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Optimizing Smart Technology for Addiction Recovery

Optimizing Algorithmic Feedback About Lapse Risk for Trust, Engagement, and Clinical Outcomes for Alcohol Use Disorder

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07573540
Acronym
STAR
Enrollment
416
Registered
2026-05-07
Start date
2026-05-01
Completion date
2029-05-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Alcohol Use Disorder (AUD)

Brief 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 digital therapeutic app

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.

Interventions

DEVICESTAR

Automated recovery support messaging system for participants with alcohol use disorder (AUD), paired with a machine learning guided relapse risk prediction model.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* meet criteria for alcohol use disorder with at least moderate severity (\>= 4 DSM-5 criteria assessed via module E of the Structured Clinical Interview for DSM-5182) * 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)

Exclusion criteria

* medical or psychiatric co-morbidities that preclude use of a smartphone

Design outcomes

Primary

MeasureTime frameDescription
Change in heavy drinking days in the previous 60 daysdata collected at baseline, 2, 4 monthsData collected via Timeline Followback (TLFB) conducted by interview and 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, 3-5, 5-6, 7-8, over 8). Greater than 3 drinks are considered heavy drinking days for women and greater than 4 drinks are considered heavy drinking days for men.
Change in drinking days in the previous 60 daysdata collected at baseline, 2, 4 monthsData collected via Timeline Followback (TLFB) conducted by interview and 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.
Change in lapse probabilityBaseline to 4 monthsData measured via prediction model output which provides a daily lapse probability. This probability is a numeric value from 0-1, zero representing no probability of lapse and 1 representing 100% probability of lapse.

Secondary

MeasureTime frameDescription
Flourishing Scale Scoreup to 4 months10 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.
Generalized Anxiety Disorder-7 (GAD-7) Scoreup to 4 months7 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.
Multidimensional Inventory of Recovery Capital (MIRC) Scoreup to 4 months1-4 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 7-28.
Patient Health Questionnaire (PQH-9) Scoreup to 4 months9 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.

Countries

United States

Contacts

CONTACTSusan Wanta
schneck2@wisc.edu608-262-0387
CONTACTThea Blum
tblm4@wisc.edu608-262-1362
PRINCIPAL_INVESTIGATORJohn Curtain, PhD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026