NCT07573540

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2029

First Submitted

Initial submission to the registry

April 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Alcohol Use DisorderAlcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (3)

  • Change in heavy drinking days in the previous 60 days

    Data 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.

    data collected at baseline, 2, 4 months

  • Change in drinking days in the previous 60 days

    Data 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.

    data collected at baseline, 2, 4 months

  • Change in lapse probability

    Data 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.

    Baseline to 4 months

Secondary Outcomes (4)

  • Flourishing Scale Score

    up to 4 months

  • Generalized Anxiety Disorder-7 (GAD-7) Score

    up to 4 months

  • Multidimensional Inventory of Recovery Capital (MIRC) Score

    up to 4 months

  • Patient Health Questionnaire (PQH-9) Score

    up to 4 months

Study Arms (1)

STAR

EXPERIMENTAL

Participants will use the STAR automated recover support system for 4 months

Device: STAR

Interventions

STARDEVICE

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

Also known as: Smart Technology for Addiction Recovery
STAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John Curtain, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Wanta

CONTACT

608-262-0387schneck2@wisc.edu

Thea Blum

CONTACT

608-262-1362tblm4@wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 7, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

May 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)