Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
A legfontosabb adatok
- Ki végzi
- NYU Langone Health
- Hol
- Baltimore, Hanover, New Brunswick, New Haven, New York és Portland (Egyesült Államok)Mind a 6 helyszín megnézése
- Azonosító
- Állapot
- Befejeződött
- Fázis
- 4. fázis
- Résztvevők
- 675 fő vett részt
- Kezdés
- 2021. jan. 7.
- Befejezés
- 2025. febr. 28.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
- A vizsgált kezelések
- XR-B (SUBLOCADETM)
- XR-NTX
- A regiszteradat frissítve
- 2025. május 14.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- (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
- (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)
- (8) Allergy, hypersensitivity or medical contraindication to either medication
- XR-B vs. XR-NTX Exclusions:
- (7) Pregnancy, planning conception, or breast-feeding
- (9) Chronic pain requiring opioid pain management
Helyszínek itt: Egyesült Államok
- Friends Research InstituteBaltimore, Egyesült Államok
- Dartmouth CollegeHanover, Egyesült Államok
- Rutgers UniversityNew Brunswick, Egyesült Államok
- Yale University School Of MedicineNew Haven, Egyesült Államok
- NYU Langone HealthNew York, Egyesült Államok
- Oregon Health and Science UniversityPortland, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 3 csoportja
- extended-release buprenorphine (XR-B)A vizsgált kezelés
Subjects who agree to XR-B treatment will receive an XR-B injection to the abdomen. The injection is a liquid medication in the amount of either 100 or 300 mg buprenorphine in 1.5 cc volume and will last in the body for about 30 days. The medication is stored in a small nodule under the skin of the belly where it was injected. The buprenorphine is gradually released into the body over time for a 30-day period.
Kezelés: XR-B (SUBLOCADETM)
- extended release naltrexone XR-NTXA vizsgált kezelés
Subjects who agree to XR-NTX treatment will receive an injection of XR-NTX to the outer upper part of your buttock. The injection is a liquid medication in the amount of 380 mg naltrexone in 4 cc volume (about 1 teaspoon) and will last in your body for about 30 days. Following release, visits with study physicians at Bellevue Hospital will offer further counseling or medication treatment referrals, the option to receive additional XR-NTX injections once a month following the first injection and continued encouragement to avoid relapses and stay on treatment.
Kezelés: XR-NTX
- Treatment as Usual (TAU)Nincs vizsgálati kezelés, összehasonlításként
In this group you will not receive any study medication. You will be able to receive any treatments available to individuals in the jail or prison who are not in the study. Trained study staff at the first two visits will provide counseling focusing on relapse and overdose prevention, treatment engagement, and navigating re-entry challenges.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2025. május 14.