Substance Use DisordersPhase 2/3NCT05227339
RAE (Realize, Analyze, Engage)
A Phase 2/3 study testing RAE in people with Substance Use Disorders and Treatment Adherence and Compliance, run by ContinueYou, LLC at 1 site in United States.
Trial summary
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Treatment Adherence and Compliance
- What is being tested?
- RAE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2022to 1 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Enrolled in an outpatient SUD treatment program
- Enrolled in treatment for < 90 days
- Fluent in English
- Have access to a smartphone with iOS or Android Capabilities
- Capable of providing informed consent
Who cannot join
- Pregnancy
- Prisoner Status
- Significant limitation of range of motion of non-dominant arm (amputation or fracture)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder
Read the detailed description
RAE integrates digital detection of high-risk stress and craving periods by utilizing a mobile phone application and integrated wearable sensor. These detections are paired with interventions (mindfulness based de-escalation tools), support, and monitoring (to identify trends and plan for future). The present study will deploy the technology in a multi-site randomized controlled trial to test the efficacy of the RAE system in on clinical and psychosocial outcomes. Subjects will be randomized to use the RAE system (mobile app and wearable sensor) plus usual care vs usual care plus a fitness tracker only to measure differences retention in treatment, return to substance use, and overall psychosocial functioning. The ultimate goal is to develop a cost-effective, paradigm changing recovery tool that will improve substance use disorder treatment, and prevent related complications and deaths.
- Being tested
- RAE
- Keywords
- mhealth, stress, craving, wearables, technology, digital diagnostics, digital health
- Medical subject headings
- Substance-Related Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAEDevice
Also called RAE Mobile App
Subjects in the interventional group will have access to the RAE Health mobile app which receives continuous physiologic data from a wearable device. Algorithms embedded in the RAE app detect stress and craving events, and trigger mobile phone notifications when detected. Notifications are paired to real-time mindfulness based interventions.
| Study group | Role | What they receive |
|---|---|---|
| Interventional (RAE + Usual Care) | Experimental | 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. Receives: Device: RAE |
| Control (Usual care) | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with return to drug use
Relapse to use of substance use defined as 1) self-reported use, 2) positive urine drug screen (from treatment program) or 3) provider report of confirmed relapse (Only applies to substances for which subject is receiving treatment)
Measured: 3 months
Secondary outcomes (2)
Number of participants retained in treatment
Participants status as engaged in recovery treatment (index treatment program or other)
Measured: 3 months
Number of hospitalizations and emergency department visits per participant
Includes absolute number of Emergency Department visits (SUD and non-SUD related), number of unplanned hospital admissions (SUD and non-SUD related), number of days hospitalized (SUD and non-SUD related admissions) and overdose related visits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start22 Feb 2022
- Primary completion1 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContinueYou, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester, University of Texas at Tyler
- Responsible party
- Sponsor
- Investigators
- Megan Reinhardt, Principal investigator, ContinueYou, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227339
- Sponsor's protocol ID
- RAEPHASEII
- Status last verified
- Jul 2024
- First submitted
- 25 Jan 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Carreiro S, Taylor M, Shrestha S, Reinhardt M, Gilbertson N, Indic P. Realize, Analyze, Engage (RAE): A Digital Tool to Support Recovery from Substance Use Disorder. J Psychiatr Brain Sci. 2021;6:e210002. doi: 10.20900/jpbs.20210002. Epub 2021 Feb 24.
PubMed 33748430Carreiro S, Chintha KK, Shrestha S, Chapman B, Smelson D, Indic P. Wearable sensor-based detection of stress and craving in patients during treatment for substance use disorder: A mixed methods pilot study. Drug Alcohol Depend. 2020 Apr 1;209:107929. doi: 10.1016/j.drugalcdep.2020.107929. Epub 2020 Mar 3.
PubMed 32193048
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAE (Realize, Analyze, Engage)- A Digital Biomarker Based Detection and Intervention System for Stress and Craving During Recovery From Substance Use Disorder: Phase II
- ClinicalTrials.gov ID
- NCT05227339
- Acronym / sponsor ID
- RAEPHASEII
- Keywords
- mhealth, stress, craving, wearables, technology, digital diagnostics, digital health
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- ContinueYou, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Massachusetts, Worcester, University of Texas at Tyler
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will evaluate the detection of digital biomarkers of stress, and drug craving in a population of individuals undergoing treatment for substance use disorder
Detailed description
RAE integrates digital detection of high-risk stress and craving periods by utilizing a mobile phone application and integrated wearable sensor. These detections are paired with interventions (mindfulness based de-escalation tools), support, and monitoring (to identify trends and plan for future). The present study will deploy the technology in a multi-site randomized controlled trial to test the efficacy of the RAE system in on clinical and psychosocial outcomes. Subjects will be randomized to use the RAE system (mobile app and wearable sensor) plus usual care vs usual care plus a fitness tracker only to measure differences retention in treatment, return to substance use, and overall psychosocial functioning. The ultimate goal is to develop a cost-effective, paradigm changing recovery tool that will improve substance use disorder treatment, and prevent related complications and deaths.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional (RAE + Usual Care) | Experimental | Device: RAESubjects 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. |
| Control (Usual care) | No 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Enrolled in an outpatient SUD treatment program
- Enrolled in treatment for < 90 days
- Fluent in English
- Have access to a smartphone with iOS or Android Capabilities
Key exclusion criteria (3 listed)
- Pregnancy
- Prisoner Status
- Significant limitation of range of motion of non-dominant arm (amputation or fracture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAEAlso: RAE Mobile AppSubjects in the interventional group will have access to the RAE Health mobile app which receives continuous physiologic data from a wearable device. Algorithms embedded in the RAE app detect stress and craving events, and trigger mobile phone notifications when detected. Notifications are paired to real-time mindfulness based interventions. | Device | Interventional (RAE + Usual Care) |
Primary outcome
Number of participants with return to drug use
Time frame: 3 months
Relapse to use of substance use defined as 1) self-reported use, 2) positive urine drug screen (from treatment program) or 3) provider report of confirmed relapse (Only applies to substances for which subject is receiving treatment)
2 secondary outcomes
Number of participants retained in treatment
Time frame: 3 months
Number of hospitalizations and emergency department visits per participant
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 33748430Carreiro S, Taylor M, Shrestha S, Reinhardt M, Gilbertson N, Indic P. Realize, Analyze, Engage (RAE): A Digital Tool to Support Recovery from Substance Use Disorder. J Psychiatr Brain Sci. 2021;6:e210002. doi: 10.20900/jpbs.20210002. Epub 2021 Feb 24.
- Background: PubMed 32193048Carreiro S, Chintha KK, Shrestha S, Chapman B, Smelson D, Indic P. Wearable sensor-based detection of stress and craving in patients during treatment for substance use disorder: A mixed methods pilot study. Drug Alcohol Depend. 2020 Apr 1;209:107929. doi: 10.1016/j.drugalcdep.2020.107929. Epub 2020 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Reinhardt principal investigator
ContinueYou, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RAE in people with Substance Use Disorders and Treatment Adherence and Compliance, run by ContinueYou, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with return to drug use (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227339, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.