Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

Phase 2

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Patient Navigation; Drug: Buprenorphine

• Registration Number: NCT04991974
• Lead Sponsor: Friends Research Institute, Inc.

Brief Summary

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).

Detailed Description

This study, entitled Opioid Use Disorder Treatment Linkage at Sexual Health Clinics using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people receiving sexual health services from public clinics and health departments. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with buprenorphine initiation (PN+BUP).

The UC Arm will include standard services at the sexual health clinic / city health department.

The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment.

The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the sexual health clinic's buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community.

Research assessments consisting of a structured interview battery and biomarkers for drug use and sexually transmitted infections will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Study Start: 2021-09-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 360

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation (PN)	Patient Navigation	The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment.
Patient Navigation + Buprenorphine Initiation (PN+BUP)	Patient Navigation	The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the sexual health clinic's buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. The standard buprenorphine bridge prescription will be for buprenorphine/naloxone film: 8/2mg, up to 16mg per day, 7 day supply.
Patient Navigation + Buprenorphine Initiation (PN+BUP)	Buprenorphine	The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the sexual health clinic's buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. The standard buprenorphine bridge prescription will be for buprenorphine/naloxone film: 8/2mg, up to 16mg per day, 7 day supply.

Primary Outcome Measures

Name	Time	Method
OUD treatment entry (number [%] of participants who enter OUD treatment)	1 month	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).

Secondary Outcome Measures

Name	Time	Method
OUD treatment retention	6 months	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.
Opioid use (self-report)	6 months	Self-reported days of opioid use in the past 30 days
Opioid use (urine test)	6 months	Opioid urine drug test
Cocaine use (self-report)	6 months	Self-reported days of cocaine use in the past 30 days
Cocaine use (urine test)	6 months	Cocaine urine drug test
OUD diagnostic criteria	6 months	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.
Opioid overdose	6 months	Participants will be asked at follow-up about non-fatal opioid overdose experiences. We will obtain medical examiner reports to confirm fatal overdoses.
New Diagnoses of HIV/STIs	6 months	New diagnoses of HIV and sexually transmitted infections will be determined via self-report and health department records.
Adherence to recommended HIV/STI treatment	6 months	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.
Sex Risk Behaviors	6 months	Risky sex behaviors will be gauged by self-report, and include past 90 day frequency of unprotected sex and number of sex partners.
Drug Risk Behaviors	6 months	Risky drug injection practices in the past 90-days, gauged by self-report

Trial Locations

Locations (2)

Baltimore City Health Department Sexual Health Clinics; 🇺🇸 Baltimore, Maryland, United States

Friends Research Institute; 🇺🇸 Baltimore, Maryland, United States