DynamiCare + Patient Navigation for Stimulant Use Disorder

(RESTORE Trial)

Not yet recruiting at 1 trial location

Overseen By Ank Nijhawan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Severe disability, Unable to consent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist individuals recently released from jail or prison who struggle with stimulant use (such as meth or cocaine) and are at risk for or living with HIV. It combines a mobile app called DynamiCare, which supports behavior change, with patient navigation—a service that guides patients through healthcare systems—to improve HIV-related care and reduce drug use. The trial compares two groups: one using the app and another receiving standard support without it. Ideal candidates for this trial have a stimulant use disorder and are transitioning back to the community from a justice setting. Participants should be comfortable using a smartphone app for this study.

As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for improving health outcomes in vulnerable populations.

Will I have to stop taking my current medications?

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 healthcare provider.

What prior data suggests that the DynamiCare app is safe for use in justice-involved individuals?

Research has shown that the DynamiCare mobile app, which uses a reward-based treatment to help reduce stimulant use, delivers promising results. The FDA has approved the app, confirming it has passed strict safety checks for its intended use.

Previous studies found that technology like DynamiCare can help people stay in treatment longer and reduce their use of drugs like cocaine. These studies did not identify any major safety issues with the app.

Overall, evidence suggests that DynamiCare is user-friendly, and no serious side effects were reported in these studies. This makes it a potentially safe choice for those considering joining this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DynamiCare treatment for stimulant use disorder because it leverages a smartphone app to deliver contingency management, which is a novel approach compared to traditional therapies. Unlike conventional treatments that often rely on behavioral therapy and medication, DynamiCare uses a mobile app to offer rewards for positive behavior changes, such as attending therapy sessions or maintaining sobriety. This tech-driven approach is more engaging and accessible, potentially increasing adherence and success rates. Additionally, by integrating patient navigation with a digital platform, DynamiCare offers a comprehensive and personalized support system, making it distinct from standard care options.

What evidence suggests that DynamiCare-plus could be effective for stimulant use disorder?

Research has shown that contingency management (CM) is the most effective method to reduce stimulant use. In this trial, participants in one arm will use DynamiCare, a mobile app that employs CM and has significantly increased the chances of quitting stimulants, with studies showing a 2-4 times higher success rate. The app integrates easily with other community treatment programs due to its digital nature. Although the effects of DynamiCare on HIV-related outcomes remain unknown, its success in reducing stimulant use suggests potential benefits for overall health in those with stimulant use disorder. Another arm of this trial will involve Enhanced Treatment as Usual (ETAU), which includes Patient Navigation without the DynamiCare app. ^{1 3 4 6 7}

Who Is on the Research Team?

Ank Nijhawan, MD

Principal Investigator

University of Texas Southwestern Medical Center

Sandra Springer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

The RESTORE study is for individuals recently released from justice settings who struggle with stimulant use disorder and are at risk for or living with HIV/AIDS. It aims to help them start and stick to HIV treatment/prevention plans like ART and PrEP, while also reducing their stimulant use.

Inclusion Criteria

Be at risk for or living with HIV

Have a DSM-5 diagnosis of stimulant use disorder (methamphetamine and/or cocaine)

I am 18 years old or older.

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe

I am unable to understand or agree to the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either DynamiCare-plus or Enhanced Treatment as Usual (ETAU) for a 6-month intervention period

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

R33 Phase

If milestones are met, the trial will scale to a randomized controlled trial with 252 participants to assess effectiveness, implementation, and cost over a 12-month intervention period

12 months

What Are the Treatments Tested in This Trial?

Interventions

• DynamiCare
• Patient Navigation

Trial Overview This trial tests a combination of DynamiCare (an FDA-approved app that supports recovery from drug use) with patient navigation services. The goal is to see if this combo helps participants better manage their HIV treatment/prevention and reduce stimulant consumption.

How Is the Trial Designed?

Group I: Arm 1: DynamiCare-plus Experimental Treatment 2 Interventions

Patient Navigation (PN) with a smartphone with the DynamiCare mobile contingency management app

Group II: Arm 2: Enhanced Treatment as Usual (ETAU) Active Control 1 Intervention

Patient Navigation (PN) with a smartphone without the DynamiCare app

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. dynamicarehealth.com dynamicarehealth.com/our-results

Our Results — DynamiCare Health DynamiCare has collaborated with leading academic institutions to conduct clinical studies on DynamiCare, which have demonstrated a 2-4x increase in quit rates.

2. dynamicarehealth.com dynamicarehealth.com/contingency-management-for-stimulant-use

Contingency management for stimulant use In an extensive meta-analysis from PLOS Medicine, we see clinical outcomes from 50 studies on cocaine and stimulant use. Results consistently show a reduction ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8197772/

Digital delivery of a contingency management intervention ... These data suggest that DynamiCare Health is feasible and potentially beneficial as a complement to community substance use treatment programs.

4. 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 ...

5. dynamicarehealth.com dynamicarehealth.com/cm-reports

Contingency Management Reports — DynamiCare Health The following free reports have been developed by DynamiCare and are being provided to the public for education on the contingency management model.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12263680/

Digitally delivered contingency management during ... Our overarching hypothesis is that participants in the TAU+DCM arm will have longer treatment retention, lower rates of opioid and cocaine use, ...

7. health.ny.gov health.ny.gov/health_care/medicaid/ebbrac/2025/docs/2025-04-02_contingency_mgmt_sud_rpt.pdf

Contingency Management for Stimulant Use Disorder Health ... Of these, 2 trials from DynamiCare are exploring the use of a mobile application ... evidence/urine drug test, entering the results into the mobile or web-based ...