Assessing Optimal XR-Buprenorphine Initiation Points in Jail

Study Overview
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Brief Summary
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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).

Official Title
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Assessing Optimal XR-Buprenorphine Initiation Points in Jail

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: Extended-Release Buprenorphine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XR-B Induction at Admission<br>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. | Drug: Extended-Release Buprenorphine Injection<br>* Extended-release buprenorphine (XR-B, Sublocade) is manufactured by Indivior. XR-B consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades.<br>* Other names: Sublocade;|
| Experimental: XR-B Induction at Pre-Release<br>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. | Drug: Extended-Release Buprenorphine Injection<br>* Extended-release buprenorphine (XR-B, Sublocade) is manufactured by Indivior. XR-B consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades.<br>* Other names: Sublocade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release | Data derived from clinic records. | Up to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period | Includes initiation of MOUD other than XR-B. | Up to Month 6 | 
| Number of Days of Opioid Use at 1 Month Post-Release | 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. | 1 Month Post-Release (Up to Month 7) | 
| Number of Days of Opioid Use at 3 Months Post-Release | 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. | 3 Months Post-Release (Up to Month 10) | 
| Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period | 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. | Up to Month 6 | 
| Mean K-6 Distress Scale Score during Incarceration Period | 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. | Up to Month 6 | 
| Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release | Data derived from clinic records. | 1 Month Post-Release (Up to Month 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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XR-Buprenorphine, Sublocade, Medication for Opioid Use Disorder (MOUD)