Smartphone Services for Drug Addiction

Overseen By David R Gastfriend, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DynamiCare Health

Disqualifiers: Pregnancy, Alcohol detox, Opioid detox, others

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

Compensation: Varies

Number of Visits: 2

Duration: 15 months

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to assist individuals with Stimulant Use Disorder, which involves issues with drugs like cocaine and methamphetamine. The study tests a smartphone digital therapeutic system, a smartphone app that allows users to take video selfies of saliva drug tests and access therapy and wellness resources. One group will use the app with therapy modules, while another group will receive general health information. Individuals with a smartphone who are dealing with Stimulant Use Disorder, whether currently or in early recovery, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future treatments for Stimulant Use Disorder.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this smartphone digital therapeutic system is safe for treating Stimulant Use Disorder?

Research has shown that smartphone apps can safely assist with substance use problems. Some studies have found that these apps aid recovery by keeping users engaged and helping them track their progress. When combined with other treatments, a digital therapeutic app has improved patient outcomes in certain cases.

While researchers continue to study the overall safety of smartphone apps for treating substance use disorders, they are generally considered low-risk. Main features, such as taking video selfies for drug tests and using self-guided therapy, do not cause physical side effects. However, not all apps have proven effective, and more research is needed to confirm their benefits for stimulant use disorder specifically. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the smartphone digital therapeutic system for drug addiction because it offers a novel approach to recovery using technology. Unlike traditional treatments that often rely on in-person therapy and medication, this system leverages a smartphone app to deliver self-guided cognitive behavioral therapy (CBT) modules and allows for secure video-based drug testing. The app also facilitates data sharing with healthcare providers and support networks, making it a more interactive and accessible option for users. This method not only enhances privacy and convenience but also empowers users to engage actively in their recovery process.

What evidence suggests that this smartphone digital therapeutic system is effective for treating Stimulant Use Disorder?

Research has shown that digital tools, like smartphone apps, can help manage substance use problems. In this trial, participants will join one of two groups using smartphone apps. The DynamiCare Group will use an app with features such as video selfies for drug tests, self-guided CBT therapy modules, and appointment tracking, which may improve treatment outcomes. The Health & Wellness Group will use a similar app focused on health and wellness information. Although limited data exists on the effectiveness of phone apps specifically for stimulant addiction, digital treatments have shown promise for various mental health and substance use issues. These apps aim to help individuals adhere to their therapy, even from home. ^{2 3 5 6 7}

Who Is on the Research Team?

Carla J Rash, PhD

Principal Investigator

UConn Health

David R Gastfriend, MD

Principal Investigator

DynamiCare Health Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak/read English, have a smartphone, and are diagnosed with Stimulant Use Disorder (active or early remission). It's suitable for those transitioning to outpatient care. People not meeting these criteria cannot participate.

Inclusion Criteria

I am 18 or older, speak English, have a smartphone, and am diagnosed with Stimulant Use Disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants use a smartphone app for recovery, including video selfies for saliva drug tests and self-assessments

15 months

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone digital therapeutic system

Trial Overview The study examines if a behavioral treatment for Stimulant Use Disorder can be effectively delivered through a smartphone service. This could allow patients to receive therapy remotely, such as at home.

How Is the Trial Designed?

Group I: DynamiCare Group Experimental Treatment 1 Intervention

The main thing participants will do is use an app on their smartphone that might help with recovery. The most important feature of the app is that it allows participants to take a video selfie of themselves taking saliva (spit) drug tests. Then, the app will send these videos to the investigators in a way that is secure and protected. The app also has self-assessments \& reading materials that may be of interest to participants. The intervention group will have an appointment and call tracking module and self-guided CBT therapy modules. The DynamiCare group will be able to report the data collected to their providers and will be able to share the app with people who support them.

Group II: Health & Wellness Group Placebo Group 1 Intervention

The main thing participants will do is use an app on their smartphone that might help with their recovery. The most important feature of the app is that it allows participants to take a video selfie of themselves taking saliva (spit) drug tests. Then, the app will send these videos to the investigators in a way that is secure and protected. The app also has self-assessments \& reading materials or modules that may be of interest to participants. The control group will have health and wellness information modules.

Who Is Running the Clinical Trial?

DynamiCare Health

Lead Sponsor

Trials

4

Recruited

510+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7134325/

The past, current, and future role of the National Drug Abuse ... The application of digital technologies to better assess, understand, and treat substance use disorders (SUDs) is a particularly promising and vibrant area ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827185

Smartphone App–Based Contingency Management and ... These findings suggest that adding app-based contingency management to MOUD is associated with better treatment outcomes in clinical settings.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07092059

Smartphone Services for Stimulant Use Disorder This study is testing two approaches to treating Stimulant Use Disorder, or problems with cocaine, crack, methamphetamine, etc. Stimulant Use Disorder is a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S294976122400021X

Review Therapeutic Content of Mobile Phone Applications ... This meta-analytical umbrella review of reviews shows there are insufficient data to assert that MPAs, in total, significantly improve SUD-related outcomes.

5. library.samhsa.gov library.samhsa.gov/sites/default/files/pep23-06-00-001.pdf

Digital Therapeutics for Management and Treatment in ... DTx can be effective independent or complementary services in the management and treatment of mental health conditions and substance use disorders. ○ Users ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8666102/

Safety and efficacy of a prescription digital therapeutic as ... A prescription digital therapeutic in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit ...

7. beonbrand.getbynder.com beonbrand.getbynder.com/m/bb191994b6e1f66b/original/Digital-Therapeutic-Products-for-Substance-Use-Disorders.pdf

Digital Therapeutic Products for Substance Use Disorders A secondary analysis of data from the trial reported an association between engagement with the app and abstinence at 9 to 12 weeks, but study ...