XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

Study Overview
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Brief Summary
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This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.

Official Title
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Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: Buprenorphine Extended Release
* Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults >18yo incarcerated in NYC jails with known release dates. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence). Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program. Exclusion Criteria: Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB. Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Buprenorphine Extended-Release<br>XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date. | Drug: Buprenorphine Extended Release<br>* XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.<br>* Other names: SUBLOCADE;|
| Active Comparator: Sublingual Buprenorphine<br>SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study. | Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)<br>* SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 | Retained on any form of community buprenorphine treatment at Week 8 | 8 Weeks | 
| # of Participants Retained on Their Randomly Assigned Treatment at Week 8 | Retained on assigned treatment at Week 8 | 8 weeks | 
| Mean # of Weeks (0-8) on Any Buprenorphine Treatment | Weeks (0-8) on buprenorphine treatment, mean (SD) | 8 weeks | 
| Urine Samples Opioid-negative | number of opioid-negative urine samples | 8 weeks | 
| the # of Participants Re-incarcerated | Re-incarceration | 8 weeks | 
| The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication | Jail medical clinic visits per day following study medication induciton, mean | Post-randomization and pre-release, (0-3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The # of Participants That Received Their Randomly Assigned Study Medication | Received assigned study medication | 8 Weeks | 
| The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled | Received assigned study medication prior to release as scheduled | 0-3 months (pre-release) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid dependence, Buprenorphine, primary care treatment, extended-release buprenorphine