Phase 3
Completed N=208
Open-Label Treatment Extension Study
Opioid Use Disorder · Opioid-related Disorders
Source: ClinicalTrials.gov NCT02896296 ↗
Enrolled (actual)
208
Serious AEs
2.4%
Results posted
Nov 2018
Primary outcomePrimary: Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period — 71; 14; 5; 0 Participants
◆ Published Evidence
Emerging
13citations · ~3 / year
Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study.
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.
Linked Publications (2)
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Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study.
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18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period |
71; 14; 5; 0; 0; 8 | — |
| PRIMARY Percentage Change From Baseline to Week 25 in Vital Signs |
1.93; 2.61; 0.13; 6.04; 0.67; 0.02 | — |
| PRIMARY Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values |
1; 1; 1; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02896296) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.