Smartphone Services for Stimulant Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smartphone digital therapeutic system.
- Who it may be relevant to
- Registry conditions: Stimulant Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Decentralized Clinical Trial of Contingency Management Digital Therapeutic to Treat Stimulant Use Disorder
Overview
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.
Interventions
- 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 t
Primary outcome measures
- Saliva drug test outcomes [Time frame: Testing will occur over a 15 month period.]
Secondary outcome measures (1)
- Health outcomes [Time frame: Assessments will occur over a 15 month period.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- This is an At-Home Study - no travel or on-site visits are needed at all; Main Office: 6 L — Boston
Identifiers
NCT: NCT07092059 · DCH003-StUD · R44DA059519