Phase 3
N=665
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
Opioid Dependence · Opioid Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02357901 ↗Enrolled (actual)
665
Serious AEs
3.2%
Results posted
Feb 2018
Primary outcome: Primary: Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 — 194; 196; 99; 139 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SUBOXONE (Drug); RBP-6000 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 |
194; 196; 99; 139; 126; 11 | <0.0001 sig |
| SECONDARY Percentage of Participants Considered A Treatment Success |
28.4; 29.1; 2.0 | <0.0001 sig |
| SECONDARY Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24 |
194; 196; 99; 140; 129; 17 | <0.0001 sig |
| SECONDARY Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24 |
194; 196; 99; 163; 162; 37 | <0.0001 sig |
| SECONDARY Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures |
2.1; -0.9; 11.5 | 0.0003 sig |
| SECONDARY Participants Who Complete the Week 24 Visit ("Completers") |
119; 126; 33 | <0.0001 sig |
| SECONDARY Participants Who Are Abstinent at Week 24 |
71; 87; 2 | <0.0001 sig |
| SECONDARY Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures |
1.6; 1.5; 2.4 | <0.0001 sig |
| SECONDARY Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures |
-0.7; -0.7; -0.0 | <0.0001 sig |
| SECONDARY Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures |
-0.5; -1.1; -0.1 | 0.3143 |
| SECONDARY Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures |
-0.9; -2.0; 0.7 | 0.0726 |
| SECONDARY Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 |
8.5; 8.5; 1.0 | <0.0001 sig |
| SECONDARY Participants With Adverse Events During the Treatment Period |
155; 134; 56; 67; 70; 23 | — |
| SECONDARY Worst Injection Site Pain From Injections 1-6 as Measured by Participant-Reported Visual Analog Scale (VAS) |
55.8; 63.3; 61.0 | — |
| SECONDARY Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24 |
15; 11; 9; 6; 1; 2 | — |
Summary
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
Eligibility Criteria
Inclusion Criteria
- Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder
- By medical history has met DSM-5 criteria for moderate or severe opioid use disorder for the 3 months immediately prior to signing the informed consent form
- Is seeking medication-assisted treatment for opioid use disorder
- Is an appropriate candidate for opioid partial-agonist medication-assisted treatment in the opinion of the investigator or medically responsible physician
- Body mass index (BMI) of ≥ 18.0 to ≤ 35.0 kg/m^2
Exclusion Criteria
- Current diagnosis other than opioid use disorder requiring chronic opioid treatment
- Current substance use disorder as defined by DSM-5 criteria with regard to any substances other than opioids, cocaine, cannabis, tobacco, or alcohol.
- Positive urine drug screen (UDS) result at screening for cocaine or cannabis AND meets DSM-5 criteria for either moderate or severe cocaine or cannabis use disorder, respectively
- Meets DSM-5 criteria for moderate or severe alcohol use disorder
- Received medication-assisted treatment for opioid use disorder (e.g., methadone, buprenorphine) in the 90 days prior to providing written informed consent
Data sourced from ClinicalTrials.gov (NCT02357901). 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.