Opioid Use DisorderNCT06416020
Integrating MOUD in Nonmedical Community Settings (Better Together)
A study testing HC-MOUD Only and BT-MOUD with Buprenorphine in people with Opioid Use Disorder, run by Howard University at 4 sites in United States.
Trial summary
A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- HC-MOUD Only and BT-MOUD with Buprenorphine
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Apr 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be 16 years of age or older
- Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 90 days before the day of randomization or on the day of randomization. [Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.]
- Is willing and able to provide written informed consent
- Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments
- Speaks English well enough to be able to comprehend the study procedures and complete the assessments
Who cannot join
- In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has been covered by MOUD (oral, sublingual, injection) as an outpatient for more than 10 consecutive days. [Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.]
- Plans to move out of the area or anticipate not being able to remain in the study for 6 months
- Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
- Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Maryland
Baltimore, Maryland, 21223
Eric Weintraub, MD, 410-328-7919, eweintra@som.umaryland.edu
Heather Fitzsimons, MPH, 443-462-3400, hfitzsimons@som.umaryland.edu
- Recruiting
University of Illinois- Chicago
Chicago, Illinois, 60608
Niranjan Karnik, MD, PhD, 312-273-0185
Konadu Fokuo, PhD, 312-413-8357, jkfoko@uic.edu
- Recruiting
University of Miami
Miami, Florida, 33136
Viviana Horigian, MD, MHA, vhorigian@med.miami.edu
Bijan Lochart-Rodriquez, MBA, 636-387-8154, bxl@med.miami.edu
- Recruiting
Howard University
Washington D.C., District of Columbia, 20059
Richard S Schottenfeld, MD, 202-865-6615, richard.schottenfeld@howard.edu
Denise M Scott, PhD, 202-806-5264 ext. Scott, d_m_scott@howard.edu
About this study
A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.
Read the detailed description
This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, Miami-Dade County and Baltimore will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining persons with OUD in MOUD with buprenorphine through six months post-randomization.
- Conditions
- Opioid Use Disorder
- Being tested
- HC-MOUD Only, BT-MOUD with Buprenorphine
- Keywords
- MOUD, OUD, 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.
HC-MOUD OnlyBehavioural
Also called Hub Clinic MOUD with Buprenorphine
MOUD with buprenorphine provided in a hub buprenorphine clinic
BT-MOUD with BuprenorphineBehavioural
Also called Better Together MOUD with Buprenorphine
MOUD with buprenorphine provided by a hub buprenorphine provider either in the hub clinic or via telemedicine at a community hub; Recovery Guiding provided to participants
| Study group | Role | What they receive |
|---|---|---|
| Hub Clinic MOUD with buprenorphine only (HC-MOUD Only) | Active comparator | Participants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic. Receives: Behavioral: HC-MOUD Only |
| Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures | Experimental | Better Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment. Receives: Behavioral: BT-MOUD with Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buprenorphine MOUD Treatment Retention
Duration of continuous participation in the hub clinic provided buprenorphine treatment
Measured: 0-168 days
Secondary outcomes (7)
Self-reported adherence to MOUD with buprenorphine
Number of days self-reported adherence to MOUD with buprenorphine assessed using timeline follow back (TLFB) Adherence to buprenorphine during the 168-day study period
Measured: 0-168 days
Self-reported nonmedical opioid use
Number of days self-reported days of nonmedical opioid use, stimulant use, benzodiazepine use during the 168 study period
Measured: 0-168 days
Self-reported nonmedical other drug use
Number of days self-reported other drug use
Measured: 0-168 days
Urine Toxicology
Number of opioid-negative urine toxicology tests, ranging from 0 to 6.
Measured: Months 1,2 3,4,5,6
Health-related quality of life (HRQOL)
Assess quality of life using the Health-related Quality of Life Health Related Quality of Life -4: Scores range from 1-5 for Q1, assessing overall health-related quality of life, and from 0-30 for Q2, Q3, and Q4 assessing physical health (Q2), mental health (Q3), and interference from health or mental health problems (Q4); higher scores indicate worse outcomes.
Measured: Months 1,2 3,4,5,6
Patient Health Questionnaire Depression Scale
Assess depressive symptoms using Patient Health Questionnaire Depression Scale-8 (PHQ-8). Scores range from 0 to 24. Higher scores are indicators of greater depression severity.
Measured: Months 1,2,3,4,5,6
Pharmacy Dispensed Buprenorphine
Data regarding HUB clinic prescribed buprenorphine that is dispensed to the participant by a pharmacy will be obtained as part of the abstraction of data from electronic medical and pharmacy records.
Measured: Months 1, 2, 3, 4, 5, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 Apr 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multisite hybrid Type 1 effectiveness-implementation randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, University of Miami, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of Maryland
- Responsible party
- Principal investigator, Richard Schottenfeld, Howard University
- Investigators
- Richard S Schottenfeld, MD, Principal investigator, Howard UniversityViviana Horigian, MD, MHA, Principal investigator, University of MiamiNiranjan Karnik, MD, PhD, Principal investigator, University of Illinois ChicagoDenise M. Scott, PhD, Study director, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416020
- Sponsor's protocol ID
- NIDA CTN Protocol 0144
- Other IDs
- UG1DA013720
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Policy for Data Management and Sharing (Notice Number: NOT-OD-21-013) (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and for Helping to End Addiction Long-Term (HEAL) funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal initiative/research/heal public-access-data-sharing-policy)\]. For more details on data sharing please visit https://datashare.nida.nih.gov/.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating MOUD in Nonmedical Community Settings (Better Together)
- ClinicalTrials.gov ID
- NCT06416020
- Acronym / sponsor ID
- NIDA CTN Protocol 0144
- Conditions
- Opioid Use Disorder
- Keywords
- MOUD, OUD, Buprenorphine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, University of Miami, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC, University of Maryland
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multisite effectiveness-implementation study will be conducted in four sites to evaluate interventions to improve engagement and retention in MOUD with buprenorphine treatment persons with Opioid Use Disorder (OUD) in urban neighborhoods with high overdose rates. The investigators hypothesize that treatment with the Better Together Integrated Collaborative Community MOUD care model (BT-MOUD) will result in better retention in treatment than standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) through 24 weeks following randomization. BT-MOUD provides MOUD with buprenorphine in nonmedical community-based settings via telemedicine from a hub buprenorphine clinic combined with Recovery Guiding, a manual guided coaching developed for this approach, provided onsite in the community organization.
Detailed description
This multi-site hybrid Type 1 effectiveness-implementation study conducted in Washington, District of Columbia (DC), Chicago, Miami-Dade County and Baltimore will evaluate: 1) the effectiveness of providing MOUD with buprenorphine onsite (via telemedicine from a hub buprenorphine clinic) combined with Recovery Guiding in nonmedical community-based settings (the Better Together Integrated Collaborative Community MOUD care model - BT-MOUD) compared to standard-of-care MOUD with buprenorphine provided in the hub buprenorphine clinic only (HC-MOUD Only) and 2) BT-MOUD implementation barriers and facilitators. In the BT-MOUD intervention, community sites serve as "spokes" for telemedicine provision of MOUD by buprenorphine providers based in a "hub" buprenorphine clinic. A trained and supervised Recovery Guide with roots or connections with the community provides manual-guided Recovery Guiding on-site in the community site. Recovery Guiding includes psychoeducation (about OUD and effective buprenorphine MOUD) and behavioral counseling to promote engagement in MOUD with buprenorphine, retention in care, medication adherence, and behavioral change supportive of recovery. In HC-MOUD Only, participants will receive MOUD with buprenorphine and other available services in the hub buprenorphine clinic only. A Peer Outreach Specialist (POS) will assist with outreach and recruitment of all participants across conditions and with maintaining high rates of follow-up in research assessments. This study will test the hypothesis that BT-MOUD is more effective than HC-MOUD Only in retaining persons with OUD in MOUD with buprenorphine through six months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multisite hybrid Type 1 effectiveness-implementation randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hub Clinic MOUD with buprenorphine only (HC-MOUD Only) | Active comparator | Behavioral: HC-MOUD OnlyParticipants will receive MOUD with buprenorphine prescribed by providers based at participating hub clinics. MOUD treatment with buprenorphine will follow standard guidelines for induction and maintenance using a sublingual buprenorphine formulation. Hub clinic buprenorphine providers and participants may shift to long acting injection buprenorphine formulations after initial induction with sublingual buprenorphine. If telemedicine prescribing of MOUD with buprenorphine is part of the usual standard of care at the clinic, participants assigned to HC-MOUD Only may be prescribed buprenorphine via telemedicine, following the clinic's usual guidelines. Participants may not receive telemedicine services at the community spokes or Recovery Guiding, which are available only to participants assigned to BTMOUD. All study participants, however, may have access to any services that are routinely provided as part of the MOUD with buprenorphine treatment-as-usual care in the hub clinic. |
| Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures | Experimental | Behavioral: BT-MOUD with BuprenorphineBetter Together Medications for Opioid Use Disorder (BT-MOUD) includes HC-MOUD plus access to telemedicine provision of MOUD with buprenorphine at a nonmedical community organization spoke, plus manual-guided Recovery Guiding provided onsite at the spoke, and plus any other services available at the community organization spoke. Recovery Guiding is a manualized, highly structured, stepwise intervention that uses educational and behavioral tools to provide pragmatic guidance for patients beginning buprenorphine treatment and to address the key recovery misconceptions and dysfunctional behaviors that frequently interfere with recovery efforts of patients initiating medication for opioid use disorder (MOUD) treatment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Be 16 years of age or older
- Has been newly prescribed MOUD with buprenorphine by a hub clinic provider no more than 90 days before the day of randomization or on the day of randomization. [Note that the "start" of a "current, new treatment episode" of MOUD with buprenorphine is defined as the date MOUD with buprenorphine was prescribed by a hub clinic provider.]
- Is willing and able to provide written informed consent
- Is willing and able to provide reliable locator information to facilitate contacting the participant for research follow-up assessments
- Speaks English well enough to be able to comprehend the study procedures and complete the assessments
Key exclusion criteria (4 listed)
- In the 30 days prior to receiving the prescription for MOUD with buprenorphine from the hub clinic provider, has been covered by MOUD (oral, sublingual, injection) as an outpatient for more than 10 consecutive days. [Note that receipt of MOUD in a hospital, residential treatment, or carceral setting would not trigger exclusion.]
- Plans to move out of the area or anticipate not being able to remain in the study for 6 months
- Is currently in jail, prison, or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
- Has been previously enrolled in CTN-0144 or CTN-0088 or is currently enrolled in another clinical trial for treatment of OUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC-MOUD OnlyAlso: Hub Clinic MOUD with BuprenorphineMOUD with buprenorphine provided in a hub buprenorphine clinic | Behavioural | Hub Clinic MOUD with buprenorphine only (HC-MOUD Only) |
| BT-MOUD with BuprenorphineAlso: Better Together MOUD with BuprenorphineMOUD with buprenorphine provided by a hub buprenorphine provider either in the hub clinic or via telemedicine at a community hub; Recovery Guiding provided to participants | Behavioural | Recovery Guiding / Better Together Medications for Opioid Use Disorder (BT-MOUD) procedures |
Primary outcome
Buprenorphine MOUD Treatment Retention
Time frame: 0-168 days
Duration of continuous participation in the hub clinic provided buprenorphine treatment
7 secondary outcomes
Self-reported adherence to MOUD with buprenorphine
Time frame: 0-168 days
Self-reported nonmedical opioid use
Time frame: 0-168 days
Self-reported nonmedical other drug use
Time frame: 0-168 days
Urine Toxicology
Time frame: Months 1,2 3,4,5,6
Health-related quality of life (HRQOL)
Time frame: Months 1,2 3,4,5,6
Patient Health Questionnaire Depression Scale
Time frame: Months 1,2,3,4,5,6
Pharmacy Dispensed Buprenorphine
Time frame: Months 1, 2, 3, 4, 5, 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Policy for Data Management and Sharing (Notice Number: NOT-OD-21-013) (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and for Helping to End Addiction Long-Term (HEAL) funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal initiative/research/heal public-access-data-sharing-policy)]. For more details on data sharing please visit https://datashare.nida.nih.gov/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard S Schottenfeld, MD principal investigator
Howard University
Viviana Horigian, MD, MHA principal investigator
University of Miami
Niranjan Karnik, MD, PhD principal investigator
University of Illinois Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HC-MOUD Only and BT-MOUD with Buprenorphine in people with Opioid Use Disorder, run by Howard University at 4 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard S Schottenfeld, MD (202-865-6615, richard.schottenfeld@howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buprenorphine MOUD Treatment Retention (time frame: 0-168 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.