Smartphone Services for Stimulant Use Disorder

NCT07092059 | Recruiting FDA Device

• 2 other identifiers: DCH003-StUDR44DA059519
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Stimulant Use Disorder

Keywords

cocaine addiction; crack addiction; methamphetamine addiction; cocaine; crack; methamphetamine; stimulants; drug problem; drug addiction; drug abuse

Outcome Measures

Primary Outcomes (1)

• Saliva drug test outcomes

  We will measure if your saliva drug tests show any use of drugs.

  Testing will occur over a 15 month period.

Secondary Outcomes (1)

• Health outcomes

  Assessments will occur over a 15 month period.

Study Arms (2)

DynamiCare Group

EXPERIMENTAL

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.

Device: Smartphone digital therapeutic system

Health & Wellness Group

SHAM COMPARATOR

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.

Device: Smartphone digital therapeutic system

Interventions

Smartphone digital therapeutic system DEVICE

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.

DynamiCare Group; Health & Wellness Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who are at least 18 years old, speak/read English, have a smartphone, and who meet criteria for Stimulant Use Disorder, active or early remission. If being discharged to outpatient or intensive outpatient care, the patient is eligible.

You may not qualify if:

• Unwilling to authorize communication with any treatment provider(s), requiring acute detoxification from alcohol or opioids or residential or hospital treatment, or other obstacle to longitudinal participation in the study.
• Currently pregnant

Sponsors & Collaborators

• DynamiCare Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

This is an At-Home Study - no travel or on-site visits are needed at all; Main Office: 6 Liberty Sq, #2102

Boston, Massachusetts, 02109, United States

RECRUITING

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Carla J Rash, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

• David R Gastfriend, MD

  DynamiCare Health Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David R Gastfriend, MD

CONTACT

860-679-4689; enrollment@dynamicarehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized control trial of a digital therapeutic.

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 29, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

US (1)