Clinical trial NCT06676059: SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Official title: SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcoholism
Substance-Related Disorders
Keywords: Alcohol
Substance use
digital phenotyping
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-11-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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, phone sensor measurements, 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, 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.

Eligibility criteria: * 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 an Android smartphone as their primary mobile phone.

  --The TTRU-CURTIS AWARE App does not have iPhone iOS functionality.
* Have a minimum of 500 sent text messages and 1000 words exchanged through SMS (text messages).
* Be willing to adhere to the procedures, including downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, and 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. 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:

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

Primary outcomes:
measure: SMARTr data repository
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Drug Abuse
state: Maryland
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Brenda L Curtis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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