Assessing Optimal XR-Buprenorphine Initiation Points in Jail
A legfontosabb adatok
- Ki végzi
- NYU Langone Health
- Hol
- New York (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Fázis
- 4. fázis
- Kezdés
- 2023. nov. 1.
- Befejezés
- 2026. febr. 1.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Extended-Release Buprenorphine Injection
- A regiszteradat frissítve
- 2024. február 29.
- Miért állt le
- This study was not initiated due to policy changes in Massachusetts (the proposed study sites).
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- Incarcerated adults able to provide written informed consent in English
- Currently sentenced with pending release date between 3-7 months
- Current moderate-to-severe opioid use disorder (DSM-5)
- Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)
- Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release
Ki nem vehet részt
- On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community
- Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate
- Allergy, hypersensitivity or medical contraindication to either medication
- Pregnancy, planning conception, or breast-feeding
- Chronic pain requiring opioid pain management
Helyszínek itt: Egyesült Államok
- NYU Langone HealthNew York, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).
A vizsgálat 2 csoportja
- XR-B Induction at AdmissionA vizsgált kezelés
Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission. XR-B will be continued monthly from the time of induction to the day of release (up to 6 months), and up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
Kezelés: Extended-Release Buprenorphine Injection
- XR-B Induction at Pre-ReleaseA vizsgált kezelés
Participants will initiate extended-release buprenorphine (XR-B) treatment within 30 days of release. Participants will receive at least one XR-B monthly injection prior to release, and XR-B will be continued monthly from the time of induction to the day of release. Up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
Kezelés: Extended-Release Buprenorphine Injection
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2024. február 29.