Buprenorphine + Patient Navigation for Opioid Use Disorder
(OUTLAST-B Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will examine the effectiveness of opioid use disorder (OUD) treatment linkage strategies for patients seen at sexual health clinics. This 3-arm RCT will compare Usual Care vs. Patient Navigation vs. Patient Navigation + Buprenorphine Initiation (UC vs. PN vs. PN+BUP).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently on buprenorphine, methadone, or extended-release naltrexone for opioid use disorder, you cannot participate in this study.
Is buprenorphine safe for humans?
How is the drug Buprenorphine unique for treating opioid use disorder?
What data supports the effectiveness of the drug Buprenorphine for treating opioid use disorder?
Who Is on the Research Team?
Jan Gryczynski, MD
Principal Investigator
Friends Research Institute, Inc.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with opioid use disorder who have used opioids in the last month and are willing to try buprenorphine treatment. It's not for those misusing benzodiazepines, pregnant women, people with unstable health conditions or heavy alcohol users, anyone already in OUD treatment, or unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to one of three arms: Usual Care, Patient Navigation, or Patient Navigation + Buprenorphine Initiation. Treatment includes standard services, patient navigation, and/or buprenorphine initiation.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 3 months, and 6 months.
Long-term follow-up
Selected outcomes will be examined through 12 months via health record linkage methods.
What Are the Treatments Tested in This Trial?
Interventions
- Buprenorphine
- Patient Navigation
Buprenorphine is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Friends Research Institute, Inc.
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Baltimore City Health Department
Collaborator