Recruiting

Behavioral Approach

Sponsor:

DynamiCare Health

Code:

NCT07092059

Conditions

Stimulant Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smartphone digital therapeutic system

Study Details

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

Study ID

NCT07092059

Start date

Jun 24, 2025

Status verified date

Jul, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DynamiCare Group

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.

sham comparator: Health & Wellness Group

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.

Interventions

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.

Primary outcome measure

  • Saliva drug test outcomes [ Time Frame: Testing will occur over a 15 month period. ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Boston, Massachusetts, United States, 02109

More Information

Sponsor

DynamiCare Health

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by DynamiCare Health on 2025-07-29.