What side effects are associated with this type of intervention?

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, which blocks opioid receptors, can cause nausea, headache, dizziness, and liver enzyme abnormalities. These treatments, whether administered in-person or via telehealth, require careful monitoring to manage these side effects effectively.

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 that reduces withdrawal symptoms and cravings. Buprenorphine, a partial opioid agonist, is available in various formulations such as sublingual tablets and extended-release injections, and it helps to reduce cravings and withdrawal symptoms with a lower risk of misuse. Naltrexone, an opioid antagonist, blocks the effects of opioids and is available in oral and extended-release injectable forms. These medications are often used in Medication for Opioid Use Disorder (MOUD) programs, which can be initiated and managed through telehealth strategies to increase access to treatment, especially in rural areas.

What other types of research exist?

Promising novel alternatives to telehealth strategies for MOUD initiation in 2024 include: 1) Mobile health applications that provide real-time support and monitoring, 2) Community-based peer recovery programs that offer in-person support and resources, 3) Integration of MOUD services within primary care and emergency departments to facilitate immediate access to treatment, 4) Use of wearable technology for continuous monitoring and personalized feedback, and 5) Enhanced collaboration between healthcare providers and local support organizations to create a comprehensive care network.

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Telehealth Sociobehavioral Intervention for Opioid Addiction (REAL TTIME Trial)

N/A

Recruiting

Led By Emily Kiernan, DO

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months post intervention, and 1 year post intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial uses telehealth in emergency rooms to start addiction medication and connect patients to further care. It targets adults with opioid addiction in rural Georgia, where specialized treatment is scarce. The process involves video consultations with experts and support from recovery coaches.

Who is the study for?

This trial is for adults over 18 in rural Georgia who speak English and are medically stable, but struggling with opioid use disorder. They should not be currently receiving medication-assisted treatment or psychotherapy for OUD, nor have participated in this study before.

What is being tested?

The trial tests a new way to help people with opioid addiction by using telehealth in emergency departments. It involves medical toxicologists and peer recovery coaches working together to start treatment and connect patients to ongoing care.

What are the potential side effects?

Since the intervention is sociobehavioral rather than medicinal, traditional side effects like those seen with drugs are not expected. However, participants may experience emotional discomfort or stress during recovery coaching sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months post intervention, and 1 year post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months post intervention, and 1 year post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months post intervention, and 1 year post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of patients discharged with a prescription for MOUD

Change in number of patients evaluated for MOUD (Medication for Opioid Use Disorder)

Change in number of patients linked to a local RCO (Recovery Community Organization)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sociobehavioral program GroupExperimental Treatment1 Intervention

A novel sociobehavioral collaborative program that will improve the health of individuals in rural areas by expanding access to MOUD through an ED- based telemedicine strategy. Researchers will prospectively study a poison center OUD consultation and peer recovery coach (PRC) intervention as it is rolled out at each site, collecting participant-level data at baseline, one week post intervention and 30 days post intervention.

Group II: Control GroupActive Control1 Intervention

Patients who are seen at a participating hospital prior to the initiation of the intervention will be considered controls.

Do I qualify?Apply below to find out

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 buprenorphine and naltrexone. Buprenorphine is a partial opioid agonist that binds to opioid receptors, reducing cravings and withdrawal symptoms without producing a significant high. Naltrexone is an opioid antagonist that blocks opioid receptors, preventing the euphoric effects of opioids. These treatments are essential for OUD patients as they help manage withdrawal symptoms and reduce the risk of relapse, facilitating engagement in recovery programs and improving overall quality of life.