Phase 3
Completed N=665
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
opioid dependence · Opioid Related Disorders
Source: ClinicalTrials.gov NCT02357901 ↗
Enrolled (actual)
665
Serious AEs
3.2%
Results posted
Feb 2018
Primary outcomePrimary: 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
◆ Published Evidence
Established
41citations · ~8 / year
Assessment of craving in opioid use disorder: Psychometric evaluation and predictive validity of the opioid craving VAS.
Summary
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
Linked Publications (5)
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Assessment of craving in opioid use disorder: Psychometric evaluation and predictive validity of the opioid craving VAS.
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Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder.
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Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study.
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Examining the benefit of a higher maintenance dose of extended-release buprenorphine in opioid-injecting participants treated for opioid use disorder.
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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 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 | — |
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) 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.