Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine
Completed · Phase 2/Phase 3
Conditions studied: Opioid-use Disorder
In brief
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).
Key facts
- Study ID
- NCT04991974
- Run by
- Friends Research Institute, Inc.
- People needed
- 373
- Starts
- 2021-09-17
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2026-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Friends Research Institute — Baltimore, Maryland, United States
- Baltimore City Health Department Sexual Health Clinics — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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