Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine (OUTLAST-B)

Friends Research Institute

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Opioid-use Disorder

Treatments: Behavioral: Patient Navigation; Drug: Buprenorphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04991974

R01DA045724

Details and patient eligibility

About

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).

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Usual Care (UC)

No Intervention group

Description:

The UC Arm will include standard services from the sexual health clinic / city health department \[at the time of the study, no standardized intervention for opioid use disorder treatment linkage\].

Patient Navigation (PN)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Patient Navigation

Patient Navigation + Buprenorphine Initiation (PN+BUP)

Experimental group

Description:

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.

Treatment:

Drug: Buprenorphine

Behavioral: Patient Navigation