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

Completed · Phase 3

Conditions studied: Opioid Use Disorder, Opioid-related Disorders

In brief

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.

Key facts

Study ID

NCT02510014

Run by

Indivior Inc.

People needed

775

Starts

2015-07-27

Expected to finish

2017-01-31

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Haleyville Clinical Research — Haleyville, Alabama, United States
• Boyett Health Services — Hamilton, Alabama, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• Behavioral Research Specialists — Glendale, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Pacific Research Partners — Oakland, California, United States
• North County Clinical Research — Oceanside, California, United States
• Neuropsychiatric Research Center of Orange County — Orange, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Amit Vijapura — Jacksonville, Florida, United States
• Sarkis Clinical Trials — Lake City, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Innovative Clinical Research — Lauderhill, Florida, United States
• Florida Clinical Research Center — Maitland, Florida, United States
• Try Research — Maitland, Florida, United States
• Scientific Clinical Research — North Miami, Florida, United States
• Research Centers of America — Oakland Park, Florida, United States
• Atlanta Institute of Medicine and Research — Alpharetta, Georgia, United States
• Phoenix Medical Research — Prairie Village, Kansas, United States
• Louisiana Research Associates — New Orleans, Louisiana, United States
• Louisiana Clinical Research — Shreveport, Louisiana, United States
• Stanley Street Treatment and Resources — Fall River, Massachusetts, United States
• Adams Clinical Trials — Watertown, Massachusetts, United States
• Precise Research Centers, Inc. — Flowood, Mississippi, United States

Full record on ClinicalTrials.gov

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