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

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Opioid Dependence

Treatments: Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets); Drug: Buprenorphine Extended Release

Study type: Interventional

Funder types: Other

Identifiers

NCT03604159

18-00823

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Buprenorphine Extended-Release

Experimental group

Description:

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.

Treatment:

Drug: Buprenorphine Extended Release

Sublingual Buprenorphine

Active Comparator group

Description:

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.

Treatment:

Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)