NCT07092059

Smartphone Services for Stimulant Use Disorder

Decentralized Clinical Trial of Contingency Management Digital Therapeutic to Treat Stimulant Use Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: DynamiCare Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is testing two approaches to treating Stimulant Use Disorder, or problems with cocaine, crack, methamphetamine, etc. Stimulant Use Disorder is a national epidemic in the U.S. but there is no FDA-approved medication to treat it. There is a behavioral approach that has been found to be the most effective treatment for Stimulant Use Disorder, but this study is testing whether this can be delivered by a smartphone service, remotely, such as at home.

Detailed description

We are trying to find out whether one version of a smartphone app is better than another in helping people who have stimulant use disorder. You will not be able to choose which app or app-based services you receive. You will be assigned to one of these two sets of smartphone-based services randomly - like by a flip of a coin. You have a 50/50 chance of receiving either version of the app. You will need to agree to let us speak with your healthcare provider so that we can check this information about you before you start the study. We will also ask you to give us permission to look at how you use your health insurance. We want to learn if you are having visits to a clinic, doctors, Emergency Rooms, or hospitals. This is to learn if people get better and then use fewer healthcare services. We will check this information four times during the study. We will be able to see what treatments you have used, but we won't tell your insurance company that you are in this study. Also, we won't charge anything to your insurance.

Conditions

• Stimulant Use Disorder

Interventions

Type	Name	Description
DEVICE	Smartphone digital therapeutic system	This intervention is composed of a smartphone app (Apple iOS or Android type) that prompts patients with Stimulant Use Disorder to (1) complete self-assessment questionnaires in the app about their health, health care needs and the services they receive and other health-related functions in life, (2) read educational modules about health and wellness and answer questions about these readings, (3) speak periodically with a Guide about their use of the app, and (4) take periodic saliva substance tests using video-selfies with their smartphone camera. The intervention includes testing and interviews with the study staff over a 12 month period. There is a follow-up period to measure the longer-term results at 15 months, as well.

Timeline

• Start date: 2025-06-24
• Primary completion: 2027-05-01
• Completion: 2027-08-01
• First posted: 2025-07-29
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study