Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder

• Status: Completed
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

Summary

A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

De novo subjects:

• Seeking treatment for opioid use disorder (OUD) and for the previous 3 months meet the Diagnostic and Statistical Manual 5 (DSM-5) criteria for moderate or severe OUD

• Appropriate candidate for opioid partial-agonist treatment

• BMI between 18 and 35, inclusive

Roll-over subjects:

• Completed RB-US-13-0001

Exclusion Criteria:

De novo subjects:

• Current diagnosis, other than OUD, requiring chronic opioid treatment

• Current substance use disorder with regard to substances other than opioids, cocaine, cannabis, tobacco or alcohol

• Received medication-assisted treatment for OUD in the 90 days prior to informed consent

• Use (within past 30 days prior to informed consent) or positive urine drug screen (UDS) at screening for barbiturates, benzodiazepines,methadone or buprenorphine

• Treatment for OUD required by court order

• History of recent suicidal ideation or attempt

Roll over subjects:

• Experienced major protocol deviations or adverse events in RB-US-13-0001 which could potentially compromise subject safety

• Discontinued early from study RB-US-13-0001