What side effects are associated with this type of intervention?

The most common treatments for Opioid Use Disorder (OUD) include methadone, buprenorphine, and naltrexone. Methadone can cause side effects such as constipation, sweating, sexual dysfunction, and respiratory depression. Buprenorphine's side effects include headache, nausea, constipation, and potential for precipitated withdrawal if started too soon after opioid use. Naltrexone can cause nausea, headache, dizziness, and liver enzyme abnormalities. These treatments are generally effective but require careful monitoring for side effects and adherence to prescribed protocols.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist used in maintenance therapy. Buprenorphine, a partial opioid agonist, is available in various formulations, such as Suboxone (buprenorphine/naloxone), to reduce misuse. Naltrexone, an opioid antagonist, is available in oral and extended-release injectable forms (Vivitrol) and is used to prevent relapse. These medications are integral to Medication for Opioid Use Disorder (MOUD) and align with the goals of the Collaborative Care Team trial, which aims to increase MOUD use and improve discharge planning for OUD patients.

What other types of research exist?

Promising, novel alternatives to the Collaborative Care Team for OUD patients include: 1) Digital health interventions such as telemedicine and mobile health apps that provide remote monitoring, support, and MOUD management. 2) Integrated care models that combine primary care, mental health services, and addiction treatment within a single healthcare setting. 3) Peer support programs that involve individuals with lived experience of OUD providing mentorship and support to patients. 4) Pharmacogenetic testing to tailor MOUD based on individual genetic profiles, potentially improving treatment outcomes. 5) Use of long-acting injectable formulations of MOUD to enhance adherence and reduce the need for frequent healthcare visits.

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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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 more

Awards & 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.

0 / 3Eligibility criteria met

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.