Transfer of Subjects From Subutex/Suboxone to RBP-6300

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• Be Male or non-pregnant, non-lactating females

• Be at least 18 years of age

• Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual-IV-TEXT REVISION)criteria for opioid dependence at screening

• Be on stable dose of 8, 16, or 24mg/day for about 30 days prior to screening

• Female subjects of childbearing potential must have a negative urine test prior to enrollment into the study

Exclusion Criteria:

• Have participated in an experimental drug or device study within the last 60 days

• If female, be breast feeding or lactating

• Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study

• Have a clinically significant abnormal finding (in the opinion of the investigator)