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Opioid-use DisorderPhase 2/3OUTLAST-BNCT04991974

Opioid Use Disorder Treatment Linkage at Strategic Touchpoints Using Buprenorphine

A Phase 2/3 study testing Patient Navigation and Buprenorphine in people with Opioid-use Disorder, run by Friends Research Institute, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid-use Disorder
What is being tested?
Patient Navigation and Buprenorphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
373 participants
Where
2 sitesUnited States
Study dates
17 Sep 2021to 31 Jan 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Friends Research Institute

    Baltimore, Maryland, 21201

  • Baltimore City Health Department Sexual Health Clinics

    Baltimore, Maryland, 21202

Other trials in United States

About this study

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).

Read the detailed description

This study, entitled Opioid Use Disorder Treatment Linkage at Strategic Touchpoints using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people with untreated OUD, recruiting from sexual health clinics and through community outreach and referrals. 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 (if applicable), enhanced with brief overdose prevention education (including access to naloxone).

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 a study clinician 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.

Being tested
Patient Navigation, Buprenorphine
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient NavigationBehavioural

    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).

  • BuprenorphineDrug

    Also called Buprenorphine/naloxone sublingual film

    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.

Study groups in NCT04991974
Study groupRoleWhat they receive
Usual Care (UC)No interventionThe UC Arm will include standard services from the sexual health clinic / city health department (if applicable; at the time of the study, no standardized intervention for opioid use disorder treatment linkage), enhanced with brief overdose prevention education (including access to naloxone).
Patient Navigation (PN)Active comparatorThe 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.
Receives: Behavioral: Patient Navigation
Patient Navigation + Buprenorphine Initiation (PN+BUP)ExperimentalThe PN+BUP Arm will include all PN Arm services, with the addition of meeting with a study clinician 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.
Receives: Behavioral: Patient Navigation; Drug: Buprenorphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 month

Secondary outcomes (9)

  1. OUD treatment retention

    Treatment retention will be examined as a secondary outcome and will be determined by self-report, with confirmation of admission/discharge dates through provider records if available.

    Measured: 6 months

  2. Opioid use (self-report)

    Self-reported days of opioid use in the past 30 days

    Measured: 6 months

  3. Opioid use (urine test)

    Opioid urine drug test

    Measured: 6 months

  4. Cocaine use (self-report)

    Self-reported days of cocaine use in the past 30 days

    Measured: 6 months

  5. Cocaine use (urine test)

    Cocaine urine drug test

    Measured: 6 months

  6. OUD diagnostic criteria

    Opioid use disorder diagnostic criteria will be assessed using items from the OUD criteria checklist derived from the modified World Mental Health-Composite International Diagnostic Interview (WMH-CIDI) items that map to the diagnostic criteria. The time frame of the criteria will be modified to past 30 days to capture acute changes.

    Measured: 6 months

  7. Opioid overdose

    Participants will be asked at follow-up about non-fatal opioid overdose experiences. We will obtain medical examiner reports to confirm fatal overdoses.

    Measured: 6 months

  8. Sex Risk Behaviors

    Risky sex behaviors will be gauged by self-report, and include past 90 day frequency of unprotected sex and number of sex partners.

    Measured: 6 months

  9. Drug Risk Behaviors

    Risky drug injection practices in the past 90-days, gauged by self-report

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start17 Sep 2021
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
373 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04991974
Sponsor's protocol ID
R01DA045724
Other IDs
R01DA045724
Acronym
OUTLAST-B
Status last verified
May 2026
First submitted
28 Jul 2021
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We will share de-identified IPD and supporting documentation pending approval of an application and data use agreement with Friends Research Institute

Publications

  • 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.

    PubMed 38456042

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Patient Navigation and Buprenorphine in people with Opioid-use Disorder, run by Friends Research Institute, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OUD treatment entry (number [%] of participants who enter OUD treatment) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04991974, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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