drugset / Trial / NCT00955162

Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")

NCT00955162

Phase 4 Completed 270 enrolled Indivior Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries. Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals. Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.

Timeline

Start
2009-08
Primary completion
2010-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified Other
Subject Naloxone Small molecule Other

Indications