NCT06676059

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
228mo left

Started Apr 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 21, 2026

Expected
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2044

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2044

Last Updated

April 16, 2026

Status Verified

April 10, 2026

Enrollment Period

18.7 years

First QC Date

November 5, 2024

Last Update Submit

April 15, 2026

Conditions

Keywords

AlcoholSubstance usedigital phenotyping

Outcome Measures

Primary Outcomes (1)

  • SMARTr data repository

    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

Study Arms (1)

Adults who use substances

Adults 18 years or older who use drugs or alcohol

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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, uploading historical conversational AI data, and/or follow-up surveys.
  • Understand and write in English.
  • Live in the United States.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (28)

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    PMID: 17565334BACKGROUND
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    PMID: 16670223BACKGROUND
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    PMID: 29973337BACKGROUND
  • Giorgi S, Yaden DB, Eichstaedt JC, Ungar LH, Schwartz HA, Kwarteng A, Curtis B. Predicting U.S. county opioid poisoning mortality from multi-modal social media and psychological self-report data. Sci Rep. 2023 Jun 3;13(1):9027. doi: 10.1038/s41598-023-34468-2.

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  • Meyerhoff J, Liu T, Stamatis CA, Liu T, Wang H, Meng Y, Curtis B, Karr CJ, Sherman G, Ungar LH, Mohr DC. Analyzing text message linguistic features: Do people with depression communicate differently with their close and non-close contacts? Behav Res Ther. 2023 Jul;166:104342. doi: 10.1016/j.brat.2023.104342. Epub 2023 May 27.

    PMID: 37269650BACKGROUND

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Brenda L Curtis, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica E Hemmons

CONTACT

Brenda L Curtis, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 6, 2024

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

December 31, 2044

Study Completion (Estimated)

December 31, 2044

Last Updated

April 16, 2026

Record last verified: 2026-04-10

Data Sharing

IPD Sharing
Will not share

Only aggregated data will be made available upon request.

Locations