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Substance Use Treatment and Recovery Team
NA trial testing Substance Use Treatment and Recovery Team (START) in Opioid-use Disorder in 325 participants. Completed in 19 December 2023.
| Lead sponsor | Cedars-Sinai Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 325 |
| Start date | 11 November 2021 |
| Primary completion | 19 December 2023 |
| Estimated completion | 19 December 2023 |
| Sites | 3 locations across United States |
Cedars-Sinai Medical Center
18 and older, any sex, with Opioid-use Disorder or Opioid-Related Disorders. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Initiated MOUD prior to discharge, defined as use of any FDA-approved pharmacotherapy for OUD, including buprenorphine, naltrexone and methadone (Binary)
| Group | Value | 95% CI |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | 94 | |
| Usual Care | 43 |
Attended at least one OUD-related care visit within 30 days of hospital discharge (Binary)
| Group | Value | 95% CI |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | 90 | |
| Usual Care | 50 |
Received an after-hospital care plan that specifies a date and time for a post-discharge addiction care appointment (Binary)
| Group | Value | 95% CI |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | 81 | |
| Usual Care | 44 |
Initiated MOUD or continued MOUD treatment within 30 days following hospital discharge (Binary)
| Group | Value | 95% CI |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | 65 | |
| Usual Care | 32 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | 42 | |
| Usual Care | 19 |
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
| Group | Value | 95% CI |
|---|---|---|
| Substance Use Treatment and Recovery Team (START) | 0.0 | 0.0 – 10.0 |
| Usual Care | 0.0 | 0.0 – 14.0 |
Time frame: 90 days - from date of enrollment to end of follow-up period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Substance Use Treatment an… | Usual Care |
|---|---|---|---|
| Investigations | — | — | |
| Necrotizing oft-tissue infection (NSTI) | Infections and infestations | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Hospitalized | Psychiatric disorders | — | — |
| Reaction | System | Substance Use Treatment an… | Usual Care |
|---|---|---|---|
| Grievance | Social circumstances | — | — |
Most-reported serious reactions: , Necrotizing oft-tissue infection (NSTI), Cardiac arrest, Hospitalized.
Data from ClinicalTrials.gov NCT05086796 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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