Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

NCT04991974 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: R01DA045724
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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).

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• OUD treatment entry (number [%] of participants who enter OUD treatment)

  The primary outcome for the trial is OUD treatment entry by 1 month post-enrollment, defined as admission to a buprenorphine provider (either office-based care or a specialty OUD program), or other licensed OUD treatment program (e.g., methadone, medical detox followed by behavioral treatment).

  1 month

Secondary Outcomes (11)

• OUD treatment retention

  6 months

• Opioid use (self-report)

  6 months

• Opioid use (urine test)

  6 months

• Cocaine use (self-report)

  6 months

• Cocaine use (urine test)

  6 months

Study Arms (3)

Usual Care (UC)

NO INTERVENTION

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

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.

Behavioral: Patient Navigation

Patient Navigation + Buprenorphine Initiation (PN+BUP)

EXPERIMENTAL

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.

Behavioral: Patient Navigation; Drug: Buprenorphine

Interventions

Patient Navigation BEHAVIORAL

A Patient Navigator will work with participants to facilitate their entry into OUD treatment in the community (e.g., by selecting a program, scheduling intake appointments, and addressing barriers to facilitate successful treatment linkage).

Patient Navigation (PN); Patient Navigation + Buprenorphine Initiation (PN+BUP)

Buprenorphine DRUG

Buprenorphine is an FDA-approved medication for opioid dependence, and will be used in this study consistent with its approved use (but will be initiated in the novel setting of sexual health clinics in this health services study). Participants will meet with an sexual health clinic provider who holds a waiver to prescribe buprenorphine. Participants will initiate buprenorphine treatment via a home induction under the direction of the provider. Because barriers to transfer may take some time to overcome, participants will be able to receive additional bridge buprenorphine up to two times (up to 15 days' supply at a time) until successful transfer to OUD treatment in the community.

Also known as: Buprenorphine/naloxone sublingual film

Patient Navigation + Buprenorphine Initiation (PN+BUP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Baltimore City Health Department: collaborator

Study Sites (2)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Baltimore City Health Department Sexual Health Clinics

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

• Nordeck CD, Sharma A, Terplan M, Dusek K, Gilliams E, Gryczynski J. Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine (OUTLAST-B): Rationale, Design, and Evolution of a Randomized Controlled Trial. J Psychiatr Brain Sci. 2023;8(6):e230010. doi: 10.20900/jpbs.20230010. Epub 2023 Dec 25.

  PMID: 38456042 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Patient Navigation; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jan Gryczynski

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: September 17, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Access to de-identified data may be requested after publication of the primary and secondary outcome findings (approximately one year after study completion).
• Access Criteria: 1. Application to Friends Research Institute. 2. Approval of the application and secondary analysis protocol by Friends Research Institute. 3. Execution of a data use agreement between the requesting party and Friends Research Institute. 4. IRB-approval of the proposed secondary research protocol.

Locations

US (2)