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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for opioid use disorder using telehealth?

Research shows that using telehealth for opioid use disorder treatment, including medication like buprenorphine, can help people stay in treatment longer compared to traditional in-person visits. This approach can also overcome barriers like travel and cost, making it easier for people to access the care they need. ^{1 2 3 4 5}

Is telehealth treatment for opioid use disorder safe for humans?

The safety of telehealth treatment for opioid use disorder, which includes medication-assisted treatment (MAT) with medications like buprenorphine, is generally supported by research, as it is an established method for treating opioid addiction. While specific safety data for telehealth delivery is limited, MAT itself is a well-studied and safe approach for managing opioid use disorder. ^{2 3 4 6 7}

How is the OUD Telehealth Platform treatment different from other treatments for opioid use disorder?

The OUD Telehealth Platform is unique because it provides medication-assisted treatment (MAT) for opioid use disorder entirely through telehealth, making it more accessible and convenient for patients who may have difficulty attending in-person appointments. ^{2 3 4 5 7}

What is the purpose of this trial?

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 its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first responders/providers and participants.

Research Team

Rebekah Heckmann, MD, MPH, MPA

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Is Associated with Lower Risk of Discontinuation of Buprenorphine: a Retrospective Cohort Study of US Veterans. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Experiences of Opioid Use Disorder Patients Receiving Buprenorphine Through a Telehealth Program. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

When a pandemic and epidemic collide: Lessons learned about how system barriers can interrupt implementation of addiction research. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Telehealth-Based Delivery of Medication-Assisted Treatment for Opioid Use Disorder: a Critical Review of Recent Developments. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Perspectives of Patients Receiving Telemedicine Services for Opioid Use Disorder Treatment: A Qualitative Analysis of User Experiences. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Review of medication-assisted treatment for opioid use disorder. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Health App to Support Patients Receiving Medication-Assisted Treatment for Opioid Use Disorder: Development and Feasibility Study. [2021]