Stimulant Use Disorder
Conditions
Keywords
cocaine addiction, crack addiction, methamphetamine addiction, cocaine, crack, methamphetamine, stimulants, drug problem, drug addiction, drug abuse
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.
Interventions
DEVICESmartphone 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.
Sponsors
National Institute on Drug Abuse (NIDA)
DynamiCare Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a randomized control trial of a digital therapeutic.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Saliva drug test outcomes | Testing will occur over a 15 month period. | We will measure if your saliva drug tests show any use of drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health outcomes | Assessments will occur over a 15 month period. | We will ask you whether or not you are in treatment, whatever healthcare services you use (such as Emergency Room visits, hospital stays), the ways in which you use the app, and about your health and other health functioning. |
Countries
United States
Contacts
Primary ContactDavid R Gastfriend, MD
Outcome results
None listed