Telehealth vs In-Person Treatment for Opioid Use Disorder

(TREATED Trial)

Recruiting at 2 trial locations

Overseen By Stephen Henry, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must be taking: Buprenorphine

Disqualifiers: Inability to consent, Institutionalized, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if starting opioid addiction treatment via telehealth is as effective as starting it in person after an emergency room visit. Researchers seek to understand whether telehealth can help patients adhere to their treatment and improve their overall experience. Participants will include individuals who have started buprenorphine (a medication for opioid use disorder) in the emergency department but lack an outpatient clinic for follow-up care. They will complete surveys at various points to compare the outcomes of telehealth versus in-person visits. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment accessibility and patient experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on starting buprenorphine treatment for opioid use disorder.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that starting buprenorphine treatment for opioid use disorder (OUD) through telehealth can help patients remain in treatment longer. This indicates that telehealth is a safe and effective option. During the COVID-19 pandemic, relaxed telehealth rules made it easier for people to access care, and studies found that these changes helped save lives.

Both telehealth and in-person treatments use buprenorphine, a well-known medication for OUD that has been safely used for many years. While side effects can occur, they are usually mild and manageable, such as nausea, headache, and sweating. Serious side effects are rare.

The safety of these treatments is supported by their widespread use and positive results in past studies. With both options available, participants can choose the method that best suits their needs while still receiving safe and effective treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring telehealth for treating opioid use disorder (OUD) because it offers a flexible and accessible alternative to traditional in-person care. Unlike the standard in-person treatment that requires patients to physically visit clinics, telehealth allows patients to receive care through phone or video calls, which can be particularly beneficial for those with limited access to healthcare facilities or transportation challenges. This method maintains the comprehensive support of in-person programs, including counseling and medication like buprenorphine, but makes it accessible from home. By potentially reducing barriers to care, telehealth could help more people start and continue OUD treatment, improving overall outcomes.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

This trial will compare telehealth addiction treatment with in-person addiction treatment for opioid use disorder (OUD). Research has shown that telehealth is a safe and effective method for treating OUD. Studies have found that retention and success rates are similar for both in-person and telehealth treatments. Specifically, one study found that over 80% of patients were satisfied with the quality of telehealth services. Other research suggests that telehealth does not result in worse outcomes compared to in-person care. Thus, receiving OUD treatment through phone or video calls can be as effective as visiting a clinic. ^{3 6 7 8 9}

Who Is on the Research Team?

Stephen G Henry, MD MSc

Principal Investigator

University of California, Davis

Aimee Moulin, MD MAS

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for individuals who have visited the emergency department due to opioid dependence or use disorder and are starting buprenorphine treatment. Participants will be recruited from three different hospital emergency departments.

Inclusion Criteria

I received buprenorphine in the emergency department for opioid use disorder.

I don't have a clinic to get buprenorphine after leaving the ER.

Exclusion Criteria

Patients living in institutions (e.g., nursing homes, prisons)

Unable to complete questionnaires in either English or Spanish

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive buprenorphine treatment initiated in the emergency department and are referred to either in-person or telehealth outpatient treatment

6 months

Initial visit in emergency department, followed by outpatient visits via telehealth or in-person

Follow-up

Participants are monitored for treatment retention, healthcare utilization, and patient experience with care

9 months

Questionnaires at 1, 3, 6, and 9 months

Long-term follow-up

Participants' long-term buprenorphine retention and overdose outcomes are assessed

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• In-Person Addiction Treatment
• Telehealth Addiction Treatment

Trial Overview

The study aims to compare long-term outcomes of buprenorphine treatment when patients receive follow-up care via telehealth versus in-person clinics after an initial emergency department visit. It measures how well they establish and maintain outpatient treatment, as well as their care experience.

How Is the Trial Designed?

Group I: telehealth Experimental Treatment 1 Intervention

This arm will comprise the same elements as the "in person" arm except that patients will be referred to get outpatient OUD treatment via telehealth (i.e. phone or video visits). Depending on study site and patient insurance, participants will be referred to get treatment at either a clinic associated with their hospital that offers telehealth OUD treatment or from a digital health company that provides on-demand telehealth OUD treatment and support services via video and phone visits.

Group II: in person Active Control 1 Intervention

Participants will get treatment via CA Bridge, California's statewide program to provide Emergency Department (ED)-based OUD treatment. When clinicians or staff suspect an ED patient may have OUD, they refer the patient to an ED-based counselor who assesses the patient and engages them in OUD care. All patients with OUD get brief counseling and take-home naloxone. Patients willing to start treatment get buprenorphine (via either ED- or home-based induction), a referral for in-person outpatient OUD treatment at a local outpatient clinic or opioid treatment program, and a "bridge" prescription of buprenorphine to last until their first outpatient appointment. CA Bridge counselors maintain contact with patients for up to 30 days to help them establish outpatient care. This is usual care in study hospitals and in the \>80% of California hospitals that participate in CA Bridge.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

A retrospective chart review of 472 patients treated via telemedicine for opioid use disorder (OUD) from August 2015 to April 2019 showed that prescribing medications like buprenorphine and naltrexone is effective in a rural setting.

The study found that retention rates and toxicology results for patients receiving telemedicine treatment were comparable to those receiving traditional face-to-face treatment, suggesting that telemedicine can be a viable option for OUD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes for patients receiving telemedicine-delivered medication-based treatment for Opioid Use Disorder: A retrospective chart review. Weintraub, E., Greenblatt, AD., Chang, J., et al.[2022]

The COVID-19 pandemic has led to an increased use of telehealth for treating opioid use disorder (OUD), creating opportunities to study how different care methods impact patient outcomes.

Key questions about the quality of care for OUD, such as the necessity of physical exams and the effectiveness of telehealth check-ins versus in-person visits, need to be addressed to ensure patients receive effective and patient-centered treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and supporting high-quality telehealth for patients with opioid use disorder: The promise and potential pitfalls of telehealth expansion. Frank, CJ., Lin, LA.[2023]

New patients, those with psychiatric diagnoses, and patients at rural clinics were less likely to have their opioid use disorder (OUD) visits conducted via telehealth, indicating that certain patient characteristics influence the mode of care delivery.

Telehealth provided flexibility for patients, but in-person visits were preferred for building rapport, especially with new patients and those facing psychological challenges, highlighting the need for a balanced approach in OUD treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telehealth for Opioid Use Disorder Treatment in Safety Net Primary Care Settings: A Mixed-Methods Study. Bailey, SR., Wyte-Lake, T., Lucas, JA., et al.[2023]

A study involving 360 patients with substance use disorders found that both telehealth and in-person treatment led to improvements in substance use, as measured by the Drug Use Disorders Identification Test - Consumption (DUDIT-C) scores.

There was no significant difference in treatment outcomes between telehealth and in-person care, indicating that telehealth is an effective alternative for treating substance use disorders in rural outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Drug Use Disorders Identification Test - Consumption (DUDIT-C) with Telehealth Treatment Compared to in-Person Treatment. Neufeld, J., Ullrich, F., Merchant, KAS., et al.[2023]

A study of Veterans with opioid use disorder found that using telehealth for counseling significantly reduced the likelihood of discontinuing buprenorphine treatment compared to traditional in-person visits, with a hazard ratio of 0.69 for both substance use and mental health services.

Patients who exclusively used telehealth had an even lower risk of treatment discontinuation (hazard ratios of 0.48 for substance use and 0.46 for mental health), suggesting that telehealth can effectively support ongoing engagement in treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. Vakkalanka, JP., Lund, BC., Ward, MM., et al.[2022]

The study evaluated the MySafeRx mobile app, which combines remote motivational recovery coaching with supervised dosing via videoconference, aiming to improve medication adherence in patients undergoing buprenorphine treatment for opioid use disorder (OUD).

Implementation of the telehealth intervention faced significant challenges, including institutional barriers, staff burnout, and rigid protocols, highlighting the need for adaptable solutions in addiction treatment as telehealth becomes increasingly important in addressing the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When a pandemic and epidemic collide: Lessons learned about how system barriers can interrupt implementation of addiction research. Sharp, A., Carlson, M., Vroom, EB., et al.[2023]

Patients with substance use disorders who used telehealth services via video in the first 14 days of treatment had a significantly lower risk of dropout compared to those receiving only in-person services, indicating that telehealth can enhance retention in treatment.

Early engagement in treatment was notably higher for patients using telehealth, both via video and telephone, compared to those receiving in-person care, suggesting that telehealth may improve initial treatment uptake for individuals seeking help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Telehealth on Dropout and Retention in Care among Treatment-Seeking Individuals with Substance Use Disorder: A Retrospective Cohort Study. Gainer, DM., Wong, C., Embree, JA., et al.[2023]

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