Assessing Optimal XR-Buprenorphine Initiation Points in Jail
- Conditions
- Opioid Use Disorder
- Interventions
- Registration Number
- NCT05481112
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
- Pregnancy, planning conception, or breast-feeding
- Allergy, hypersensitivity or medical contraindication to either medication
- Chronic pain requiring opioid pain management
- On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XR-B Induction at Admission Extended-Release Buprenorphine Injection 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. XR-B Induction at Pre-Release Extended-Release Buprenorphine Injection 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.
- Primary Outcome Measures
Name Time Method Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release Up to Month 6 Data derived from clinic records.
- Secondary Outcome Measures
Name Time Method Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period Up to Month 6 Includes initiation of MOUD other than XR-B.
Number of Days of Opioid Use at 1 Month Post-Release 1 Month Post-Release (Up to Month 7) Participants will self-report opioid use using the Timeline Followback (TLFB) method, which asks participants to estimate number of days of drug use over the previous month.
Number of Days of Opioid Use at 3 Months Post-Release 3 Months Post-Release (Up to Month 10) Participants will self-report opioid use using the Timeline Followback (TLFB) method, which asks patients to estimate number of days of drug use over the previous month.
Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period Up to Month 6 Participants indicate their level of craving for opioids by marking a 100mm visual analogue scale where 0 = no craving and 100 = maximal craving. The questionnaire is administered at baseline and then monthly over the incarceration phase.
Mean K-6 Distress Scale Score during Incarceration Period Up to Month 6 K-6 Distress Scale is a 6-item self-report measure of psychological distress. Participants rank each item on a 5-point Likert scale ranging from 0 (None of the time) to 4 (All of the time). The total score is the sum of responses and ranges from 0 to 24; higher scores indicate higher levels of psychological distress. The questionnaire is administered at baseline and then monthly over the incarceration phase.
Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release 1 Month Post-Release (Up to Month 7) Data derived from clinic records.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States