drugset / Trial / NCT02038790

Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

NCT02038790

Phase 4 Completed 33 enrolled Indivior Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.

Timeline

Start
2013-11
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 5.7 mg Other
Subject Buprenorphine Other / unclassified 8 mg Other
Subject Naloxone Small molecule 1.4 mg Other
Subject Naloxone Small molecule 2 mg Other

Indications