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Behavioral Intervention
START Program for Opioid Addiction (START Trial)
N/A
Waitlist Available
Led By Itai Danovitch, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Currently receiving FDA-approved medication treatment for an opioid use disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
The START program is being tested at three hospitals. It involves an addiction specialist and care manager helping patients get medication for OUD and planning post-discharge care. Patients will either receive this special team support or usual care.
What are the potential side effects?
Since the intervention focuses on collaborative care rather than a specific medical treatment, side effects may vary based on individual patient responses to medications used in their OUD treatment plan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently admitted as an inpatient at CSMC, UNM, or BH.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on FDA-approved medication for opioid addiction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
In-hospital initiation of MOUD therapy
Linkage to follow-up OUD care
Secondary study objectives
Any post-discharge MOUD utilization
OUD-specific discharge plan
Past 30-day number of days with any opioid use
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Substance Use Treatment and Recovery Team (START)Active Control1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Usual care for people with opioid use disorder.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Opioid Use Disorder (OUD) include medications such as methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist that reduces withdrawal symptoms and cravings by activating opioid receptors in the brain.
Buprenorphine is a partial opioid agonist that also alleviates withdrawal symptoms and cravings but with a ceiling effect that lowers the risk of misuse. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects.
These treatments are crucial as they help stabilize patients, reduce illicit opioid use, and improve overall functioning. Collaborative care teams, like those in the START trial, enhance the effectiveness of these treatments by providing comprehensive discharge planning and ongoing support, which increases adherence to MOUD and improves long-term outcomes for OUD patients.
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Who is running the clinical trial?
National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
35,842 Total Patients Enrolled
Cedars-Sinai Medical CenterLead Sponsor
509 Previous Clinical Trials
162,433 Total Patients Enrolled
RANDOTHER
140 Previous Clinical Trials
614,137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently admitted as an inpatient at CSMC, UNM, or BH.My primary language is either English or Spanish.I am currently on FDA-approved medication for opioid addiction.I am 18 years old or older.I am willing and able to participate in follow-up calls and provide my contact information.
Research Study Groups:
This trial has the following groups:- Group 1: Substance Use Treatment and Recovery Team (START)
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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