Alcohol Use DisorderSTARNCT07573540
Optimizing Smart Technology for Addiction Recovery
A study testing STAR in people with Alcohol Use Disorder and Alcohol Use Disorder (AUD), run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to: help people to improve their health make changes in people's lives to address alcohol and substance use Participants will: complete surveys use a recovery-support… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Use Disorder (AUD)
- What is being tested?
- STAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 31 Jul 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet criteria for alcohol use disorder with at least moderate severity (>= 4 DSM-5 criteria)
- in initial remission with most recent use of alcohol between 1 week and 3 months in the past
- able to read English
- have a smartphone and cellular plan that supports STAR use (Apple iOS or Android)
Who cannot join
- medical or psychiatric co-morbidities that preclude use of a smartphone
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
University of Wisconsin
Madison, Wisconsin, 53706
About this study
Official title: Optimizing Algorithmic Feedback About Lapse Risk for Trust, Engagement, and Clinical Outcomes for Alcohol Use Disorder
The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to:
- help people to improve their health
- make changes in people's lives to address alcohol and substance use
Participants will:
- complete surveys
- use a recovery-support digital therapeutic system
Read the detailed description
This study seeks to optimize messaging components which can be implemented in a recovery support messaging system such as may accompany a digital therapeutic app, in order to determine optimal messaging to increase interaction with recovery support resources, and whether messaging has any effect on clinical outcomes.
- Conditions
- Alcohol Use Disorder, Alcohol Use Disorder (AUD)
- Being tested
- STAR
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARDevice
Also called Smart Technology for Addiction Recovery
Automated recovery support messaging system for participants with alcohol use disorder (AUD), paired with a machine learning guided relapse risk prediction model.
| Study group | Role | What they receive |
|---|---|---|
| STAR | Experimental | Participants will use the STAR automated recover support system for 4 months Receives: Device: STAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant engagement with the STAR system
Measured as days of engagement with the recovery system.
Measured: data collected at 2 and 4 months
Secondary outcomes (10)
Number of heavy drinking days in the previous 28 days
Data collected via Timeline Followback (TLFB) conducted by interview at 0, 2, and 4 months. Ecological Momentary Assessment (EMA) lapse reports will be used to supplement the TLFB. These are daily surveys where the participant answers the question "have you had a drink you have not yet reported?" (Yes/No). If yes they are asked to indicate the date of their drinking and how many drinks they consumed that day (less than 1, 1-2, 3, 4, 5-6, 7-8, over 8). Four or more drinks are considered heavy drinking days for women and greater than 4 drinks are considered heavy drinking days for men.
Measured: data collected at baseline, 2, 4 months
Number of drinking days in the previous 28 days
Data collected via Timeline Followback (TLFB) conducted by interview at 0, 2, and 4 months. EMA lapse reports will be used to supplement the TLFB. These are daily surveys where the participant answers the question "have you had a drink you have not yet reported?" (Yes/No). If yes, they are asked to indicate the date of their drinking.
Measured: data collected at baseline, 2, 4 months
Flourishing Scale Score
10 items rated on 0-10 Likert scale where lower scores represent worse functioning and higher scores represent better functioning. Total possible range of scores is from 0-100.
Measured: data collected at baseline, 2, 4 months
Generalized Anxiety Disorder-7 (GAD-7) Score
7 items rated on 0-3 Likert scale where lower scores represent better functioning and higher scores represent worse functioning. Total possible range of scores is from 0-21.
Measured: data collected at baseline, 2, 4 months
Multidimensional Inventory of Recovery Capital (MIRC) Score: Total Score
1-4 Likert scale. Some items are reverse coded but higher total scores represent better functioning and lower total scores represent worse functioning. Scored as total score 4-56.
Measured: data collected at baseline, 2, 4 months
Multidimensional Inventory of Recovery Capital (MIRC) Score: Each Domain
1-4 Likert scale. Some items are reverse coded but higher total scores represent better functioning and lower total scores represent worse functioning. Scored in 4 domains (social, physical, human, and cultural), each from 1-14.
Measured: data collected at baseline, 2, 4 months
Patient Health Questionnaire (PQH-9) Score
9 items rated on 1-4 Likert scale. Total possible range of scores from 0-27 where lower scores represent better functioning and higher scores represent worse functioning.
Measured: data collected at baseline, 2, 4 months
Digital Working Alliance Inventory (D-WAI)
Six items rated on 1-7 Likert scale. Scored in 3 domains (Goals, Tasks, Bonds, each with 2 items) with possible scores from 2 to 14 where higher scores represent greater alliance with the STAR system in that domain.
Measured: data collected at 2 and 4 months
Message Usefulness
Seven items rated on 1-7 Likert scale. Total possible scores from 7 to 49 where higher scores represent greater valuation of STAR message usefulness.
Measured: data collected at 2 and 4 months
Trust of the System
Ten items rated on 1-7 Likert scale. Total possible scores from 10 to 70 where higher scores represent greater trust in the STAR system.
Measured: data collected at 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start24 Sep 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- John Curtin, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573540
- Sponsor's protocol ID
- 2024-0869
- Other IDs
- 1R01AA031762-01, A487400, Protocol Version 4/22/2026
- Acronym
- STAR
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Algorithmic Feedback About Lapse Risk for Trust, Engagement, and Clinical Outcomes for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07573540
- Acronym / sponsor ID
- STAR / 2024-0869
- Conditions
- Alcohol Use Disorder, Alcohol Use Disorder (AUD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 7 May 2026 (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.
The goal of this study is to develop a machine-learning guided recovery messaging system. The main question it aims to answer is can messages be used to:
- help people to improve their health
- make changes in people's lives to address alcohol and substance use
Participants will:
- complete surveys
- use a recovery-support digital therapeutic system
Detailed description
This study seeks to optimize messaging components which can be implemented in a recovery support messaging system such as may accompany a digital therapeutic app, in order to determine optimal messaging to increase interaction with recovery support resources, and whether messaging has any effect on clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STAR | Experimental | Device: STARParticipants will use the STAR automated recover support system for 4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meet criteria for alcohol use disorder with at least moderate severity (>= 4 DSM-5 criteria)
- in initial remission with most recent use of alcohol between 1 week and 3 months in the past
- able to read English
- have a smartphone and cellular plan that supports STAR use (Apple iOS or Android)
Key exclusion criteria (1 listed)
- medical or psychiatric co-morbidities that preclude use of a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARAlso: Smart Technology for Addiction RecoveryAutomated recovery support messaging system for participants with alcohol use disorder (AUD), paired with a machine learning guided relapse risk prediction model. | Device | STAR |
Primary outcome
Participant engagement with the STAR system
Time frame: data collected at 2 and 4 months
Measured as days of engagement with the recovery system.
10 secondary outcomes
Number of heavy drinking days in the previous 28 days
Time frame: data collected at baseline, 2, 4 months
Number of drinking days in the previous 28 days
Time frame: data collected at baseline, 2, 4 months
Flourishing Scale Score
Time frame: data collected at baseline, 2, 4 months
Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: data collected at baseline, 2, 4 months
Multidimensional Inventory of Recovery Capital (MIRC) Score: Total Score
Time frame: data collected at baseline, 2, 4 months
Multidimensional Inventory of Recovery Capital (MIRC) Score: Each Domain
Time frame: data collected at baseline, 2, 4 months
Patient Health Questionnaire (PQH-9) Score
Time frame: data collected at baseline, 2, 4 months
Digital Working Alliance Inventory (D-WAI)
Time frame: data collected at 2 and 4 months
Message Usefulness
Time frame: data collected at 2 and 4 months
Trust of the System
Time frame: data collected at 2 and 4 months
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 25 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
John Curtin, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR in people with Alcohol Use Disorder and Alcohol Use Disorder (AUD), run by University of Wisconsin, Madison 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 4 inclusion and 1 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 25 Jun 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 Susan Wanta (608-262-0387, schneck2@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant engagement with the STAR system (time frame: data collected at 2 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.