Assessing Optimal XR-Buprenorphine Initiation Points in Jail
Key facts
- Who runs it
- NYU Langone Health
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 4
- Started
- 1 Nov 2023
- Ended
- 1 Feb 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Extended-Release Buprenorphine Injection
- Record updated
- 29 February 2024
- Why it stopped
- This study was not initiated due to policy changes in Massachusetts (the proposed study sites).
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- NYU Langone HealthNew York, United States
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- XR-B Induction at AdmissionTreatment being tested
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.
Treatment: Extended-Release Buprenorphine Injection
- XR-B Induction at Pre-ReleaseTreatment being tested
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.
Treatment: Extended-Release Buprenorphine Injection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 February 2024