drugset / Trial / NCT00733720

Buprenorphine Naltrexone-P1 A-Cocaine

NCT00733720

Phase 1 Completed 8 enrolled National Institute on Drug Abuse (NIDA)
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.

Timeline

Start
2008-08
Primary completion
2008-12
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 4 mg Other
Subject Buprenorphine Other / unclassified 8 mg Other
Subject Buprenorphine Other / unclassified 16 mg Other
Subject Naloxone Small molecule 1 mg Other
Subject Naloxone Small molecule 2 mg Other
Subject Naloxone Small molecule 4 mg Other
Subject Naltrexone Small molecule 50 mg Oral

Indications