Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
Opioid Dependence, Opioid Related Disorders
About this trial
This is an interventional treatment trial for Opioid Dependence
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
Sites / Locations
- Haleyville Clinical Research
- Boyett Health Services
- Woodland International Research Group
- Collaborative Neuroscience Network
- Behavioral Research Specialists
- Synergy Clinical Research Center
- North County Clinical Research
- Artemis Institute for Clinical Research
- Care Practice
- Southern California Research
- Amit Vijapura
- Meridien Research
- Innovative Clinical Research
- Florida Clinical Research Center
- Try Research
- Scientific Clinical Research
- Research Centers of America
- Behavioral Health Care Associates
- Phoenix Medical Research
- Louisiana Research Associates
- Louisiana Clinical Research
- Stanley Street Treatment and Resources
- Adams Clinical Trials
- Precise Research Centers, Inc.
- St Louis Clinical Trials
- Altea Research
- Comprehensive Clinical Research
- Neuro-behavioral Clinical Research
- Midwest Clinical Research Center
- Charak Clinical Research Center
- Oklahoma Clinical Research Center
- Pahl Pharmaceutical Professionals
- CODA
- Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA
- UPenn Treatment Research Center
- Carolina Clinical Trials
- Pillar Clinical Research
- InSite Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
RBP-6000 300mg/100mg
RBP-6000 300mg/300mg
Placebo Matching 300 mg/100 mg RBP-6000
Placebo Matching 300 mg RBP-6000
During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 are separated by 28 days (Day 57-Day 141) and contain RBP-6000 100 mg. In addition, participants received individual drug counseling (IDC) at least once a week.
During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. In addition, participants received individual drug counseling (IDC) at least once a week.
During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given placebo injections on Days 1 and 29 (matching the RBP-6000 300 mg dose volume). Injections 3-6 are separated by 28 days (Day 57-Day 141) and also contain placebo (matching the RBP-6000 100 mg volume). In addition, participants received individual drug counseling (IDC) at least once a week.
During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given six placebo injections (volume-matched to RBP-6000 300 mg dose) on Days 1 to 141 with injections separated by 28 days. In addition, participants received individual drug counseling (IDC) at least once a week.