RAE Digital Tool for Substance Use Disorder

Overseen By Melissa Taylor, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: ContinueYou, LLC

Disqualifiers: Pregnancy, Prisoner status, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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 aims to test a new digital tool called RAE, which may assist individuals in treatment for substance use disorder by identifying signs of stress and drug cravings. Participants will either use the RAE app alongside their usual care or receive only the usual care. The trial seeks individuals who have been in an outpatient substance use disorder treatment program for less than 90 days and have access to a smartphone. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the RAE digital tool is safe for individuals with substance use disorder?

Research shows that most people find the RAE digital tool easy to use. Studies have found that digital tools like RAE can help manage substance use disorder by offering calming techniques and support. In past research, users reported no major negative effects when using digital tools for recovery. As a digital tool, RAE avoids the physical side effects often associated with medication treatments. This trial is in the later stages, indicating that earlier research has found the tool to be safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RAE Digital Tool for Substance Use Disorder because it leverages technology to potentially enhance treatment outcomes. Unlike standard care options that may include therapy, medication, and support groups, RAE integrates a wearable sensor with a mobile app to provide real-time feedback and personalized support. This innovative approach aims to promote engagement and adherence, offering a more interactive and data-driven way to support recovery. By providing users with immediate insights and tailored interventions, RAE could transform how individuals manage substance use disorder.

What evidence suggests that the RAE digital tool is effective for substance use disorder?

Research shows that digital tools like the RAE app can assist people with substance use problems by detecting stress and cravings for drugs in real-time. In this trial, participants in the interventional arm will receive the RAE app alongside usual care. One study found that, when combined with regular treatments, digital tools like RAE effectively help people with opioid use issues, potentially reducing the risk of relapse. Early research suggests that the RAE app may improve treatment outcomes by providing support when needed most. ^{1 2 3 4 6}

Who Is on the Research Team?

Megan Reinhardt

Principal Investigator

ContinueYou, LLC

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are in the early stages (less than 90 days) of outpatient treatment for substance use disorders. Participants must have a smartphone with iOS or Android, speak English fluently, and be able to give informed consent. Pregnant individuals, prisoners, or those with significant arm disabilities cannot participate.

Inclusion Criteria

Have access to a smartphone with iOS or Android capabilities

Capable of providing informed consent

Enrolled in treatment for less than 90 days

Exclusion Criteria

Prisoner status

My non-dominant arm has limited movement due to amputation or fracture.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the RAE system (mobile app and wearable sensor) or a fitness tracker for a minimum of 30 days

4 weeks

Regular use of mobile app and wearable sensor

Follow-up

Participants are monitored for retention in treatment, return to substance use, and overall psychosocial functioning

3 months

What Are the Treatments Tested in This Trial?

Interventions

• RAE

Trial Overview The RAE study is testing how well digital biomarkers can detect stress and drug cravings in people getting treated for substance use disorder. It aims to understand if these markers can help improve adherence to treatment programs.

How Is the Trial Designed?

Group I: Interventional (RAE + Usual Care) Experimental Treatment 1 Intervention

Subjects will receive usual care through an outpatient substance use disorder treatment facility, will be provided with a wearable sensor and the RAE mobile application. Participants will be instructed to use the RAE app for a minimum of 30 days.

Group II: Control (Usual care) Active Control 1 Intervention

Subjects will receive usual care through an outpatient substance use disorder treatment facility and will be provided with a wearable sensor (fitness tracker). They will not be given access to the RAE mobile app.

Who Is Running the Clinical Trial?

ContinueYou, LLC

Lead Sponsor

Trials

1

Recruited

210+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

University of Texas at Tyler

Collaborator

Trials

5

Recruited

900+

Published Research Related to This Trial

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

Computer-based interventions for drug use disorders have shown high acceptability and can lead to reduced substance use, increased motivation to change, and better retention compared to traditional treatment methods, based on a review of 12 studies.

These interventions offer a promising alternative due to their lower cost and greater accessibility, suggesting they could significantly transform treatment approaches for drug use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. Moore, BA., Fazzino, T., Garnet, B., et al.[2022]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

In a study of 3144 patients with opioid use disorder, the prescription digital therapeutic (PDT) reSET-O showed high engagement, with 80% of patients completing at least 8 out of 67 therapeutic modules, which is linked to improved treatment outcomes.

Patients who engaged with reSET-O demonstrated significant abstinence rates, with 66% abstinent in the last 4 weeks of treatment and 91% meeting the responder definition, indicating that this digital tool can effectively support traditional buprenorphine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Maricich, YA., Xiong, X., Gerwien, R., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7978415/

Realize, Analyze, Engage (RAE): A Digital Tool to Support ... RAE is a digital, mHealth intervention that focusses on real time, objective detection of high-risk events (stress and drug craving) to deploy just-in-time ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000198

Digital detection of craving and stress for individuals in ... This study aims to 1) categorize experiences with stress and craving during substance use disorder (SUD) treatment, 2) explore perceptions of both clients ...

3. withpower.com withpower.com/trial/phase-2-and-3-substance-use-disorders-sud-3-2022-2b8de

RAE Digital Tool for Substance Use Disorder Research shows that digital tools, like the RAE treatment, have been effective in helping people with opioid use disorder when used alongside medication. These ...

4. researchgate.net researchgate.net/publication/350325062_Realize_Analyze_Engage_RAE_A_Digital_Tool_to_Support_Recovery_from_Substance_Use_Disorder

Realize, Analyze, Engage (RAE): A Digital Tool to Support ... The primary outcome for the RCT will be relapse to substance use at 3, 6, and 12 months · defined as (1) self-reported use of the substance they are in treatment ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547220304839

Leveraging digital tools to support recovery from substance ... Clinicians can use digital health intervention, such as telehealth, wearables, mobile applications, and other remote monitoring devices, to convert in-person ...

6. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-023-00518-1

Digital interventions for substance use disorders in young ... First, two reviewers (MM and MF) independently screened titles and abstracts and assessed studies for inclusion using the Rayyan screening tool ...