Phase 2
N=39
Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
Opioid Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02044094 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question "Do You Like the Drug?" Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures — 1.447; 5.103; 8.374; 1.850 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buprenorphine (Drug); buprenorphine and naloxone (Drug); hydromorphone (Drug); placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question "Do You Like the Drug?" Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures |
1.447; 5.103; 8.374; 1.850; 2.436; 4.750 | — |
| SECONDARY Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures |
4.984; 7.121; 7.042; 4.767; 5.379; 5.708 | — |
| SECONDARY Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12 |
2.070; 2.336; 2.479; 1.753; 2.075; 2.387 | — |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAE) |
39; 29; 26; 25; 25; 0 | — |
| SECONDARY Plasma Concentrations of Buprenorphine Summarized by Study Week |
0.000; 0.000; 0.000; 2.030; 2.164; 2.042 | — |
| SECONDARY Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week |
0.000; 0.000; 0.000; 67.077; 67.875; 67.089 | — |
| SECONDARY Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
0.93; 0.89; 0.27; 0.41; 0.32; 0.63 | — |
| SECONDARY Visual Analog Scale (VAS) Score for "Do You Like the Drug?" by Study Week Analyzed by Mixed Model for Repeated Measures |
2.892; 48.252; 63.503; 1.447; 5.103; 8.374 | — |
| SECONDARY Change From Placebo in VAS Score for "Do You Like the Drug?" by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
45.36; 60.61; 3.66; 6.93; 0.59; 2.90 | — |
| SECONDARY VAS Score for "How High Are You Right Now?" by Study Week Analyzed by Mixed Model for Repeated Measures |
2.654; 33.052; 53.597; 1.386; 4.444; 6.240 | — |
| SECONDARY Change From Placebo in VAS Score for "How High Are You Right Now?" by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
30.40; 50.94; 3.06; 4.85; 0.52; 3.15 | — |
| SECONDARY VAS Score for "Do You Feel Any Drug Effect?" by Study Week Analyzed by Mixed Model for Repeated Measures |
3.274; 39.047; 58.912; 1.200; 4.214; 6.433 | — |
| SECONDARY Change From Placebo in VAS Score for "Do You Feel Any Drug Effect?" by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
35.77; 55.64; 3.01; 5.23; 1.01; 3.69 | — |
| SECONDARY VAS Score for "Does the Drug Have Any Good Effects?" by Study Week Analyzed by Mixed Model for Repeated Measures |
3.131; 43.888; 61.640; 1.239; 4.252; 7.072 | — |
| SECONDARY Change From Placebo in VAS Score for "Does the Drug Have Any Good Effects?" by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
40.76; 58.51; 3.01; 5.83; 0.60; 3.50 | — |
| SECONDARY VAS Score for "Does the Drug Have Any Bad Effects?" by Study Week Analyzed by Mixed Model for Repeated Measures |
4.797; 7.145; 11.046; 1.117; 1.159; 1.107 | — |
| SECONDARY Change From Placebo in VAS Score for "Does the Drug Have Any Bad Effects?" by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
2.35; 6.25; 0.04; -0.01; 0.14; 0.53 | — |
| SECONDARY VAS Score for "Do You Feel Sedated?" by Study Week Analyzed by Mixed Model for Repeated Measures |
3.399; 14.504; 30.979; 1.199; 3.979; 5.401 | — |
| SECONDARY Change From Placebo in VAS Score for "Do You Feel Sedated?" by Study Week and Simulated mu Opioid Receptor Occupancy (μORO) |
11.10; 27.58; 2.78; 4.20; 0.38; 3.92 | — |
Summary
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the effects of exogenous opioids.
The primary objective of this study was to demonstrate that the "Drug Liking" visual analog scale (VAS) measured after challenge with 6 mg (Dose 1) and 18 mg (Dose 2) hydromorphone was noninferior to the "Drug Liking" visual analog scale (VAS) measured after challenge with placebo at Weeks 1-4 post first injection of subcutaneous buprenorphine 300 mg (RBP-6000).
Eligibility Criteria
Inclusion Criteria
- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder at screening and are not seeking opioid use disorder treatment
- Body mass index of >= 18.0 to <= 33.0 kg/m^2
- 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) must have negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of study drug
- Male subjects with female partners of child-bearing potential must agree to use medically acceptable contraception from screening through at least 3 months after the last dose of study drug
Exclusion Criteria
- Subjects with any current diagnosis requiring chronic opioid treatment
- Subjects who currently meet the criteria for diagnosis of moderate or severe substance use disorder by DSM-5 criteria for any substances other than opioids, caffeine, or nicotine.
- Subjects who have abused or used buprenorphine within 14 days prior to informed consent.
Other protocol-defined criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02044094). 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.