 hours of observation. XR-NTX is delivered as a 380mg (4cc) intramuscular injection to the upper outer gluteus (buttock) monthly. The study will provide six or more monthly XR-NTX doses.
Eligibility
Inclusion Criteria:
XR-B vs. XR-NTX Inclusions:
- (1) Adult volunteer aged 18 years or older able to provide written informed consent in English (or Spanish at some sites)
- (2) Current CJS incarceration (residing in a controlled environment) with pending
release date (within 6 months of randomization) OR community CJS-involvement defined
as: a) Current CJS incarceration (residing in a controlled environment) with pending
release date (within 6 months of anticipated randomization), or; b) Community-dwelling
volunteers with current CJS-involvement. [Current CJS-involvement is defined as either
- release from any CJS incarceration or detention, or 2) under community supervision (includes parole, probation, drug or other treatment court, or other alternative to incarceration supervision) within 6 months prior to study enrollment (the date of a signed ICF)].
- (3) Current or history of moderate-to-severe opioid use disorder in the past year
prior to incarceration (OUD, DSM-5)
- (4) Not planning to move out of state or to new location within 6-months post-release (reasonable chance they can complete 6 months of follow-up visits).
- (5) Willing to accept either XR-B or XR-NTX assignment.
Non-randomized TAU Inclusions:
• Recruited prior to launch of RCT or not interested in or appropriate for randomization to
XR-B or XR-NTX assignment (i.e, already on methadone pre-release), but are otherwise
eligible based on inclusion (#1-4, above) and exclusion (#6-10, below).
Exclusion Criteria:
XR-B vs. XR-NTX Exclusions:
- (6) Medical or psychiatric disorders making participation unsafe or regular follow-up
unlikely, (such as suicidal ideation or pre-existing moderate to severe hepatic
impairment)
- (7) Pregnancy, planning conception, or breast-feeding
- (8) Allergy, hypersensitivity or medical contraindication to either medication
- (9) Chronic pain requiring opioid pain management
- (10) On daily stable methadone or buprenorphine (SL-B) maintenance every day for past
30 days prior to incarceration or monthly XR-NTX or XR-BUP 30 days or longer prior to
incarceration AND intending to remain on same form of methadone or buprenorphine or
XR-NTX maintenance now and upon return to the community (i.e., was in MOUD treatment
pre-incarceration, on same MOUD treatment now, and plans to continue same MOUD
treatment post-incarceration). (Note - If community-dwelling, already on non-study
methadone, buprenorphine, or naltrexone for 30 days or longer at the time of
enrollment, and planning on continuing same.)
Non-randomized TAU Exclusions:
• Currently treated with non-study MOUD while currently incarcerated and for 30+ days prior
to incarceration, or, if community-dwelling, currently on MOUD for 30 days or longer at the
time of enrollment.