Open-Label Treatment Extension Study

Completed · Phase 3

Conditions studied: Opioid Use Disorder, Opioid-related Disorders

In brief

Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.

Key facts

Study ID

NCT02896296

Run by

Indivior Inc.

People needed

208

Starts

2016-08-17

Expected to finish

2017-08-23

Last updated by the study team

2018-11-29

Who can join

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

You may qualify if…

• Provide written consent to participate in this study.
• Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).
• Be considered eligible in the medical judgment of the Investigator.
• Females: Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent form (ICF)) must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 6 months after the last dose of investigational medicinal product (IMP).
• Males: Subjects with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the ICF through at least 6 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
• Subjects must agree not to take any buprenorphine products other than those administered during the current study throughout participation in the study.
• Subjects must be willing to adhere to study procedures.

You may not qualify if…

• Subject compliance issues during participation in the RB-US-13-0003 study which, in the opinion of the Investigator, could potentially compromise subject safety.
• Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or failing to use adequate contraceptive methods during the study.
• History of suicidal ideation within 28 days prior to signing the ICF as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment for the current study), or history of a suicide attempt (per the C-SSRS) in the 6 months prior to signing the ICF.
• Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the potential to prolong QTc within 28 days of Day 1 unless prior written approval was obtained from the Medical Monitor.

Where it is running

• Boyett Health Services — Hamilton, Alabama, United States
• Woodland International Research Group — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network — Long Beach, California, United States
• Pacific Research Partners — Oakland, California, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Amit Vijapura — Jacksonville, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Innovative Clinical Research — Lauderhill, Florida, United States
• Scientific Clinical Research — North Miami, Florida, 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
• St Louis Clinical Trials — St Louis, Missouri, United States
• Altea Research — Las Vegas, Nevada, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Neuro-behavioral Clinical Research — Canton, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Rakesh Ranjan MD & Associates, Inc. — Garfield Heights, Ohio, United States
• Pahl Pharmaceutical Professionals — Oklahoma City, Oklahoma, United States
• SP Research, PLLC — Oklahoma City, Oklahoma, United States
• CODA — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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