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 StatesSite Not Available
Friends Research Institute
Baltimore, Maryland 21201
United StatesSite Not Available
Dartmouth College
Hanover, New Hampshire 03755
United StatesSite Not Available
Rutgers University
New Brunswick, New Jersey 08901
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97219
United StatesSite Not Available
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