NCT02896296

Open-Label Treatment Extension Study

An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multi-center, open-label, RBP-6000 treatment extension study in which subjects who have completed the End of Study (EOS) procedures for study RB-US-13-0003 are eligible. EOS assessments completed at the RB-US-13-0003 EOS visit serve as part of the screening visit for this study. In addition, subjects were requested to complete a Columbia Suicide Severity Rating Scale (C-SSRS) baseline/screening survey and a medical history and height was obtained. The informed consent may be shared with subjects up to 2 months prior to the RB-US-13-0003 EOS visit, however should not be signed until all assessments for the EOS visit have been completed. On Day 1, eligible subjects receive a subcutaneous (SC) injection of RBP-6000 at a low or high dose based on the medical judgment of the investigator. After the injection, vital signs and the injection site were assessed. Prior to departing the site, subjects were also assessed for adverse events (AEs) and use of concomitant medications (ConMeds). Subjects return to the site for monthly injection visits every 28 days (-2 / +7 days) for a total of up to 6 injections (participants were not required to complete all 6 injections). At each subsequent visit (Injections 2 through 6) the following procedures / assessments were performed : urine pregnancy test performed for all female subjects who are of childbearing potential before each injection; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; vital signs collected pre and post each injection; RBP-6000 injection, urine drug screen (UDS); C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; local injection site grading, subject self-assessment of injection site pain (Injection Site Pain Visual Analog Scale \[VAS\]), assessment for adverse events (AEs). Laboratory tests (hematology, chemistry and urinalysis) may be requested by the Investigator on an ad-hoc basis in order to assess for AEs. A subject's alternative treatment options were assessed at least two months before EOS at each visit. At EOS or early termination (ET), the following assessments were performed: urine pregnancy test performed for all female subjects who are of childbearing potential; vital signs; previous injection site assessed for potential reaction and evidence of attempts to remove the depot; UDS; C-SSRS since last visit assessment, counseling (manual-guided behavioral therapy); use of ConMeds; assessment for AEs; a brief physical exam; height and body weight were measured and a subject's body mass index (BMI) and waist-to-hip ratio calculated; laboratory tests (hematology, chemistry, urinalysis). Subjects were to be contacted by telephone approximately 4 weeks after EOS/ET for a safety follow-up assessment of AEs and use of ConMeds.

Conditions

• Opioid Use Disorder
• Opioid-related Disorders

Interventions

Type	Name	Description
DRUG	RBP-6000	Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator.

Timeline

• Start date: 2016-08-17
• Primary completion: 2017-08-23
• Completion: 2017-08-23
• First posted: 2016-09-12
• Last updated: 2018-11-29
• Results posted: 2018-11-02

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated drug study