Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
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®.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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®). [ Time Frame: Each treatment Day (post-dose on days 1-5) ] [ Designated as safety issue: No ]Score of 0 = "Not satisfied at all"; Score of 10 = "Totally satisfied"
|Study Start Date:||July 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Subutex® for first two days of study followed by Suboxone® for last 3 days of study
2 mg buprenorphine and 8 mg buprenorphine tablets at doses from 2 to 16 mg buprenorphine daily for first two days of study
Other Name: Subutex®; SCH 028444Drug: buprenorphine/naloxone
2/0.5 mg buprenorphine/naloxone and 8/2 mg buprenorphine/naloxone tablets at doses from 2/0.5 mg buprenorphine/naloxone to 16/4 mg buprenorphine/naloxone daily for last 3 days of study
Other Name: Suboxone®; SCH 000484