Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
Overview
- Phase
- Phase 2
- Intervention
- Patient Navigation
- Conditions
- Opioid-use Disorder
- Sponsor
- Friends Research Institute, Inc.
- Enrollment
- 360
- Locations
- 2
- Primary Endpoint
- OUD treatment entry (number [%] of participants who enter OUD treatment)
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 or older
- •Opioid use in the past 30 days
- •DSM-5 diagnostic criteria for OUD with physiological dependence
- •Willing to try buprenorphine treatment.
Exclusion Criteria
- •current enrollment in OUD treatment with buprenorphine, methadone, or extended-release naltrexone
- •clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists)
- •regular use of illicit long-acting opioid agonists (e.g., methadone; due to potential challenges with dose induction)
- •heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction
- •high dose or intravenous benzodiazepine misuse
- •pregnancy (due to special needs; will be treated outside of the study)
- •unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation)
- •inability to provide informed consent (e.g., failure to pass consent quiz)
Arms & Interventions
Patient Navigation (PN)
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.
Intervention: Patient Navigation
Patient Navigation + Buprenorphine Initiation (PN+BUP)
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.
Intervention: Patient Navigation
Patient Navigation + Buprenorphine Initiation (PN+BUP)
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.
Intervention: Buprenorphine
Outcomes
Primary Outcomes
OUD treatment entry (number [%] of participants who enter OUD treatment)
Time Frame: 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 Outcomes
- OUD treatment retention(6 months)
- Opioid use (self-report)(6 months)
- Opioid use (urine test)(6 months)
- Cocaine use (self-report)(6 months)
- Cocaine use (urine test)(6 months)
- OUD diagnostic criteria(6 months)
- Opioid overdose(6 months)
- New Diagnoses of HIV/STIs(6 months)
- Adherence to recommended HIV/STI treatment(6 months)
- Sex Risk Behaviors(6 months)
- Drug Risk Behaviors(6 months)