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 |
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.
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.
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
38
sites
Altoona, Pennsylvania 16602
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