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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

OUTLAST-B Trial 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.Check my eligibility
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.See study design
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.

OUTLAST-B Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

OUTLAST-B Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OUD treatment entry (number [%] of participants who enter OUD treatment)
Secondary outcome measures
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
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
OL Buprenorphine HCl Buccal Film
DB Buprenorphine HCl Buccal Film
DB Placebo Film

OUTLAST-B 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
Buprenorphine
2014
Completed Phase 4
~2600
Patient Navigation
2017
Completed Phase 2
~38910

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,487 Previous Clinical Trials
2,622,271 Total Patients Enrolled
Friends Research Institute, Inc.Lead Sponsor
53 Previous Clinical Trials
20,443 Total Patients Enrolled
Baltimore City Health DepartmentOTHER
7 Previous Clinical Trials
18,640 Total Patients Enrolled

Media Library

Buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04991974 — Phase 2 & 3
Opioid Use Disorder Research Study Groups: Patient Navigation (PN), Usual Care (UC), Patient Navigation + Buprenorphine Initiation (PN+BUP)
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT04991974 — Phase 2 & 3
Buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04991974 — Phase 2 & 3
~96 spots leftby Jul 2025
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