Smartphone Services for Stimulant Use Disorder

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
DynamiCare Health
Study ID
NCT07092059
Status
Recruiting
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Conditions

  • Stimulant Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 24, 2025
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
This is an At-Home Study - no travel or on-site visits are needed at all; Main Office: 6 Liberty Sq, #2102BostonMassachusetts02109-

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

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