Optimizing Smart Technology for Addiction Recovery (STAR)

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

Study Overview

• Status: Recruiting
• Conditions: Alcohol Use Disorder; Alcohol Use Disorder (AUD)
• Intervention / Treatment: Device: STAR

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 Type: Interventional
• Enrollment (Estimated): 416
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Wanta; Phone Number: 608-262-0387; Email: schneck2@wisc.edu
• Study Contact Backup: Name: Thea Blum; Phone Number: 608-262-1362; Email: tblm4@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • Recruiting
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR; Participants will use the STAR automated recover support system for 4 months	Device: STAR; Automated recovery support messaging system for participants with alcohol use disorder (AUD), paired with a machine learning guided relapse risk prediction model.; Other Names: Smart Technology for Addiction Recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant engagement with the STAR system	Measured as days of engagement with the recovery system.	data collected at 2 and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	data collected at 2 and 4 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: John Curtin, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 2024-0869; A487400 (Other Identifier: UW Madison); 1R01AA031762-01 (U.S. NIH Grant/Contract); Protocol Version 4/22/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No