Opioid Use Disorder - Garden Grove CA (Metro Los Angeles)

Summary:

A Randomised, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection in Treatment-Seeking Adult Participants with Opioid Use Disorder and High-risk Opioid Use. The first primary efficacy endpoint is the proportion of responders for weekly opioid use, where a responder is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 10 to 38.

Inclusion Criteria:

1. Has signed the informed consent form (ICF) and is able and willing to comply with the requirements and restrictions listed therein.
2. Is 18 years of age or older at the time of signing the ICF.
3. Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD).
4. Has a history of OUD as defined by documented medical history of OUD for at least 90 days immediately prior to providing informed consent.

5. Meets at least 1 of these criteria for high-risk opioid use at the Screening visit:

   1. using opioids via the injection route for an average of 5 or more days per week in the last 4 weeks.
   2. using at least 500 mg IV heroin equivalent (e.g., 1250 mg intravenous (IV) morphine) or self-reported use of any dose of highly potent synthetic opioids (fentanyl and analogues excluding transdermal patches) for an average of 5 or more days per week in the last 4 weeks by any route.
6. Is seeking medication for the treatment of OUD.
7. Is an appropriate candidate for opioid partial-agonist medications for opioid use disorder (MOUD) in the opinion of the Investigator or medically qualified sub-Investigator.
8. Agrees not to use buprenorphine-containing products other than those administered as part of study treatment for the duration of the treatment period.
9. A female participant is eligible to participate if she is not pregnant, not lactating and, if of childbearing potential, agrees not to become pregnant while on the study and to use medically acceptable means of contraception while on the study).

Qualified Participants May Receive:

Compensation for participation in research.