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Behavioural Intervention

RAE Digital Tool for Substance Use Disorder

Phase 2 & 3
Waitlist Available
Led By Megan Reinhardt
Research Sponsored by ContinueYou, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Be older than 18 years old
Must not have
Significant limitation of range of motion of non-dominant arm (amputation or fracture)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves monitoring through a smartphone app rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience privacy concerns or emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My non-dominant arm has limited movement due to amputation or fracture.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with return to drug use
Secondary study objectives
Number of hospitalizations and emergency department visits per participant
Number of participants retained in treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional (RAE + Usual Care)Experimental Treatment1 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 Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RAE
2022
Completed Phase 3
~210

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Substance Use Disorder (SUD) include Cognitive-Behavioral Therapy (CBT), Contingency Management (CM), and Motivational Interviewing (MI). CBT helps patients identify and modify negative thought patterns and behaviors associated with substance use, promoting healthier coping strategies. CM uses positive reinforcement, such as vouchers or rewards, to encourage abstinence and adherence to treatment. MI focuses on enhancing a patient's motivation to change by resolving ambivalence and fostering self-efficacy. These treatments are crucial for SUD patients as they address both the psychological and behavioral aspects of addiction, improving treatment adherence and outcomes. The integration of digital biomarker detection can further personalize these interventions by providing real-time data on physiological and behavioral responses, enhancing the effectiveness of these therapies.
Examining differential effects of psychosocial treatments for cocaine dependence: an application of latent trajectory analyses.The capacity for dynamic process scale (CDPS) and patient engagement in opiate addiction treatment.On treatment mechanisms--what can we learn from the COMBINE study?

Find a Location

Who is running the clinical trial?

ContinueYou, LLCLead Sponsor
University of Massachusetts, WorcesterOTHER
361 Previous Clinical Trials
997,007 Total Patients Enrolled
University of Texas at TylerOTHER
3 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

RAE (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05227339 — Phase 2 & 3
Substance Use Disorder Research Study Groups: Interventional (RAE + Usual Care), Control (Usual care)
Substance Use Disorder Clinical Trial 2023: RAE Highlights & Side Effects. Trial Name: NCT05227339 — Phase 2 & 3
RAE (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05227339 — Phase 2 & 3
~58 spots leftby Oct 2025