drugset / Trial / NCT04408313
Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving Jail
RandomizedParallel-groupOpen-labelTreatment
Summary
The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.
Timeline
- Start
- 2020-10-28
- Primary completion
- 2026-05-30
- Completion
- 2026-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 8 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 16 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 24 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 32 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 64 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 96 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 128 mg | Subcutaneous |
| Comparator | Naltrexone | Small molecule | 4 ml | Intramuscular |
| Comparator | Naltrexone | Small molecule | 380 mg | Intramuscular |