Overview

Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone

Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Naltrexone