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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Buprenorphine Extended-Release	Buprenorphine Extended Release	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.
Sublingual Buprenorphine	Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Recruitment & Eligibility