NCT04991974

Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Friends Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Patient Navigation	A Patient Navigator will work with participants to facilitate their entry into OUD treatment in the community (e.g., by selecting a program, scheduling intake appointments, and addressing barriers to facilitate successful treatment linkage).
DRUG	Buprenorphine	Buprenorphine is an FDA-approved medication for opioid dependence, and will be used in this study consistent with its approved use (but will be initiated in the novel setting of sexual health clinics in this health services study). Participants will meet with an sexual health clinic provider who holds a waiver to prescribe buprenorphine. Participants will initiate buprenorphine treatment via a home induction under the direction of the provider. Because barriers to transfer may take some time to overcome, participants will be able to receive additional bridge buprenorphine up to two times (up to 15 days' supply at a time) until successful transfer to OUD treatment in the community.

Timeline

• Start date: 2021-09-17
• Primary completion: 2025-07-01
• Completion: 2025-12-31
• First posted: 2021-08-05
• Last updated: 2023-03-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study