Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine

Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine

This study will examine the effectiveness of opioid use disorder (OUD) treatment linkage strategies for patients identified at sexual health clinics and through community outreach and referrals. This 3-arm RCT will compare Usual Care vs. Patient Navigation vs. Patient Navigation + Buprenorphine Initiation (UC vs. PN vs. PN+BUP).

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:

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)