drugset / Trial / NCT00640835

Safety and Tolerability of Buprenorphine/Naloxone Film Strips

NCT00640835

Phase 2 Completed 382 enrolled Indivior Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Timeline

Start
2008-02
Primary completion
2008-10
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 4 mg Subcutaneous
Subject Buprenorphine Other / unclassified 32 mg Subcutaneous
Subject Naloxone Small molecule 1 mg Subcutaneous
Subject Naloxone Small molecule 8 mg Subcutaneous

Indications