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Opioid Partial Agonist

Buprenorphine + Patient Navigation for Opioid Use Disorder (OUTLAST-B Trial)

Phase 2 & 3

Waitlist Available

Led By Jan Gryczynski

Research Sponsored by Friends Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Be older than 18 years old

Must not have

Unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation)

Clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare different ways of helping people with opioid addiction get treatment, to see which is most effective.

Who is the study for?

This trial is for adults over 18 with opioid use disorder who have used opioids in the last month and are willing to try buprenorphine treatment. It's not for those misusing benzodiazepines, pregnant women, people with unstable health conditions or heavy alcohol users, anyone already in OUD treatment, or unable to consent.

What is being tested?

The study compares three strategies at sexual health clinics: usual care; patient navigation (PN); and PN plus immediate start of buprenorphine (PN+BUP). The goal is to see which method best helps patients link to opioid use disorder treatments.

What are the potential side effects?

Buprenorphine may cause side effects like nausea, drowsiness, constipation, headache, or sweating. Patient Navigation itself doesn't involve medication so it has no direct medical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable medical or mental health conditions.

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I am allergic to buprenorphine or naloxone, or I am on chronic opioid pain medication.

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I regularly use long-acting opioids like methadone.

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I understand the details of the clinical trial and can give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Adherence to recommended HIV/STI treatment

Cocaine use (self-report)

Cocaine use (urine test)

+8 more

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167

17%

Nausea

Constipation

Vomiting

Headache

Dizziness

Somnolence

Drug withdrawal syndrome

100%

80%

60%

40%

20%

Study treatment Arm

OL Buprenorphine HCl Buccal Film

DB Buprenorphine HCl Buccal Film

DB Placebo Film

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Patient Navigation + Buprenorphine Initiation (PN+BUP)Experimental Treatment2 Interventions

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.

Group II: Patient Navigation (PN)Active Control1 Intervention

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.

Group III: Usual Care (UC)Active Control1 Intervention

The UC Arm will include standard services from the sexual health clinic / city health department \[at the time of the study, no standardized intervention for opioid use disorder treatment linkage\].

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

Buprenorphine

2014

Completed Phase 4

~2600