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

209 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new system that uses a smartphone app and wearable device to help people in substance use disorder treatment manage stress and cravings. It aims to improve their treatment outcomes by providing calming tools and support.

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 data supports the effectiveness of the RAE treatment 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 tools are designed to support treatment by providing additional resources and tracking progress, which can improve outcomes for patients. ^{1 2 3 4 5}

What makes the RAE treatment unique for substance use disorder?

The RAE treatment is unique because it is a digital tool that uses real-time data to detect high-risk events like stress and drug cravings, providing immediate support to help prevent relapse. This approach is different from traditional treatments that may not offer such timely interventions. ^{1 6 7 8 9}

Research Team

Megan Reinhardt

Principal Investigator

ContinueYou, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

2. England pubmed.ncbi.nlm.nih.gov

An instrument for assessing progress in substance use disorder treatment: a pilot study of initial reliability and factor structure of the Treatment Progress Assessment-8. [2021]

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

The Treatment Effectiveness Assessment (TEA): an efficient, patient-centered instrument for evaluating progress in recovery from addiction. [2021]

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

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]

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

Reliability and validity of the substance abuse outcomes module. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Realize, Analyze, Engage (RAE): A Digital Tool to Support Recovery from Substance Use Disorder. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Help for Substance Users (SU): A Systematic Review. [2023]

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

Computer-based interventions for drug use disorders: a systematic review. [2022]