Assessing Optimal XRB Initiation Points in Jail

Study Overview
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Brief Summary
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This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.

Official Title
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Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Drug: Extended-Release Buprenorphine (XRB)
* Drug: Sublingual Buprenorphine (SLB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incarcerated men able to provide written informed consent in English.* Unsentenced. Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days. Minimum anticipated jail stay is 4 days. Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated). Exclusion Criteria: Sentenced. Allergy, hypersensitivity or medical contraindication to either medication. Chronic pain requiring opioid pain management or other contraindicated medications.
Sexes Eligible for Study
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Male

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transition to Extended-Release Buprenorphine (XRB)<br>Participants randomized to transition to treatment with XRB. | Drug: Extended-Release Buprenorphine (XRB)<br>* XRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB 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. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release.<br>* Other names: Sublocade;|
| Active Comparator: Sublingual Buprenorphine (SLB) Maintenance<br>Participants randomized to remain on-treatment with SLB. | Drug: Sublingual Buprenorphine (SLB)<br>* Maintenance of existing SLB prescription (treatment as usual).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants released from jail with at least 7 days of buprenorphine in their system | The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records. | Up to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants continuing MOUD treatment in the community | Percentage of participants who continue to access medication for opioid use disorder (MOUD) once released from jail. This will be based on community clinic records indicating admission and retention. | Up to Month 9 |