AlcoholismNCT06676059
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
An observational study of Alcoholism and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Alcoholism, Substance-Related Disorders
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 31 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute on Drug Abuse
Baltimore, Maryland, 21224
Jessie Hemmons, Not Listed, smartrstudy@nih.gov
About this study
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.
Read more
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.
Read the 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, 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.
- Conditions
- Alcoholism, Substance-Related Disorders
- Keywords
- Alcohol, Substance use, digital phenotyping
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults who use substances | Adults 18 years or older who use drugs or alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start29 Oct 2026 (estimated)
- Primary completion31 Dec 2044 (estimated)
- Study completion31 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brenda L Curtis, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676059
- Sponsor's protocol ID
- 10002094
- Other IDs
- 002094-DA
- Status last verified
- 21 Oct 2026
- First submitted
- 5 Nov 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be made available upon request.
Publications
Sinha R. New findings on biological factors predicting addiction relapse vulnerability. Curr Psychiatry Rep. 2011 Oct;13(5):398-405. doi: 10.1007/s11920-011-0224-0.
PubMed 21792580Bauer LO. Predicting relapse to alcohol and drug abuse via quantitative electroencephalography. Neuropsychopharmacology. 2001 Sep;25(3):332-40. doi: 10.1016/S0893-133X(01)00236-6.
PubMed 11522462Claus RE, Kindleberger LR. Engaging substance abusers after centralized assessment: predictors of treatment entry and dropout. J Psychoactive Drugs. 2002 Jan-Mar;34(1):25-31. doi: 10.1080/02791072.2002.10399933.
PubMed 12003110Darke S, Campbell G, Popple G. Retention, early dropout and treatment completion among therapeutic community admissions. Drug Alcohol Rev. 2012 Jan;31(1):64-71. doi: 10.1111/j.1465-3362.2011.00298.x. Epub 2011 Mar 22.
PubMed 21426420Evans E, Li L, Hser YI. Client and program factors associated with dropout from court mandated drug treatment. Eval Program Plann. 2009 Aug;32(3):204-12. doi: 10.1016/j.evalprogplan.2008.12.003. Epub 2008 Dec 11.
PubMed 19150133Lejuez CW, Zvolensky MJ, Daughters SB, Bornovalova MA, Paulson A, Tull MT, Ettinger K, Otto MW. Anxiety sensitivity: a unique predictor of dropout among inner-city heroin and crack/cocaine users in residential substance use treatment. Behav Res Ther. 2008 Jul;46(7):811-8. doi: 10.1016/j.brat.2008.03.010. Epub 2008 Mar 28.
PubMed 18466878Lopez-Goni JJ, Fernandez-Montalvo J, Arteaga A. Addiction treatment dropout: exploring patients' characteristics. Am J Addict. 2012 Jan-Feb;21(1):78-85. doi: 10.1111/j.1521-0391.2011.00188.x. Epub 2011 Dec 1.
PubMed 22211350Odenwald M, Semrau P. Dropout among patients in qualified alcohol detoxification treatment: the effect of treatment motivation is moderated by Trauma Load. Subst Abuse Treat Prev Policy. 2013 Mar 21;8:14. doi: 10.1186/1747-597X-8-14.
PubMed 23514277Epstein DH, Marrone GF, Heishman SJ, Schmittner J, Preston KL. Tobacco, cocaine, and heroin: Craving and use during daily life. Addict Behav. 2010 Apr;35(4):318-24. doi: 10.1016/j.addbeh.2009.11.003. Epub 2009 Nov 12.
PubMed 19939575Epstein DH, Willner-Reid J, Vahabzadeh M, Mezghanni M, Lin JL, Preston KL. Real-time electronic diary reports of cue exposure and mood in the hours before cocaine and heroin craving and use. Arch Gen Psychiatry. 2009 Jan;66(1):88-94. doi: 10.1001/archgenpsychiatry.2008.509.
PubMed 19124692Preston KL, Vahabzadeh M, Schmittner J, Lin JL, Gorelick DA, Epstein DH. Cocaine craving and use during daily life. Psychopharmacology (Berl). 2009 Dec;207(2):291-301. doi: 10.1007/s00213-009-1655-8. Epub 2009 Sep 24.
PubMed 19777216Koob G, Kreek MJ. Stress, dysregulation of drug reward pathways, and the transition to drug dependence. Am J Psychiatry. 2007 Aug;164(8):1149-59. doi: 10.1176/appi.ajp.2007.05030503.
PubMed 17671276McHugh RK. Treatment of co-occurring anxiety disorders and substance use disorders. Harv Rev Psychiatry. 2015 Mar-Apr;23(2):99-111. doi: 10.1097/HRP.0000000000000058.
PubMed 25747923Berenz EC, Coffey SF. Treatment of co-occurring posttraumatic stress disorder and substance use disorders. Curr Psychiatry Rep. 2012 Oct;14(5):469-77. doi: 10.1007/s11920-012-0300-0.
PubMed 22825992Crosby R, Holtgrave DR, Stall R, Peterson JL, Shouse L. Differences in HIV risk behaviors among black and white men who have sex with men. Sex Transm Dis. 2007 Oct;34(10):744-8. doi: 10.1097/OLQ.0b013e31804f81de.
PubMed 17565334
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART-r: Substance Monitoring and Active Relapse Tracking Repository
- ClinicalTrials.gov ID
- NCT06676059
- Acronym / sponsor ID
- 10002094
- Conditions
- Alcoholism, Substance-Related Disorders
- Keywords
- Alcohol, Substance use, digital phenotyping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2044 (estimated)
- Study completion
- 31 Dec 2044 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults who use substances | – | –Adults 18 years or older who use drugs or alcohol |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SMARTr data repository
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 21792580Sinha R. New findings on biological factors predicting addiction relapse vulnerability. Curr Psychiatry Rep. 2011 Oct;13(5):398-405. doi: 10.1007/s11920-011-0224-0.
- Background: PubMed 11522462Bauer LO. Predicting relapse to alcohol and drug abuse via quantitative electroencephalography. Neuropsychopharmacology. 2001 Sep;25(3):332-40. doi: 10.1016/S0893-133X(01)00236-6.
- Background: PubMed 12003110Claus RE, Kindleberger LR. Engaging substance abusers after centralized assessment: predictors of treatment entry and dropout. J Psychoactive Drugs. 2002 Jan-Mar;34(1):25-31. doi: 10.1080/02791072.2002.10399933.
- Background: PubMed 21426420Darke S, Campbell G, Popple G. Retention, early dropout and treatment completion among therapeutic community admissions. Drug Alcohol Rev. 2012 Jan;31(1):64-71. doi: 10.1111/j.1465-3362.2011.00298.x. Epub 2011 Mar 22.
- Background: PubMed 19150133Evans E, Li L, Hser YI. Client and program factors associated with dropout from court mandated drug treatment. Eval Program Plann. 2009 Aug;32(3):204-12. doi: 10.1016/j.evalprogplan.2008.12.003. Epub 2008 Dec 11.
- Background: PubMed 18466878Lejuez CW, Zvolensky MJ, Daughters SB, Bornovalova MA, Paulson A, Tull MT, Ettinger K, Otto MW. Anxiety sensitivity: a unique predictor of dropout among inner-city heroin and crack/cocaine users in residential substance use treatment. Behav Res Ther. 2008 Jul;46(7):811-8. doi: 10.1016/j.brat.2008.03.010. Epub 2008 Mar 28.
- Background: PubMed 22211350Lopez-Goni JJ, Fernandez-Montalvo J, Arteaga A. Addiction treatment dropout: exploring patients' characteristics. Am J Addict. 2012 Jan-Feb;21(1):78-85. doi: 10.1111/j.1521-0391.2011.00188.x. Epub 2011 Dec 1.
- Background: PubMed 23514277Odenwald M, Semrau P. Dropout among patients in qualified alcohol detoxification treatment: the effect of treatment motivation is moderated by Trauma Load. Subst Abuse Treat Prev Policy. 2013 Mar 21;8:14. doi: 10.1186/1747-597X-8-14.
- Background: PubMed 19939575Epstein DH, Marrone GF, Heishman SJ, Schmittner J, Preston KL. Tobacco, cocaine, and heroin: Craving and use during daily life. Addict Behav. 2010 Apr;35(4):318-24. doi: 10.1016/j.addbeh.2009.11.003. Epub 2009 Nov 12.
- Background: PubMed 19124692Epstein DH, Willner-Reid J, Vahabzadeh M, Mezghanni M, Lin JL, Preston KL. Real-time electronic diary reports of cue exposure and mood in the hours before cocaine and heroin craving and use. Arch Gen Psychiatry. 2009 Jan;66(1):88-94. doi: 10.1001/archgenpsychiatry.2008.509.
- Background: PubMed 19777216Preston KL, Vahabzadeh M, Schmittner J, Lin JL, Gorelick DA, Epstein DH. Cocaine craving and use during daily life. Psychopharmacology (Berl). 2009 Dec;207(2):291-301. doi: 10.1007/s00213-009-1655-8. Epub 2009 Sep 24.
- Background: PubMed 17671276Koob G, Kreek MJ. Stress, dysregulation of drug reward pathways, and the transition to drug dependence. Am J Psychiatry. 2007 Aug;164(8):1149-59. doi: 10.1176/appi.ajp.2007.05030503.
- Individual participant dataSharing planned: No. Only aggregated data will be made available upon request.
Related trials for Alcoholism
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingPhase 1
Spironolactone in Alcohol Use Disorder (SAUD)
Alcohol Use Disorder
Not yet recruiting
Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brenda L Curtis, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica E Hemmons (Not Listed, jessie.hemmons@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMARTr data repository (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676059, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.