Smartphone Services for Stimulant Use Disorder

Официальное название

Decentralized Clinical Trial of Contingency Management Digital Therapeutic to Treat Stimulant Use Disorder

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

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

Вторичные конечные точки (1)

• Health outcomes [Срок оценки: Assessments will occur over a 15 month period.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• This is an At-Home Study - no travel or on-site visits are needed at all; Main Office: 6 L — Boston

Идентификаторы

NCT: NCT07092059 · DCH003-StUD · R44DA059519

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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