Phase 3
Completed N=775
Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
Opioid Use Disorder · Opioid-related Disorders
Source: ClinicalTrials.gov NCT02510014 ↗
Enrolled (actual)
775
Serious AEs
3.7%
Results posted
Mar 2018
Primary outcomePrimary: Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period — 302; 145; 172; 61 Participants
◆ Published Evidence
Emerging
13citations · ~3 / year
Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study.
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.
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 |
302; 145; 172; 61; 16; 9 | — |
| PRIMARY Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs |
0.2; 1.3; 0.1; 1.6; -1.2; 1.0 | — |
| PRIMARY Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period |
307; 252; 10; 1; 3; 1 | — |
| PRIMARY Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS) |
44.0; 33.5; 39.8; 32.7; 38.9; 30.2 | — |
| SECONDARY Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49) |
2.1; 1.5; -1.0; -0.3; -1.0 | — |
| SECONDARY Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49) |
3.8; 2.8; -1.1; 1.1; -1.6 | — |
| SECONDARY Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49) |
5.9; 4.4; -0.2; 4.2; -2.0 | — |
| SECONDARY Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49) |
412; 257; 315; 206; 278; 200 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02510014) 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.