A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects

NCT00605033 Phase 4 COMPLETED Results posted

Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.

Details

Lead sponsor	Indivior Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	241
Start date	2008-03
Completion	2009-05

Conditions

• Opiate Dependence
• Drug Dependence

Interventions

• Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484
• Subutex, Buprenorphine Hydrochloride, SCH 28444

Primary outcomes

• Response Rate — Assessed by Day 7 of double-blind, double-dummy treatment period.
  Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.