Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine



Status:Completed
Conditions:Constipation, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:2/22/2018
Start Date:January 28, 2015
End Date:April 29, 2016

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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess the Efficacy, Safety, and Tolerability of Multiple Subcutaneous Injections of Depot Buprenorphine (RBP-6000 [100 mg and 300 mg]) Over 24 Weeks in Treatment-Seeking Subjects With Opioid Use Disorder

This is a randomized, double-blind, placebo controlled, multicenter study in male and female
participants who are seeking treatment for opioid use disorder.

After completing an up to 2-week screening period, subjects entered an open-label run-in
induction phase with SUBOXONE (buprenorphine/naloxone) sublingual film for 3 days 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.

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.

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
We found this trial at
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New Orleans, Louisiana 70114
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175 Cross Keys Rd.
Berlin, New Jersey 08009
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Charleston, South Carolina 29405
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Dallas, Texas 75243
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DeSoto, Texas 75115
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Fall River, Massachusetts 02720
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Flowood, Mississippi 39232
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Garden Grove, California 92845
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Garfield Heights, Ohio 44125
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Glendale, California 91204
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Haleyville, Alabama 35565
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Hamilton, Alabama 35570
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Jacksonville, Florida 32256
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Lakeland, Florida 33805
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Las Vegas, Nevada 89102
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Lauderhill, Florida 33319
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Little Rock, Arkansas 72211
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Maitland, Florida 32751
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Maitland, Florida 32751
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National City, California 91950
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North Miami, Florida 33161
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Oakland Park, Florida 33334
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73112
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Oklahoma City, Oklahoma 73112
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Philadelphia, Pennsylvania 19104
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Portland, Oregon 97214
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Prairie Village, Kansas 66206
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Saint Louis, Missouri 63141
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San Diego, California 92123
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San Francisco, California 94103
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Schaumburg, Illinois 60194
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Shreveport, Louisiana 71115
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Thousand Oaks, California 91360
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Watertown, Massachusetts
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