What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorder include pharmacotherapies such as varenicline, bupropion, topiramate, and naltrexone. Varenicline and bupropion are generally well-tolerated but can cause neuropsychiatric adverse events like anxiety, depression, and agitation, especially in patients with pre-existing mental disorders. Topiramate may lead to adverse effects such as impaired concentration, confusion, dizziness, and anxiety, which can result in higher dropout rates. Naltrexone is considered effective and safe but may cause gastrointestinal issues and liver enzyme abnormalities. Psychosocial interventions, including motivational enhancement therapy and cognitive-behavioral therapy, typically have fewer side effects but require patient engagement and adherence to be effective.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorder. Notable among these are bupropion and naltrexone, which are used in combination to treat alcohol and opioid dependence. Varenicline, primarily approved for smoking cessation, has shown promise in treating cannabis use disorder. Additionally, topiramate has been studied for its potential in reducing cannabis use, although it has not been widely adopted due to adverse effects. These treatments focus on modifying neurotransmitter activity, which aligns with the physiological and behavioral data collection in digital biomarker detection studies.

What other types of research exist?

Promising novel alternatives to digital biomarker detection for SUD patients in 2024 include: 1) Psychedelic-assisted psychotherapy, particularly using substances like psilocybin and MDMA, which have shown efficacy in treating depression and PTSD. 2) Mobile app-based interventions, which leverage technology to provide support and resources for smoking cessation and other substance use behaviors. 3) Cognitive Behavioral Therapy for Insomnia (CBT-I), which can help address underlying sleep issues that often accompany substance use disorders and facilitate the discontinuation of sedative-hypnotic medications.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

0 / 2Eligibility criteria met

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?