drugset
drugset / Trial / NCT01690546

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

NCT01690546 ↗

Phase 2 Completed 38 enrolled Paolo Mannelli Alkermes, Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.

Timeline

Start
2012-09
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 0.25 mg Other
Subject Naltrexone Small molecule 1 mg Other
Subject Naltrexone Small molecule 2 mg Other
Subject Naltrexone Small molecule 6 mg Other
Subject Naltrexone Small molecule 10 mg Other
Subject Naltrexone Small molecule 50 mg Other
Subject Naltrexone Small molecule 380 mg Other
Subject buprenorphine/naloxone Unknown 2 mg —

Indications

opiate dependence