Opioid-use Disorder Clinical Trial
— OUTLAST-BOfficial title:
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
Verified date | March 2023 |
Source | Friends Research Institute, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Enrolling by invitation |
Enrollment | 360 |
Est. completion date | December 31, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 or older 2. Opioid use in the past 30 days 3. DSM-5 diagnostic criteria for OUD with physiological dependence 4. Willing to try buprenorphine treatment. Exclusion Criteria: 1. current enrollment in OUD treatment with buprenorphine, methadone, or extended-release naltrexone 2. clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists) 3. regular use of illicit long-acting opioid agonists (e.g., methadone; due to potential challenges with dose induction) 4. heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction 5. high dose or intravenous benzodiazepine misuse 6. pregnancy (due to special needs; will be treated outside of the study) 7. unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation) 8. inability to provide informed consent (e.g., failure to pass consent quiz) |
Country | Name | City | State |
---|---|---|---|
United States | Baltimore City Health Department Sexual Health Clinics | Baltimore | Maryland |
United States | Friends Research Institute | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Friends Research Institute, Inc. | Baltimore City Health Department, National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OUD treatment entry (number [%] of participants who enter OUD treatment) | The primary outcome for the trial is OUD treatment entry by 1 month post-enrollment, defined as admission to a buprenorphine provider (either office-based care or a specialty OUD program), or other licensed OUD treatment program (e.g., methadone, medical detox followed by behavioral treatment). | 1 month | |
Secondary | OUD treatment retention | Treatment retention will be examined as a secondary outcome and will be determined by self-report, with confirmation of admission/discharge dates through provider records if available. | 6 months | |
Secondary | Opioid use (self-report) | Self-reported days of opioid use in the past 30 days | 6 months | |
Secondary | Opioid use (urine test) | Opioid urine drug test | 6 months | |
Secondary | Cocaine use (self-report) | Self-reported days of cocaine use in the past 30 days | 6 months | |
Secondary | Cocaine use (urine test) | Cocaine urine drug test | 6 months | |
Secondary | OUD diagnostic criteria | Opioid use disorder diagnostic criteria will be assessed using items from the OUD criteria checklist derived from the modified World Mental Health-Composite International Diagnostic Interview (WMH-CIDI) items that map to the diagnostic criteria. The time frame of the criteria will be modified to past 30 days to capture acute changes. | 6 months | |
Secondary | Opioid overdose | Participants will be asked at follow-up about non-fatal opioid overdose experiences. We will obtain medical examiner reports to confirm fatal overdoses. | 6 months | |
Secondary | New Diagnoses of HIV/STIs | New diagnoses of HIV and sexually transmitted infections will be determined via self-report and health department records. | 6 months | |
Secondary | Adherence to recommended HIV/STI treatment | Participants will be asked at follow-up whether they took as directed their specific HIV/STI medications, including (if applicable) any extended antibiotics for bacterial STDs, antiretroviral therapy for HIV+ participants, and PrEP to safeguard against acquiring HIV. | 6 months | |
Secondary | Sex Risk Behaviors | Risky sex behaviors will be gauged by self-report, and include past 90 day frequency of unprotected sex and number of sex partners. | 6 months | |
Secondary | Drug Risk Behaviors | Risky drug injection practices in the past 90-days, gauged by self-report | 6 months |
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