Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine

This study, entitled Opioid Use Disorder Treatment Linkage at Strategic Touchpoints using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people with untreated OUD, recruiting from sexual health clinics and through community outreach and referrals. 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 (if applicable), enhanced with brief overdose prevention education (including access to naloxone).

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 a study clinician 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.

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)