drugset / Trial / NCT00679458

Randomized, Double-Blind Cross-Over Trial Of Buprenorphine and Low-Dose Naloxone Versus Buprenorphine

NCT00679458

RandomizedCrossoverQuadruple-blindTreatment

Summary

This study compares two medications for analgesic potency and side effects in a sample of individuals with moderate pain. After screening, eligible participants will be randomly assigned to begin blinded treatment with one of two medications. Participants receive 5 daily doses of medication (no more than 2 days between each dose) followed by crossover to the opposite treatment condition for 5 additional daily doses. Each study day, participants will provide a daily pain assessment, receive administration of study medication, and will then be monitored and assessed for pain and side effects over 6 hours.

Timeline

Start
2008-09
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 0.3 mg Intravenous
Subject Naloxone Small molecule 0.02 mg Intravenous

Indications

No indication recorded.