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

NYU Langone Health52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid Dependence

Interventions

Buprenorphine Extended ReleaseDRUG

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.

Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Bellevue Hospital Center

New York, New York, United States

Outcomes

Primary Outcomes

# 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

Time frame: 8 Weeks

# of Participants Retained on Their Randomly Assigned Treatment at Week 8

Retained on assigned treatment at Week 8

Time frame: 8 weeks

Mean # of Weeks (0-8) on Any Buprenorphine Treatment

Weeks (0-8) on buprenorphine treatment, mean (SD)

Time frame: 8 weeks

Urine Samples Opioid-negative

number of opioid-negative urine samples

Time frame: 8 weeks

the # of Participants Re-incarcerated

Re-incarceration

Time frame: 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

Time frame: Post-randomization and pre-release, (0-3 months)

Secondary Outcomes

The # of Participants That Received Their Randomly Assigned Study Medication

Received assigned study medication

Time frame: 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

Data from ClinicalTrials.gov

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