START Program for Opioid Addiction
(START Trial)
Trial Summary
What is the purpose of this trial?
This trial tests if a special hospital team (START) can help patients with opioid addiction by starting treatment in the hospital and planning for their care after they leave. The goal is to see if this approach improves treatment and reduces future health risks. The START intervention aims to improve care for hospitalized patients with opioid use disorder by initiating medication and linking them to post-discharge treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already receiving FDA-approved medication for opioid use disorder.
What data supports the effectiveness of the START treatment for opioid addiction?
The START NOW psychotherapy, part of the START treatment, has been shown to reduce disciplinary issues and psychiatric hospital stays in other settings, suggesting it may help with opioid addiction as well. Additionally, a redesigned substance use disorder program improved patient outcomes and reduced wait times, indicating that systematic approaches like START can be effective.12345
Is the START Program for Opioid Addiction safe for humans?
How is the START Program for Opioid Addiction different from other treatments?
The START Program for Opioid Addiction is unique because it integrates community-based treatment with buprenorphine-naloxone, a medication that can be used outside traditional opioid treatment programs, making it more accessible and practical for diverse settings. This approach combines medication with community support, which can enhance treatment engagement and success.910111213
Research Team
Itai Danovitch, MD
Principal Investigator
Cedars-Sinai Medical Center
Allison J Ober, PhD
Principal Investigator
RAND
Eligibility Criteria
This trial is for adults over 18 who are hospitalized with opioid use disorder (OUD) and not currently on FDA-approved medication for OUD. Participants must speak English or Spanish, be willing to do follow-up calls, and have a life expectancy of more than 6 months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Treatment
Participants receive the START intervention, including MOUD initiation and OUD-focused discharge planning, during their hospital stay
Follow-up
Participants are monitored for linkage to follow-up OUD care and post-discharge MOUD utilization
Post-discharge Monitoring
Participants' opioid use and outpatient medical care are tracked for 30 days post-discharge
Treatment Details
Interventions
- Substance Use Treatment and Recovery Team (START)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
National Center for Advancing Translational Science (NCATS)
Collaborator
RAND
Collaborator
University of New Mexico
Collaborator
Baystate Health
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Stanford University
Collaborator
University of Pittsburgh
Collaborator