Recruiting

Observational Study

Sponsor:

National Institute on Drug Abuse (NIDA)

Code:

NCT06676059

Conditions

Alcoholism

Substance-Related Disorders

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Alcoholism

Substance-Related Disorders

Study ID

NCT06676059

Start date

Sep 14, 2026

Status verified date

Jul 15, 2026

Completion date

Dec 31, 2044

Anticipated

Primary completion date

Dec 31, 2044

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults who use substances

Adults 18 years or older who use drugs or alcohol

Primary outcome measure

  • SMARTr data repository [ Time Frame: 20 years ]

Central Contacts and Locations

Central contacts

Jessica E Hemmons

Not Listedjessie.hemmons@nih.gov

Brenda L Curtis, Ph.D.

(443) 740-2126brenda.curtis@nih.gov

Locations

National Institute on Drug Abuse

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Jessie Hemmons

Not Listedsmartrstudy@nih.gov

More Information

Sponsor

National Institute on Drug Abuse (NIDA)

Last update posted

Sep 9, 2026

Last verified

Jul 15, 2026

Keywords

  • Alcohol
  • Substance use
  • digital phenotyping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA) on 2026-09-09.