Evaluation of Preference for a Buprenorphine-based Maintenance Therapy, After a Switch From Buprenorphine Alone (Subutex®) to the Buprenorphine/Naloxone Combination (Suboxone®), in Opioid-dependent Patients With Buprenorphine Maintenance Therapy

NCT00684073 Phase 4 COMPLETED Results posted

This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.

Details

Lead sponsor	Indivior Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	60
Start date	2007-07
Completion	2007-12

Conditions

• Opiate-related Disorders
• Opiate Dependence
• Drug Abuse

Interventions

• buprenorphine
• buprenorphine/naloxone

Primary outcomes

• Subject's Self Assessment Using 10 cm Visual Analogue Scale (VAS) of Overall Preference for One of the Two Buprenorphine-based Maintenance Therapies (Suboxone® or Subutex®). — Each treatment Day (post-dose on days 1-5)
  Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"