Clinical trial NCT04991974: Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
Official title: Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Opioid-use Disorder
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Baltimore City Health Department
First posted: 2021-08-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: OUD treatment entry (number [%] of participants who enter OUD treatment)
timeFrame: 1 month
Secondary outcomes:
measure: OUD treatment retention
timeFrame: 6 months
measure: Opioid use (self-report)
timeFrame: 6 months
measure: Opioid use (urine test)
timeFrame: 6 months
measure: Cocaine use (self-report)
timeFrame: 6 months
measure: Cocaine use (urine test)
timeFrame: 6 months
measure: OUD diagnostic criteria
timeFrame: 6 months
measure: Opioid overdose
timeFrame: 6 months
measure: New Diagnoses of HIV/STIs
timeFrame: 6 months
measure: Adherence to recommended HIV/STI treatment
timeFrame: 6 months
measure: Sex Risk Behaviors
timeFrame: 6 months
measure: Drug Risk Behaviors
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Baltimore City Health Department Sexual Health Clinics
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Jan Gryczynski
role: PRINCIPAL_INVESTIGATOR
References: