Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-28 @ 5:08 PM
Study NCT ID:
NCT07092059
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone Services for Stimulant Use Disorder
Sponsor:
DynamiCare Health
Organization:
Study Overview
Official Title:
Decentralized Clinical Trial of Contingency Management Digital Therapeutic to Treat Stimulant Use Disorder
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44DA059519 | NIH | None | https://reporter.nih.gov/quic… | View |