Telehealth for Opioid Use Disorder

Overseen By Shoshana Aronowitz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Buprenorphine

Disqualifiers: Non-English speakers, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 32

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies. The specific aims are to: 1) identify components of an effective telehealth intervention and barriers to implementation, 2) partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine, and 3) conduct a pilot trial of the telehealth intervention for OUD treatment. The investigators will enroll 60 patients, 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine, with a treatment episode duration of 1-3 months, and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician, to receive the telehealth for OUD care delivery intervention. The investigators will measure clinical, implementation, and patient satisfaction outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it seems that participants are expected to continue their treatment with buprenorphine (a medication for opioid use disorder) during the trial.

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

Research shows that using telehealth for opioid use disorder treatment, like prescribing medications such as buprenorphine, can be as effective as in-person visits. Studies found that telehealth helps keep patients engaged in their treatment and has similar retention rates and outcomes compared to face-to-face care. ^{1 2 3 4 5}

Is telehealth for opioid use disorder treatment safe for humans?

Telehealth for opioid use disorder treatment, including medications like Suboxone, Sublocade, and Probuphine, is generally considered safe for humans. These treatments have been developed to reduce misuse and ensure consistent medication delivery, which helps improve safety. However, specific safety data for telehealth delivery is still being evaluated, especially in the context of recent expansions due to the COVID-19 pandemic. ^{3 6 7 8 9}

How is telehealth for opioid use disorder treatment different from other treatments?

Telehealth for opioid use disorder treatment is unique because it allows patients to receive medication-assisted treatment, like buprenorphine, remotely through phone or video calls, increasing access to care, especially for those in rural areas or with mobility issues. This approach offers flexibility and convenience compared to traditional in-person visits, which can be more challenging for some patients to attend regularly. ^{3 10 11 12 13}

Eligibility Criteria

This trial is for individuals with opioid use disorder (OUD). It includes those currently in a 1-3 month buprenorphine treatment program and those approved for such treatment but not yet started. Participants must be willing to receive care via telehealth.

Inclusion Criteria

I work at Prevention Point Philadelphia in the buprenorphine OUD treatment program and care for at least one patient in the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a telehealth intervention for OUD treatment with buprenorphine, including a user-friendly telehealth platform, integrated case management, text message scheduling reminders, and mailed saliva urine drug screen testing.

12 weeks

Visits at baseline, weeks 2, 4, and 12

Follow-up

Participants are monitored for treatment engagement, substance use, and patient satisfaction at 30 and 90 days.

4 weeks

Follow-up visits at 30 and 90 days

Extension

Optional continuation of telehealth intervention for further evaluation and refinement of the model.

Long-term

Treatment Details

Interventions

• Telehealth for opioid use disorder treatment delivery

Trial Overview The study is testing a tailored telehealth intervention designed to improve OUD treatment delivery, specifically using the medication buprenorphine. The trial will develop this intervention with stakeholder input and measure its effectiveness through clinical outcomes and patient satisfaction.

Participant Groups

Group I: Patients with OUD, eligible for treatment with buprenorphine Experimental Treatment 1 Intervention

Telehealth for opioid use disorder treatment delivery is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Suboxone for:

• Opioid use disorder

Approved in European Union as Suboxone for:

• Opioid dependence

Approved in Canada as Suboxone for:

• Opioid use disorder

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

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]

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]

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

A study of 100 patients compared telepsychiatry and face-to-face buprenorphine medication-assisted treatment (MAT) for opioid use disorder, finding no significant differences in additional substance use or time to achieve 30 and 90 days of abstinence.

Both treatment methods showed similar retention rates at 90 and 365 days, suggesting that telepsychiatry is as effective as in-person treatment for managing opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. Zheng, W., Nickasch, M., Lander, L., et al.[2022]

Lofexidine is being developed to help manage withdrawal symptoms in opioid addiction, while Probuphine® offers a six-month delivery of buprenorphine, reducing concerns about misuse and child exposure.

New formulations like Suboxone® (sublingual film) and Vivitrol® (injectable depot) enhance safety and compliance in treatment, with Suboxone® being less prone to diversion and Vivitrol® providing consistent opioid receptor blockade for a month.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective review and commentary on emerging pharmacotherapies for opioid addiction. Ling, W., Mooney, L., Zhao, M., et al.[2021]

Two case studies of pregnant patients with opioid use disorder (OUD) who switched from sublingual buprenorphine to monthly injections of Sublocade® showed no adverse outcomes for either the mothers or their babies, suggesting potential safety in this treatment during pregnancy.

Both patients maintained positive urine drug screens for buprenorphine throughout their pregnancies without experiencing withdrawal symptoms or birth anomalies, indicating that Sublocade may be a viable option for managing OUD in pregnant women, although further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. Towers, CV., Deisher, H.[2022]

Long-acting buprenorphine formulations, including CAM 2038 (Buvidal), RBP-6000 (Sublocade™), and Probuphine™, provide effective options for treating opioid use disorders (OUDs) with varying administration schedules, such as weekly, monthly, or every six months.

These depot and implant formulations enhance patient adherence to treatment by reducing the frequency of dosing compared to traditional oral or sublingual medications, potentially improving overall outcomes in managing OUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. Soyka, M., Franke, AG.[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]

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]

The use of telehealth among physicians treating opioid use disorder (OUD) surged from 29% before COVID-19 to 66% during the pandemic, indicating a significant shift in practice.

Most physicians (54%) found telehealth to be more effective than they expected, and a large majority (85%) support making temporary telehealth regulations permanent, suggesting a strong preference for continued telehealth use post-pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician response to COVID-19-driven telehealth flexibility for opioid use disorder. Beetham, T., Fiellin, DA., Busch, SH.[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]

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. Italy pubmed.ncbi.nlm.nih.gov

Outcomes for patients receiving telemedicine-delivered medication-based treatment for Opioid Use Disorder: A retrospective chart review. [2022]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

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

Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Selective review and commentary on emerging pharmacotherapies for opioid addiction. [2021]

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

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. [2022]

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

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. [2021]

9. 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]

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

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

11. 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]

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

Physician response to COVID-19-driven telehealth flexibility for opioid use disorder. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Use of Telehealth for Opioid Use Disorder Treatment in Safety Net Primary Care Settings: A Mixed-Methods Study. [2023]