Clinical trial NCT04219540: Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
Official title: Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid-use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-01-07
Enrollment: 675
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 criteria: 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. \[Current CJS-involvement is defined as either 1) release from any CJS incarceration or detention, or 2) under community supervision (includes parole, probation, drug or other treatment court, or other alternative to incarceration supervision) within 6 months prior to study enrollment (the date of a signed ICF)\].
* (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.

Primary outcomes:
measure: Number of Injections during 24-Week Post-Release Treatment Phase
timeFrame: Up to Week 24
Secondary outcomes:
measure: Change in Opioid use
timeFrame: Weeks 0, 4, 8, 12,16, 20, 24, 52
measure: Change in Opioid treatment outcomes - adverse events
timeFrame: Weeks 0, 4, 8, 12,16, 20, 24, 52
measure: Change in Opioid treatment outcomes - lifestyle changes
timeFrame: Weeks 0, 4, 8, 12,16, 20, 24, 52
measure: Change in Opioid treatment outcomes - HIV changes
timeFrame: Weeks 0, 24
measure: Change in criminal justice system (CJS) involvement with XR-B versus XR-NTX
timeFrame: Weeks 4, 8, 12,16, 20, 24, 52
measure: Change in Non-randomized Treatment-As-Usual retention compared to XR-B/XR-N.
timeFrame: Weeks 4, 8, 12,16, 20, 24, 52
measure: Change in Non-randomized Treatment-As-Usual rates of OUD
timeFrame: Weeks 4, 8, 12,16, 20, 24, 52
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: NYU Langone
name: Joshua Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: