跳至主要内容
临床试验/NCT06676059
NCT06676059招募中不适用

SMART-r: Substance Monitoring and Active Relapse Tracking Repository

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
SMARTr data repository

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • 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.

排除标准

  • 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.

研究组 & 干预措施

Adults who use substances

Adults 18 years or older who use drugs or alcohol

结局指标

主要结局

SMARTr data repository

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验