drugset / Trial / NCT02294253
Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone
Phase 2/3
Completed
30 enrolled
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA) · collab
NaSingle-groupOpen-labelTreatment
Summary
The investigators will randomize 50 opioid-dependent participants who have initially failed outpatient induction onto XR-NTX; participants will receive buprenorphine/naloxone on a weekly basis for 30 days. Buprenorphine/naloxone will be dispensed weekly during the 30-day stabilization and twice weekly during taper phase, and all patients who successfully complete the detoxification will be offered induction onto XR-NTX. All participants will receive weekly therapy with a study psychiatrist. All participants will receive open-label medication. The primary outcome of this study will be percentage of patients successfully inducted onto XR-NTX. Secondary outcomes will be time to relapse, defined as opioid use or dropout.
Timeline
- Start
- 2014-09
- Primary completion
- 2017-12
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine/naloxone | Unknown | 2 mg | Oral |