Drug Use DisordersABC-SUDNCT06729957
Addressing Barriers to Care for Substance Use Disorder Trial
A study testing Care Navigation in people with Drug Use Disorders and Alcohol-Related Disorders, run by Kaiser Permanente at 1 site in United States.
Trial summary
The Addressing Barriers to Care for Substance Use Disorder Trial (ABC-SUD) is a cluster-randomized crossover trial, with clinicians (care coordinators) as the unit of randomization. This study will be conducted in a mental health access center within the Washington region of Kaiser Permanente. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use Disorders, Alcohol-Related Disorders, Substance Use Disorder (SUD)
- What is being tested?
- Care Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 21 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinician (Care Coordinator) Inclusion Criteria:
- Conducts assessment and treatment planning visits in the mental health access center
- Has been employed for at least 1 month
- Has completed trainings related to their clinical role in the health system
- Scheduled to conduct assessments
Clinician Exclusion Criteria: None
Patient Inclusion Criteria (eligibility for analyses):
- Visits an enrolled care coordinator during the patient eligibility period
- ≥ 18 years of age at the time of the visit
- Has an assessment and treatment planning visit for SUD with an enrolled care coordinator
Patient Exclusion Criteria:
- Patients who have requested through the health system to opt out of research contact or chart review
- Patients who are not enrolled in Kaiser Permanente insurance, or those only enrolled in Medicaid (anticipated incomplete capture of covariate and/or outcome information)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington
Seattle, Washington, 98101
About this study
Official title: Addressing Barriers to Care for Substance Use Disorder Trial (Center for Dissemination and Implementation At Stanford, Research Component #3)
The Addressing Barriers to Care for Substance Use Disorder Trial (ABC-SUD) is a cluster-randomized crossover trial, with clinicians (care coordinators) as the unit of randomization.
This study will be conducted in a mental health access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a care coordinator to obtain an appointment with or contact information for potential venues to obtain treatment for substance use disorder.
The experimental intervention, Care Navigation, will be evaluated for its potential to increase engagement in substance use disorder treatment among patients who contact the mental health access center. Care Navigation will be delivered by study care navigators, who are distinct from the health system's care coordinators.
Read the detailed description
The ABC-SUD Trial is a cluster-randomized crossover trial evaluating the effectiveness of care navigation in increasing engagement in substance use disorder treatment. Each care coordinator is randomly assigned to a study arm (services as usual or care navigation) at the beginning of the trial (period 1), and halfway through the trial, switches to the other study arm (period 2). The patient population includes individuals who are seeking substance use treatment and are evaluated by enrolled care coordinators.
During periods in which care coordinators are assigned to the intervention arm, care coordinators offer care navigation to patients and utilize an electronic health record referral tool to refer patients to care navigators. This tool is disabled for care coordinators during the period in which they are assigned to the control arm.
This study will employ an encouragement design, where patients who speak with intervention care coordinators are offered care navigation, but patients choose whether to participate in care navigation. Primary analyses will follow an intent-to-treat principle whereby care coordinators and patients will be analyzed according to the intervention arm to which they are assigned regardless of the subsequent sequence of events.
- Being tested
- Care Navigation
- Keywords
- Implementation Science, Care Navigation, Drug Use Disorders, Quality Improvement, Behavioral Health
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care NavigationBehavioural
Care navigation is an intervention that seeks to help patients engage in substance use treatment by increasing motivation and reducing barriers to accessing treatment. The care navigator helps the patient engage in the treatment plan established by the mental health care coordinator.
| Study group | Role | What they receive |
|---|---|---|
| Care Navigation | Experimental | Mental health care coordinators are able to offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual. Receives: Behavioral: Care Navigation |
| Services as Usual | No intervention | Mental health care coordinators will continue offering substance use resources and treatment options to patients as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in treatment for substance use disorder
Completion of ≥ 3 treatment visits for substance use disorder within 48 days of their assessment visit
Measured: 48 days
Secondary outcomes (1)
Initiation of treatment for substance use disorder
Completion of ≥ 1 treatment visit for substance use disorder within 30 days of their assessment visit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start16 Dec 2024
- Primary completion21 Aug 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Use DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Care coordinators will be randomized to care navigation arm or services as usual arm at study outset and switch to the opposite arm halfway through the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Stanford University
- Responsible party
- Principal investigator, Joseph Glass, Chestnut Health Systems
- Investigators
- Joseph E Glass, PhD, MSW, Principal investigator, Chestnut Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729957
- Sponsor's protocol ID
- 2068557T
- Other IDs
- P50DA054072
- Acronym
- ABC-SUD
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study protocol is embedded within a Center of Excellence funded by the National Institute on Drug Abuse. In coordination with other center project components, the study protocol will be submitted for publication to either an addiction or implementation science journal. Additional data (analytic code) can be requested from the Principal Investigator. Participant data will be shared with the prime site as allowed. Analysis files will be constructed from the electronic data and aggregated. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the aggregated files.
Publications
Matson TE, Navarro MA, Idu A, Bobb JF, Patrick BM, Phillips R, Barrett TD, Rossi FS, Krawczyk N, Doud R, Rogers K, Davis CJ, Caldeiro R, Glass JE. Design of a cluster-randomized, hybrid type 1 effectiveness-implementation trial of a care navigation intervention to increase substance use disorder treatment engagement: study protocol. Addict Sci Clin Pract. 2025 Oct 1;20(1):78. doi: 10.1186/s13722-025-00605-7.
PubMed 41035041
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Barriers to Care for Substance Use Disorder Trial (Center for Dissemination and Implementation At Stanford, Research Component #3)
- ClinicalTrials.gov ID
- NCT06729957
- Acronym / sponsor ID
- ABC-SUD / 2068557T
- Keywords
- Implementation Science, Care Navigation, Drug Use Disorders, Quality Improvement, Behavioral Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Stanford University
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 12 Dec 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.
The Addressing Barriers to Care for Substance Use Disorder Trial (ABC-SUD) is a cluster-randomized crossover trial, with clinicians (care coordinators) as the unit of randomization.
This study will be conducted in a mental health access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a care coordinator to obtain an appointment with or contact information for potential venues to obtain treatment for substance use disorder.
The experimental intervention, Care Navigation, will be evaluated for its potential to increase engagement in substance use disorder treatment among patients who contact the mental health access center. Care Navigation will be delivered by study care navigators, who are distinct from the health system's care coordinators.
Detailed description
The ABC-SUD Trial is a cluster-randomized crossover trial evaluating the effectiveness of care navigation in increasing engagement in substance use disorder treatment. Each care coordinator is randomly assigned to a study arm (services as usual or care navigation) at the beginning of the trial (period 1), and halfway through the trial, switches to the other study arm (period 2). The patient population includes individuals who are seeking substance use treatment and are evaluated by enrolled care coordinators.
During periods in which care coordinators are assigned to the intervention arm, care coordinators offer care navigation to patients and utilize an electronic health record referral tool to refer patients to care navigators. This tool is disabled for care coordinators during the period in which they are assigned to the control arm.
This study will employ an encouragement design, where patients who speak with intervention care coordinators are offered care navigation, but patients choose whether to participate in care navigation. Primary analyses will follow an intent-to-treat principle whereby care coordinators and patients will be analyzed according to the intervention arm to which they are assigned regardless of the subsequent sequence of events.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Care coordinators will be randomized to care navigation arm or services as usual arm at study outset and switch to the opposite arm halfway through the study.
| Arm | Type | Receives |
|---|---|---|
| Care Navigation | Experimental | Behavioral: Care NavigationMental health care coordinators are able to offer and refer patients to a care navigator in addition to offering substance use resources and treatment options as usual. |
| Services as Usual | No intervention | –Mental health care coordinators will continue offering substance use resources and treatment options to patients as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Care NavigationCare navigation is an intervention that seeks to help patients engage in substance use treatment by increasing motivation and reducing barriers to accessing treatment. The care navigator helps the patient engage in the treatment plan established by the mental health care coordinator. | Behavioural | Care Navigation |
Primary outcome
Engagement in treatment for substance use disorder
Time frame: 48 days
Completion of ≥ 3 treatment visits for substance use disorder within 48 days of their assessment visit
1 secondary outcome
Initiation of treatment for substance use disorder
Time frame: 30 days
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 27 Feb 2026.
- Derived from this study: PubMed 41035041Matson TE, Navarro MA, Idu A, Bobb JF, Patrick BM, Phillips R, Barrett TD, Rossi FS, Krawczyk N, Doud R, Rogers K, Davis CJ, Caldeiro R, Glass JE. Design of a cluster-randomized, hybrid type 1 effectiveness-implementation trial of a care navigation intervention to increase substance use disorder treatment engagement: study protocol. Addict Sci Clin Pract. 2025 Oct 1;20(1):78. doi: 10.1186/s13722-025-00605-7.
- Individual participant dataSharing planned: Yes. This study protocol is embedded within a Center of Excellence funded by the National Institute on Drug Abuse. In coordination with other center project components, the study protocol will be submitted for publication to either an addiction or implementation science journal. Additional data (analytic code) can be requested from the Principal Investigator. Participant data will be shared with the prime site as allowed. Analysis files will be constructed from the electronic data and aggregated. No names, addresses, telephone numbers, email addresses, medical record numbers, etc. will be retained in the aggregated files.
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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. This study is not recruiting at the moment.
Joseph E Glass, PhD, MSW principal investigator
Chestnut Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Navigation in people with Drug Use Disorders and Alcohol-Related Disorders, run by Kaiser Permanente at 1 site 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?
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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Engagement in treatment for substance use disorder (time frame: 48 days). 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 NCT06729957, 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 27 Feb 2026.