Status:
SUSPENDED
Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder
Lead Sponsor:
Frances R Levin
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study is 12-week, randomized, open-label study comparing injectable extended-release buprenorphine (Sublocade) to standard therapy (sublingual buprenorphine), to see if Sublocade will be more help...
Detailed Description
Outpatients seeking treatment for Opioid Use Disorder (OUD) will be screened, and those eligible and consenting will be randomized (n=40) to either buprenorphine extended-release (BXR, Sublocade) or s...
Eligibility Criteria
Inclusion
- Individuals between the age of 18-65
- Voluntarily seeking treatment for opioid use
- Meets current DSM-5 criteria for Opioid Use Disorder as a primary diagnosis, with at least moderate severity
- Test positive for high potent synthetic opioids (HPSO) use
- Able to provide informed consent and comply with study procedures
Exclusion
- Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
- Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
- Methadone maintenance treatment within the past 30 days
- Buprenorphine maintenance treatment within the past 30 days
- Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients; male participants are required to use adequate forms of birth control as the exposure to sublocade on sperm and subsequent fetal development are not known
- Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure \>150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT \>3 times the upper limit of normal
- Legally mandated to substance use disorder treatment
- Current physiological dependence on alcohol or sedative-hypnotics that would require a medically supervised detoxification-other substance use diagnoses are not exclusionary
- Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g., history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04352166
Start Date
December 15 2020
End Date
June 30 2025
Last Update
February 14 2025
Active Locations (1)
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1
Nyspi-Stars
New York, New York, United States, 10019