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SMART-r: Repositorio de seguimiento de sustancias y seguimiento activo de recaídas

2 de noviembre de 2026 actualizado por: National Institute on Drug Abuse (NIDA)

Background:

About 1.5 million adults in the US enter alcohol or substance use treatment programs each year. Unfortunately, more than half of patients do not finish their program. For those who start treatment, about 70% return to substance use within weeks or months after starting treatment. To discover why patients drop out of treatment and return to substance use - and what can be done about it - researchers need to learn more about people who use drugs and alcohol.

Objective:

To create a data repository by gathering survey and smartphone data from adults who use drugs and alcohol in order to conduct future research.

Eligibility:

Adults who have used drugs or alcohol in the past and have a Android smartphone. The researchers will recruit targeted demographics at different times throughout the duration of the study period.

Design:

Data will be collected for up to 6 months. All research activities will be online.

Participants will download a smartphone app called TTRU-Curtis AWARE and keep it active on their phone. The app will run in the background and collect participant data, including: screen unlocks, duration of time the screen is on; apps used; words typed (except passwords); duration and time of phone calls; estimated location (exact location is not collected); and movement, such as how many steps are taken in a day. All personally identifying information is automatically removed before the data is stored (including phone numbers, names, or locations described in messages).

Each day, participants will receive a text with a link to a survey. They will answer questions about their mood, behavior, and substance use from the day before. This survey should take less than 5 minutes to complete.

Every 30 days, participants will complete a longer survey. They will answer questions about their personal relationships, risky behaviors, mood, substance use, and feelings. They can skip any questions they do not feel comfortable answering. These surveys should take about 30 minutes to complete.

Participants may opt to allow researchers to access their social media posts.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

Description:

This project aims to establish a comprehensive data repository for conducting secondary research, including the analysis of digital phenotype data from individuals who have historically used drugs, including alcohol. Our hypothesis is that digital phenotyping can reveal unique behavioral patterns and risk factors associated with substance use. By collecting data such as smartphone app usage, social media interactions, language data, phone sensor measurements, historical conversational AI data, and wearable device metrics, the TTRU research lab will be able to conduct secondary analyses and uncover insights that could inform prevention and intervention strategies with individuals who use substances.

Objectives

Primary Objective:

The primary objective is to establish the NIDA-IRP Technology and Translational Research Unit (TTRU) Substance Monitoring and Active Relapse Tracking Repository (SMART-r) for collection, storage, and analysis of the human data from individuals who use substances. The secure, high-quality resource of digital, sensor, social media, conversational AI data, self-report, and clinical data (Repository Materials) will be created. Core variables of interest include sensor data, language, and relevant self-report measures. The intention to collect digital phenotyping data is to aid in the efficiency and efficacy of secondary research investigating health outcomes for individuals who use substances by creating a repository of de-identified data.

Tipo de estudio

De observación

Inscripción (Estimado)

10000

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Brenda L Curtis, Ph.D.
  • Número de teléfono: (443) 740-2126
  • Correo electrónico: brenda.curtis@nih.gov

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21224
        • Reclutamiento
        • National Institute on Drug Abuse
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 120 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Adults who have used drugs or alcohol in the past and have a Android smartphone. The researchers will recruit targeted demographics at different times throughout the duration of the study period.

Descripción

  • INCLUSION CRITERIA:

In order to be eligible to participate in the repository, an individual must meet all of the following criteria:

  • Must understand and be willing to complete an online informed consent process.

  • Be an adult aged 18 or older.

  • Self-report alcohol or other drug use within the past 30 days.

  • Have a smartphone as their primary mobile phone.

    --For the AWARE app data monitoring procedure, there may be times during this study period where, due to technical or OS limitations, the app is only available to users of certain devices (e.g., Android, iOS). If there is such a limitation, this information will be evaluated during screening. For example, if the AWARE app is not available for iOS, then the screening form may exclude iPhone users for that time period where the limitation exists, if the only procedures offered are daily diary surveys and AWARE data monitoring.

  • Be willing to adhere to the procedures, such as downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, open-ended survey questions with the TTR Chatbot, uploading historical conversational AI data, and/or follow-up surveys.

  • Understand and write in English.

    --This exclusion criterion is included because future research on the data collected will include linguistic analysis. all linguistic analyses, we remove rare words (e.g., words must be said by at least 95% of participants)95. Additionally, there are cultural differences across languages and, thus, interpreting language results across more than one language becomes difficult.96 As a result, we must keep analysis limited to a single language (English), since words in other languages will not meet that criteria.

  • Live in the United States.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this repository:

1. Any impairment severe enough to preclude informed consent or valid self-report.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: OTHER
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Adults who use substances

Adults 18 years or older who use drugs or alcohol

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
SMARTr data repository
Periodo de tiempo: 20 years

The primary objective is to establish the NIDA-IRP Technology and Translational Research Unit (TTRU) Substance Monitoring and Active Relapse Tracking Repository (SMART-r) for collection, storage, and analysis of the human data from individuals who use substances.

20 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Brenda L Curtis, Ph.D., National Institute on Drug Abuse (NIDA)

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

8 de noviembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2044

Finalización del estudio (Estimado)

31 de diciembre de 2044

Fechas de registro del estudio

Enviado por primera vez

5 de noviembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

5 de noviembre de 2024

Publicado por primera vez (Actual)

6 de noviembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

24 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 10002094
  • 002094-DA

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Only aggregated data will be made available upon request.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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