Opioid-use DisorderSTARTNCT05086796
Substance Use Treatment and Recovery Team
A study testing Substance Use Treatment and Recovery Team (START) in people with Opioid-use Disorder and Opioid-Related Disorders, run by Cedars-Sinai Medical Center at 3 sites in United States.
Trial summary
This study is a multi-site, randomized pragmatic trial being conducted at three diverse sites. The study, called the Substance Use Treatment and Recovery Team (START), will evaluate whether a collaborative care team increases the use of two interventions-medication for opioid use disorder (MOUD), and opioid use… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Opioid-Related Disorders
- What is being tested?
- Substance Use Treatment and Recovery Team (START)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Nov 2021to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admitted to an inpatient bed at Cedars-Sinai Medical Center (CSMC),University of New Mexico Hospital (UNM), or Baystate Health (BH)
- Age 18 and older
- Have a probable OUD diagnosis, defined by scores of > 3 on the opioid section of the Alcohol, Smoking, and Substance Involvement Screening test (ASSIST)
- Speaks English or Spanish as primary language
- Willing to participate in follow-up calls and interview by telephone and able to provide contact information for follow-up calls
- Able to provide informed consent
Who cannot join
- Currently receiving FDA-approved medication treatment for an opioid use disorder
- < 6 months life expectancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
Cedars Sinai Medical Center
Los Angeles, California, 90048
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
This study is a multi-site, randomized pragmatic trial being conducted at three diverse sites. The study, called the Substance Use Treatment and Recovery Team (START), will evaluate whether a collaborative care team increases the use of two interventions-medication for opioid use disorder (MOUD), and opioid use disorder (OUD) focused discharge planning-among hospitalized patients with OUD, and improves linkage to follow-up care relative to usual care. The START consists of an addiction medicine specialist and a care manager who will use evidence-based tools to decrease barriers to MOUD and engage patients with post-discharge OUD care. A total of 414 patients will be randomized from Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts to receive either START or usual care, stratifying by prior MOUD exposure and site.
Read the detailed description
In the past decade, hospitalizations for OUD nearly doubled. Patients admitted to the hospital with an underlying OUD rarely receive evidence-based treatment for OUD while hospitalized. MOUD is not commonly initiated in the hospital, and patients are seldom linked to outpatient treatment after discharge. Hospitalized patients with OUD who do not initiate MOUD or receive linkage to post-discharge treatment are at high-risk of continued misuse, delays in care, future overdose and costly readmission. This study identifies the inpatient hospital stay as a key opportunity to initiate MOUD and link patients with follow-up care for OUD.
The Substance Use Treatment and Recovery Team (START) is an intervention that adapts the principles of collaborative care to the hospital setting. Prior studies have demonstrated the effectiveness of collaborative care in outpatient settings for patients with opioid and alcohol use disorders, and a series of reports have demonstrated the feasibility and potential efficacy of hospital based consultative teams for substance use disorders. START uses team based, multi-faceted interventions (ie: motivational interviewing, medication treatment, OUD-focused discharge planning), measurement-based care, and patient registries to increase delivery of evidence-based care. The goal of START is to facilitate initiation of MOUD during the inpatient stay and link patients to appropriate post-discharge care.
The START study is a multi-site, randomized trial that will evaluate the intervention improves MOUD initiation and linkage to follow-up care among hospitalized patients with OUD. A total of 414 patients will be randomized from three geographically diverse hospitals (Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts) to receive either START or usual care, stratifying by prior MOUD exposure and site. The study builds on a pilot randomized controlled trial conducted at Cedars-Sinai by testing the intervention at three geographically distinct locations, thus increasing generalizability.
If the aims of the research are achieved, the investigators will learn whether this model of care increases OUD treatment delivery in general medical hospitals, and decreases the downstream effects of untreated OUD. If effective, this translational model also can be used to increase uptake of evidence-based practices for other substance use and behavioral health disorders.
- Conditions
- Opioid-use Disorder, Opioid-Related Disorders
- Being tested
- Substance Use Treatment and Recovery Team (START)
- Keywords
- Collaborative Care, Hospital, Addiction, Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance Use Treatment and Recovery Team (START)Behavioural
START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid use disorder and to increase linkage to aftercare.
The components of the START intervention are as follows:
- Triage
- Engage, Assess, and Plan
- Treat
- Communicate and Coordinate
- Follow up
- Monitor
| Study group | Role | What they receive |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | Active comparator | The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. Receives: Behavioral: Substance Use Treatment and Recovery Team (START) |
| Usual Care | No intervention | Usual care for people with opioid use disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital Initiation of MOUD Therapy
Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)
Measured: During the inpatient stay, an average of 7 days
Linkage to Follow-up OUD Care
Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
Measured: 30 days
Secondary outcomes (4)
OUD-specific Discharge Plan
Received an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)
Measured: During the inpatient stay, an average of 7 days
Any Post-discharge MOUD Utilization
Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)
Measured: 30 days
Post-discharge Outpatient Medical Care
Completed at least one visit to an outpatient medical provider within 30 days of hospital discharge (Binary). Visit must be specifically related to opioid use and may include an emergency department visit.
Measured: 30 days
Past 30-day Number of Days With Any Opioid Use
Days of use in the past 30 days after hospital discharge - Adapted National Survey of Drug Use and Health (NSDUH) (Continuous). "Use-days" range from 0 to 120 days with up to 30 days of use reportable for each of four opioid categories: pain medications excluding fentanyl, fentanyl, heroin/opium alone, heroin/opium mixed with another drug
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 posted21 Oct 2021
- Study start11 Nov 2021
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- RAND, University of New Mexico, Baystate Health, National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA), Stanford University, University of Pittsburgh
- Responsible party
- Principal investigator, Itai Danovitch, Cedars-Sinai Medical Center
- Investigators
- Itai Danovitch, MD, Principal investigator, Cedars-Sinai Medical CenterAllison J Ober, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086796
- Sponsor's protocol ID
- STUDY00000515
- Other IDs
- 5U01TR002756-02, 1U01TR002756-01A1
- Acronym
- START
- Status last verified
- Jan 2025
- First submitted
- 12 Oct 2021
- Last updated
- 23 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data and associated documentation will be made available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
Publications
Ober AJ, Murray-Krezan C, Page K, Friedmann PD, Anderson J, Osilla KC, Ryzewicz S, Huerta S, Mazer MW, Hoskinson RA, Garvey R, Peltz A, Watkins KE, Nuckols T, IsHak WW, Mariano LT, Danovitch I. Hospital Addiction Consultation Service and Opioid Use Disorder Treatment: The START Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):624-633. doi: 10.1001/jamainternmed.2024.8586.
PubMed 40193131Ober AJ, Murray-Krezan C, Page K, Friedmann PD, Chan Osilla K, Ryzewicz S, Huerta S, Mazer MW, Leamon I, Messineo G, Watkins KE, Nuckols T, Danovitch I. The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder. Addict Sci Clin Pract. 2022 Jul 28;17(1):39. doi: 10.1186/s13722-022-00320-7.
PubMed 35902888
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Treatment and Recovery Team
- ClinicalTrials.gov ID
- NCT05086796
- Acronym / sponsor ID
- START / STUDY00000515
- Conditions
- Opioid-use Disorder, Opioid-Related Disorders
- Keywords
- Collaborative Care, Hospital, Addiction, Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- RAND, University of New Mexico, Baystate Health, National Center for Advancing Translational Sciences (NCATS), National Institute on Drug Abuse (NIDA), Stanford University, University of Pittsburgh
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-site, randomized pragmatic trial being conducted at three diverse sites. The study, called the Substance Use Treatment and Recovery Team (START), will evaluate whether a collaborative care team increases the use of two interventions-medication for opioid use disorder (MOUD), and opioid use disorder (OUD) focused discharge planning-among hospitalized patients with OUD, and improves linkage to follow-up care relative to usual care. The START consists of an addiction medicine specialist and a care manager who will use evidence-based tools to decrease barriers to MOUD and engage patients with post-discharge OUD care. A total of 414 patients will be randomized from Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts to receive either START or usual care, stratifying by prior MOUD exposure and site.
Detailed description
In the past decade, hospitalizations for OUD nearly doubled. Patients admitted to the hospital with an underlying OUD rarely receive evidence-based treatment for OUD while hospitalized. MOUD is not commonly initiated in the hospital, and patients are seldom linked to outpatient treatment after discharge. Hospitalized patients with OUD who do not initiate MOUD or receive linkage to post-discharge treatment are at high-risk of continued misuse, delays in care, future overdose and costly readmission. This study identifies the inpatient hospital stay as a key opportunity to initiate MOUD and link patients with follow-up care for OUD.
The Substance Use Treatment and Recovery Team (START) is an intervention that adapts the principles of collaborative care to the hospital setting. Prior studies have demonstrated the effectiveness of collaborative care in outpatient settings for patients with opioid and alcohol use disorders, and a series of reports have demonstrated the feasibility and potential efficacy of hospital based consultative teams for substance use disorders. START uses team based, multi-faceted interventions (ie: motivational interviewing, medication treatment, OUD-focused discharge planning), measurement-based care, and patient registries to increase delivery of evidence-based care. The goal of START is to facilitate initiation of MOUD during the inpatient stay and link patients to appropriate post-discharge care.
The START study is a multi-site, randomized trial that will evaluate the intervention improves MOUD initiation and linkage to follow-up care among hospitalized patients with OUD. A total of 414 patients will be randomized from three geographically diverse hospitals (Cedars-Sinai Medical Center in Los Angeles, the University of New Mexico Hospital in Albuquerque, and Baystate Health in Springfield, Massachusetts) to receive either START or usual care, stratifying by prior MOUD exposure and site. The study builds on a pilot randomized controlled trial conducted at Cedars-Sinai by testing the intervention at three geographically distinct locations, thus increasing generalizability.
If the aims of the research are achieved, the investigators will learn whether this model of care increases OUD treatment delivery in general medical hospitals, and decreases the downstream effects of untreated OUD. If effective, this translational model also can be used to increase uptake of evidence-based practices for other substance use and behavioral health disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | Active comparator | Behavioral: Substance Use Treatment and Recovery Team (START)The intervention is administered to participants in this arm. Participants in this arm will work with the Substance Use Treatment and Recovery Team (START), a collaborative care team for inpatients with opioid use disorder. |
| Usual Care | No intervention | –Usual care for people with opioid use disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to an inpatient bed at Cedars-Sinai Medical Center (CSMC),University of New Mexico Hospital (UNM), or Baystate Health (BH)
- Age 18 and older
- Have a probable OUD diagnosis, defined by scores of > 3 on the opioid section of the Alcohol, Smoking, and Substance Involvement Screening test (ASSIST)
- Speaks English or Spanish as primary language
- Willing to participate in follow-up calls and interview by telephone and able to provide contact information for follow-up calls
Key exclusion criteria (2 listed)
- Currently receiving FDA-approved medication treatment for an opioid use disorder
- < 6 months life expectancy
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 |
|---|---|---|
| Substance Use Treatment and Recovery Team (START)START is a model of care based on Collaborative Care. START is team driven, population-focused, measurement based, and focused on promoting adoption of evidence-based interventions. The purpose of this model is to increase adoption of evidence-based interventions for opioid use disorder and to increase linkage to aftercare. The components of the START intervention are as follows: 1. Triage 2. Engage, Assess, and Plan 3. Treat 4. Communicate and Coordinate 5. Follow up 6. Monitor | Behavioural | Substance Use Treatment and Recovery Team (START) |
Primary outcome
In-hospital Initiation of MOUD Therapy
Time frame: During the inpatient stay, an average of 7 days
Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)
Linkage to Follow-up OUD Care
Time frame: 30 days
Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
4 secondary outcomes
OUD-specific Discharge Plan
Time frame: During the inpatient stay, an average of 7 days
Any Post-discharge MOUD Utilization
Time frame: 30 days
Post-discharge Outpatient Medical Care
Time frame: 30 days
Past 30-day Number of Days With Any Opioid Use
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40193131Ober AJ, Murray-Krezan C, Page K, Friedmann PD, Anderson J, Osilla KC, Ryzewicz S, Huerta S, Mazer MW, Hoskinson RA, Garvey R, Peltz A, Watkins KE, Nuckols T, IsHak WW, Mariano LT, Danovitch I. Hospital Addiction Consultation Service and Opioid Use Disorder Treatment: The START Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):624-633. doi: 10.1001/jamainternmed.2024.8586.
- Derived from this study: PubMed 35902888Ober AJ, Murray-Krezan C, Page K, Friedmann PD, Chan Osilla K, Ryzewicz S, Huerta S, Mazer MW, Leamon I, Messineo G, Watkins KE, Nuckols T, Danovitch I. The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder. Addict Sci Clin Pract. 2022 Jul 28;17(1):39. doi: 10.1186/s13722-022-00320-7.
- Individual participant dataSharing planned: Yes. The data and associated documentation will be made available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
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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.
Itai Danovitch, MD principal investigator
Cedars-Sinai Medical Center
Allison J Ober, PhD principal investigator
RAND
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Substance Use Treatment and Recovery Team (START) in people with Opioid-use Disorder and Opioid-Related Disorders, run by Cedars-Sinai Medical Center at 3 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 6 inclusion and 2 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 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
In-hospital Initiation of MOUD Therapy (time frame: During the inpatient stay, an average of 7 days). The study lists 2 primary outcomes in all. 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 NCT05086796, which also lists 2 linked publications.
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 23 Jan 2025.