Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
NCT ID: NCT02357901
Last Updated: 2018-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
665 participants
INTERVENTIONAL
2015-01-28
2016-04-29
Brief Summary
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Detailed Description
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This is a 24-week non-residential study with participants being randomized after meeting randomization criteria. On Day 1 and Day 29 (± 2 days) participants will receive subcutaneous injections of 300 mg RBP-6000 or placebo. Thereafter, participants will receive 4 injections (once every 28 days ± 2 days) of either 300 mg or 100 mg RBP-6000 doses or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RBP-6000 300mg/100mg
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.
SUBOXONE
SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
RBP-6000
Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.
RBP-6000 300mg/300mg
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.
SUBOXONE
SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
RBP-6000
Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.
Placebo Matching 300 mg/100 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 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.
SUBOXONE
SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
Placebo
Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
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 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.
SUBOXONE
SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
Placebo
Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
Interventions
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SUBOXONE
SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
RBP-6000
Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.
Placebo
Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Director Global Clinical Development
Role: STUDY_DIRECTOR
Indivior Inc.
Locations
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Haleyville Clinical Research
Haleyville, Alabama, United States
Boyett Health Services
Hamilton, Alabama, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
Behavioral Research Specialists
Glendale, California, United States
Synergy Clinical Research Center
National City, California, United States
North County Clinical Research
Oceanside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Care Practice
San Francisco, California, United States
Southern California Research
Thousand Oaks, California, United States
Amit Vijapura
Jacksonville, Florida, United States
Meridien Research
Lakeland, Florida, United States
Innovative Clinical Research
Lauderhill, Florida, United States
Florida Clinical Research Center
Maitland, Florida, United States
Try Research
Maitland, Florida, United States
Scientific Clinical Research
North Miami, Florida, United States
Research Centers of America
Oakland Park, Florida, United States
Behavioral Health Care Associates
Schaumburg, Illinois, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
Louisiana Clinical Research
Shreveport, Louisiana, United States
Stanley Street Treatment and Resources
Fall River, Massachusetts, United States
Adams Clinical Trials
Watertown, Massachusetts, United States
Precise Research Centers, Inc.
Flowood, Mississippi, United States
St Louis Clinical Trials
St Louis, Missouri, United States
Altea Research
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Neuro-behavioral Clinical Research
Canton, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Charak Clinical Research Center
Garfield Heights, Ohio, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States
Pahl Pharmaceutical Professionals
Oklahoma City, Oklahoma, United States
CODA
Portland, Oregon, United States
Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA
Altoona, Pennsylvania, United States
UPenn Treatment Research Center
Philadelphia, Pennsylvania, United States
Carolina Clinical Trials
Charleston, South Carolina, United States
Pillar Clinical Research
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Countries
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References
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Greenwald MK, Wiest KL, Haight BR, Laffont CM, Zhao Y. Examining the benefit of a higher maintenance dose of extended-release buprenorphine in opioid-injecting participants treated for opioid use disorder. Harm Reduct J. 2023 Dec 2;20(1):173. doi: 10.1186/s12954-023-00906-7.
Rutrick D, Learned SM, Boyett B, Hassman D, Shinde S, Zhao Y. 18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. J Subst Use Addict Treat. 2023 Nov;154:209155. doi: 10.1016/j.josat.2023.209155. Epub 2023 Aug 30.
Laffont CM, Ngaimisi E, Gopalakrishnan M, Ivaturi V, Young M, Greenwald MK, Heidbreder C. Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder. Front Pharmacol. 2022 Nov 18;13:1052113. doi: 10.3389/fphar.2022.1052113. eCollection 2022.
Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.
Boyett B, Wiest K, McLeod LD, Nelson LM, Bickel WK, Learned SM, Heidbreder C, Fudala PJ, Le Moigne A, Zhao Y. Assessment of craving in opioid use disorder: Psychometric evaluation and predictive validity of the opioid craving VAS. Drug Alcohol Depend. 2021 Dec 1;229(Pt B):109057. doi: 10.1016/j.drugalcdep.2021.109057. Epub 2021 Sep 24.
Kranzler HR, Lynch KG, Crist RC, Hartwell E, Le Moigne A, Laffont CM, Andorn AC. A Delta-Opioid Receptor Gene Polymorphism Moderates the Therapeutic Response to Extended-Release Buprenorphine in Opioid Use Disorder. Int J Neuropsychopharmacol. 2021 Feb 15;24(2):89-96. doi: 10.1093/ijnp/pyaa069.
Haight BR, Learned SM, Laffont CM, Fudala PJ, Zhao Y, Garofalo AS, Greenwald MK, Nadipelli VR, Ling W, Heidbreder C; RB-US-13-0001 Study Investigators. Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2019 Feb 23;393(10173):778-790. doi: 10.1016/S0140-6736(18)32259-1. Epub 2019 Feb 18.
Other Identifiers
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RB-US-13-0001
Identifier Type: -
Identifier Source: org_study_id
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