Telehealth Treatment for Opioid Use Disorder

Overseen By Michael Pantalon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Buprenorphine, Methadone, Naltrexone

Disqualifiers: Pregnancy, Suicide risk, Incarceration, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth platform designed to help people with opioid use disorder (OUD) by reducing overdose events. The researchers aim to determine if this platform can motivate patients to engage more with their medication and assess its ease and satisfaction for both users and healthcare providers. Suitable participants include those who have experienced an opioid overdose, possess a smartphone or similar device, and have been diagnosed with moderate or severe OUD. As an unphased trial, this study offers participants the chance to contribute to innovative solutions for managing OUD and potentially enhance their own treatment experience.

Will I have to stop taking my current medications?

The trial requires that you are not currently using buprenorphine, methadone, or naltrexone for a substance use disorder. If you are taking any of these, you would need to stop before participating.

What prior data suggests that this telehealth platform is safe for treating opioid use disorder?

Research has shown that using telehealth to treat opioid use disorder (OUD) is generally safe and effective. One study found that patients using telehealth for medication-assisted treatment reduced their opioid use and experienced fewer overdoses, indicating they handled the treatment well. Another study focused on patients in rural areas and found that many continued their telehealth treatment, suggesting they found it acceptable.

Although the data does not directly address safety, the continued use and acceptance of telehealth treatment suggest it is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OUD Telehealth Platform because it offers a unique approach to treating opioid use disorder (OUD) by delivering care remotely. Unlike traditional in-person therapy or medication-assisted treatments like methadone or buprenorphine, this platform allows participants to access support and resources from the comfort of their own home. This can significantly reduce barriers to treatment, such as transportation issues or stigma associated with visiting a clinic. By leveraging technology, the platform aims to provide flexible, consistent, and personalized care, which could improve engagement and outcomes for individuals struggling with OUD.

What evidence suggests that the OUD Telehealth Platform is effective for reducing overdose events?

Research shows that using telehealth to treat Opioid Use Disorder (OUD) can be effective. In this trial, participants will receive the OUD Telehealth Platform, delivered remotely by research staff. Studies indicate that medication-assisted treatment (MAT) through telehealth helps patients stay in treatment longer and reduces opioid use and overdoses. Adding medications like methadone, buprenorphine, or naltrexone to therapy via telehealth results in fewer relapses compared to therapy alone. This method benefits rural areas, where accessing in-person treatment can be difficult. Overall, telehealth simplifies treatment continuation and improves patient outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Rebekah Heckmann, MD, MPH, MPA

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with a history of opioid overdose and diagnosed with moderate or severe Opioid Use Disorder. Participants must have access to a smartphone, tablet, or computer that can go online and receive texts, or be willing to use one provided by the study.

Inclusion Criteria

Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition

Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer) OR be willing to use a device provided by the study team

Can speak, read and write in English

Exclusion Criteria

I am currently using medication for substance addiction.

On parole or incarcerated at time of enrollment based on participant self-report

Known current suicide risk based on participant self-report

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the OUD Telehealth Platform intervention remotely

4 weeks

Remote sessions

Follow-up

Participants are monitored for engagement with MOUD and overdose events

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OUD Telehealth Platform

Trial Overview The study tests an OUD Telehealth Platform designed to encourage engagement in medications for treating opioid addiction. It will assess how well the platform works, its ease of use, and satisfaction among first responders/providers and participants.

How Is the Trial Designed?

Group I: OUD Telehealth Platform Experimental Treatment 1 Intervention

Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff.

OUD Telehealth Platform is already approved in United States for the following indications:

Approved in United States as Telehealth OUD Treatment for:

• Opioid Use Disorder (OUD)

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Patients using a fully virtual telemedicine service for opioid use disorder (tele-OUD) reported significant advantages, including a more patient-centered approach and reduced social barriers to treatment, based on interviews with 20 adults who had received 3 to 5 weeks of care.

Nearly all participants appreciated the quick initiation of medication for opioid use disorder (MOUD) through tele-OUD, indicating its potential effectiveness in improving access to treatment, although further research is needed to assess long-term outcomes and suitability for different recovery stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. Sousa, JL., Raja, P., Huskamp, HA., et al.[2023]

The HOPE mobile app was developed based on feedback from 16 interviews with patients and providers, incorporating features for mood tracking, treatment adherence, and community support, which were well-received by users.

In a 6-month pilot study with 25 patients, the app demonstrated high usability scores (mean 86.9 for patients and 83.3 for providers), indicating that it effectively supports individuals undergoing medication-assisted treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. Waselewski, ME., Flickinger, TE., Canan, C., et al.[2021]

Medication-assisted treatment with buprenorphine via telehealth is effective in improving access to care for adults with opioid use disorder (OUD), as highlighted by a study involving 15 participants who shared their positive experiences.

Despite the benefits of telehealth, participants reported feelings of isolation, indicating the need for healthcare providers to find ways to enhance patient engagement and support to mitigate this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Opioid Use Disorder Patients Receiving Buprenorphine Through a Telehealth Program. Moore, DJ., Goyal, D., Rodriguez, L.[2021]

Telehealth-delivered medication-assisted treatment for opioid use disorder (tele-MOUD) has shown favorable outcomes, including improved retention and abstinence rates, as well as positive experiences from both clinicians and patients, despite the need for more long-term assessments.

Challenges remain, particularly for underserved populations with limited access to technology, highlighting the need for additional support and permanent regulatory reforms to enhance the effectiveness and reach of tele-MOUD services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-Based Delivery of Medication-Assisted Treatment for Opioid Use Disorder: a Critical Review of Recent Developments. Mahmoud, H., Naal, H., Whaibeh, E., et al.[2022]

Three medications—methadone, naltrexone, and buprenorphine—are approved for treating opioid use disorder (OUD), and understanding their mechanisms is crucial for increasing treatment accessibility.

Primary care providers are well-positioned to deliver medication-assisted treatment (MAT) for OUD, especially in rural areas, but more research is needed to compare different MAT models and improve care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of medication-assisted treatment for opioid use disorder. Ghanem, N., Dromgoole, D., Hussein, A., 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7861202/

Outcomes for patients receiving telemedicine-delivered ... Effective evidence-based treatments for Opioid Use Disorder (OUD) exist. Methadone, buprenorphine, and naltrexone are all FDA approved for the treatment of OUD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04664062

Comparing Home, Office, and Telehealth Induction for ... HOMER is a national study comparing three methods of induction for Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD); home versus office ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S037687162500081X

The opioid epidemic in rural communities: Can telehealth ... This paper examines rural telehealth use, its impact on medication for opioid use disorder (MOUD) provision, and issues that require attention for sustainment.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9326140/

Telehealth-Based Delivery of Medication-Assisted ... Compared to standalone psychosocial treatment, the addition of MAT leads to reduction in opioid use and overdoses, reduced relapses, reduced ...

5. labs.sciety.org labs.sciety.org/articles/by?article_doi=10.20944/preprints202510.1694.v1

Telehealth-Delivered Medication-Assisted Treatment for ... Telehealth MAT improved patient retention compared with in-person MAT (log OR=0.32, 95% CI: [-1.09, 1.73]), was associated with a moderate ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05832879

Telehealth Treatment for Opioid Use Disorders This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10714254/

Retention in Telehealth Treatment for Opioid Use Disorder ... This was a retrospective cohort study of rural adults enrolled in telemedicine OUD treatment. Study outcomes were percent retained in care and adherence to ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816200

Telehealth Treatment for Opioid Use Disorder During ... This cohort study evaluates opioid use disorder (OUD) treatment and pregnancy outcomes among pregnant patients receiving OUD care through a

9. preprints.org preprints.org/manuscript/202510.1694/v1/download

Assisted Treatment for Opioid Use Disorder: A Systematic ... A study comprising. MAT for OUD provided through telehealth, detailing its efficacy, utilization, patient outcomes, or comparison studies ...