Phase 4
N=52
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03604159 ↗Enrolled (actual)
52
Serious AEs
3.9%
Results posted
Jan 2022
Primary outcome: Primary: # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 — 18; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Buprenorphine Extended Release (Drug); Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8 |
18; 9 | — |
| PRIMARY # of Participants Retained on Their Randomly Assigned Treatment at Week 8 |
15; 9 | — |
| PRIMARY Mean # of Weeks (0-8) on Any Buprenorphine Treatment |
6.1; 2.6 | — |
| PRIMARY Urine Samples Opioid-negative |
72; 50 | — |
| PRIMARY the # of Participants Re-incarcerated |
2; 4 | — |
| PRIMARY The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication |
0.11; 1.06 | — |
| SECONDARY The # of Participants That Received Their Randomly Assigned Study Medication |
24; 26 | — |
| SECONDARY The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled |
21; 26 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03604159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.