Phase
Condition
Opioid Use Disorder
Treatment
XR-NTX
XR-B (SUBLOCADETM)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
XR-B vs. XR-NTX Inclusions:
(1) Adult volunteer aged 18 years or older able to provide written informed consentin English (or Spanish at some sites)
(2) Current CJS incarceration (residing in a controlled environment) with pendingrelease date (within 6 months of randomization) OR community CJS-involvement definedas: a) Current CJS incarceration (residing in a controlled environment) with pendingrelease date (within 6 months of anticipated randomization), or; b)Community-dwelling volunteers with current CJS-involvement. [Current CJS-involvementis defined as either 1) release from any CJS incarceration or detention, or 2) undercommunity supervision (includes parole, probation, drug or other treatment court, orother alternative to incarceration supervision) within 6 months prior to studyenrollment (the date of a signed ICF)].
(3) Current or history of moderate-to-severe opioid use disorder in the past yearprior to incarceration (OUD, DSM-5)
(4) Not planning to move out of state or to new location within 6-monthspost-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
Exclusion Criteria:
XR-B vs. XR-NTX Exclusions:
(6) Medical or psychiatric disorders making participation unsafe or regularfollow-up unlikely, (such as suicidal ideation or pre-existing moderate to severehepatic 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 forpast 30 days prior to incarceration or monthly XR-NTX or XR-BUP 30 days or longerprior to incarceration AND intending to remain on same form of methadone orbuprenorphine or XR-NTX maintenance now and upon return to the community (i.e., wasin MOUD treatment pre-incarceration, on same MOUD treatment now, and plans tocontinue same MOUD treatment post-incarceration). (Note - If community-dwelling,already on non-study methadone, buprenorphine, or naltrexone for 30 days or longerat 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.
Study Design
Study Description
Connect with a study center
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesActive - Recruiting
Friends Research Institute
Baltimore, Maryland 21201
United StatesActive - Recruiting
Dartmouth College
Hanover, New Hampshire 03755
United StatesActive - Recruiting
Rutgers University
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97219
United StatesActive - Recruiting
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