Telehealth Treatment for Opioid Use Disorder

Overseen By Rebekah Heckmann, MD

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)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a telehealth platform called RecoveryPad assists individuals with moderate or severe opioid use disorder. Participants will either use RecoveryPad or receive the usual treatment, which includes referrals to community resources. The trial seeks individuals who speak English, have been diagnosed with opioid use disorder, and possess a smartphone or computer with internet access. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in telehealth solutions.

What prior data suggests that the RecoveryPad platform is safe for treating opioid use disorder?

Research shows that the RecoveryPad platform is designed to assist people with opioid use disorder in finding treatments, such as medication for opioid use disorder (MOUD). Although specific safety information about RecoveryPad is limited, studies have shown that using telehealth for treatment is generally safe. Telehealth can simplify access to necessary treatments without requiring in-person doctor visits.

While no specific side effects have been reported for RecoveryPad, the study phase is labeled "Not Applicable," indicating that detailed safety information might not yet be available. However, telehealth platforms are typically well-received because they allow patients to receive care in a comfortable setting, such as their home. Prospective trial participants can expect a focus on using technology to enhance access to treatment, with safety remaining a top priority as more information becomes available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RecoveryPad platform because it offers a new way to tackle opioid use disorder through telehealth. Unlike traditional treatments that often require in-person visits, RecoveryPad provides support and resources remotely, making it more accessible to people who may not have easy access to healthcare facilities. This platform leverages technology to deliver therapy and support directly to individuals wherever they are, potentially increasing engagement and adherence to treatment plans. By integrating digital tools with addiction treatment, RecoveryPad could revolutionize how we approach recovery and make support more inclusive and convenient.

What evidence suggests that the RecoveryPad platform is effective for opioid use disorder?

Research shows that RecoveryPad, a telehealth platform, might help treat opioid use disorder (OUD). In this trial, participants will be randomized to either the RecoveryPad platform or receive treatment as usual. Studies have found that digital tools like RecoveryPad can facilitate access to medication-assisted treatment, which is crucial for managing OUD. Early results suggest that RecoveryPad enables patients to connect with treatment providers more quickly. This faster access can lead to better treatment outcomes. Overall, the platform aims to help people with OUD start and continue their treatment more effectively. ^{1 2 3 6 7}

Who Is on the Research Team?

Rebekah Heckmann, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with moderate or severe opioid use disorder who can communicate in English and have access to a smartphone, tablet, or computer. They must be willing to provide an email address and consent form. Those at suicide risk, pregnant or lactating women, individuals on parole/incarcerated, or currently using certain medications for substance abuse cannot participate.

Inclusion Criteria

Can provide a working email address OR be willing to create one

Can speak, read and write in English

Provision of signed and dated informed consent form

Exclusion Criteria

I do not currently feel at risk of harming myself.

Pregnancy or lactation

On parole or incarcerated at time of enrollment 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 are enrolled in the RecoveryPad telehealth platform or receive treatment as usual

12 weeks

Telehealth sessions as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RecoveryPad

Trial Overview

The RecoveryPad (RP) telehealth platform is being tested in this trial. It's designed to help people with opioid addiction through online tools and resources. Participants will use RP to see if it improves their treatment outcomes compared to standard care practices.

How Is the Trial Designed?

Group I: RecoveryPad platform Experimental Treatment 1 Intervention

Participants randomized to RecoveryPad platform

Group II: Treatment as usual Active Control 1 Intervention

Treatment as usual: referrals to harm reduction and other community resources that are already being given to individuals in the various community and healthcare settings from which these participants are being recruited.

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12658510/

Increasing timely access to evidence-based treatment ... - PMC

This pilot study will test the feasibility of RecoveryPad to link eligible participants to initiate MOUD while collecting data to inform ongoing ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41193189/

Increasing timely access to evidence-based treatment for ...

Increasing timely access to evidence-based treatment for opioid use disorder using novel digital health and system dynamics modelling approaches ...

3.

hd2arasc.org

hd2arasc.org/rapid-dims-summaries/

2023 DISC Rapid Data Infrastructure Modernization ...

Our long-term goal is to leverage high-quality and timely local data to improve opioid use disorder (OUD) outcomes before, during, and after pregnancy. This ...

4.

researchgate.net

researchgate.net/figure/Intervention-testing-outcomes-as-of-2030-OUD-opioid-use-disorder-ED-emergency_tbl1_342063685

Intervention testing outcomes as of 2030. OUD, opioid use ...

Background Simulation models of opioid use disorder (OUD) aim at evaluating the impact of different treatment strategies on population-level outcomes.

5.

bmjopen.bmj.com

bmjopen.bmj.com/content/bmjopen/15/11/e102796.draft-revisions.pdf

BMJ Open is committed to open peer review. As ...

with opioid use disorder (OUD) to access MOUD treatment providers for telehealth initiation of ... platform ... RecoveryPad © to improve treatment outcomes for ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9705076/

Using Data Science to Improve Outcomes for Persons with ...

Even if patients receive MOUD, 40%-55% of persons discontinue MOUD within a year after initiation, and recent data show a six-fold increase in mortality in the ...

7.

researchgate.net

researchgate.net/publication/397293186_Increasing_timely_access_to_evidence-based_treatment_for_opioid_use_disorder_using_novel_digital_health_and_system_dynamics_modelling_approaches_a_study_protocol

Increasing timely access to evidence-based treatment ...

Increasing timely access to evidence-based treatment for opioid use disorder using novel digital health and system dynamics modelling approaches ...