drugset / Trial / NCT03604159
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Phase 4
Completed
52 enrolled
NYU Langone Health
New York City Health and Hospitals Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-06-24
- Primary completion
- 2020-05-04
- Completion
- 2020-05-04
Publications
- Cheng A, Badolato R, Segoshi A, McDonald R, Malone M, Vasudevan K, Badiei B, Sugarman A, Macdonald R, Mangat J, Giftos J, Lee JD, Tofighi B. Perceptions and experiences toward extended-release buprenorphine among persons leaving jail with opioid use disorders before and during COVID-19: an in-depth qualitative study. Addict Sci Clin Pract. 2022 Jan 29;17(1):4. doi: 10.1186/s13722-022-00288-4.
- Lee JD, Malone M, McDonald R, Cheng A, Vasudevan K, Tofighi B, Garment A, Porter B, Goldfeld KS, Matteo M, Mangat J, Katyal M, Giftos J, MacDonald R. Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail. JAMA Netw Open. 2021 Sep 1;4(9):e2123032. doi: 10.1001/jamanetworkopen.2021.23032.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Buprenorphine | Other / unclassified | 4 mg | Other |
| Comparator | Buprenorphine | Other / unclassified | 8 mg | Other |
| Comparator | Buprenorphine | Other / unclassified | 17.1 mg | Other |
| Comparator | Buprenorphine | Other / unclassified | 24 mg | Other |
| Comparator | Buprenorphine | Other / unclassified | 100 mg | Subcutaneous |
| Comparator | Buprenorphine | Other / unclassified | 300 mg | Subcutaneous |