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 system

Trial Health

77
On Track

Trial Health Score

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

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress23%
Sep 2025Jul 2029

Study Start

First participant enrolled

September 24, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

3.4 years

First QC Date

April 30, 2026

Last Update Submit

June 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participant engagement with the STAR system

    Measured as days of engagement with the recovery system.

    data collected at 2 and 4 months

Secondary Outcomes (10)

  • Number of heavy drinking days in the previous 28 days

    data collected at baseline, 2, 4 months

  • Number of drinking days in the previous 28 days

    data collected at baseline, 2, 4 months

  • Flourishing Scale Score

    data collected at baseline, 2, 4 months

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

    data collected at baseline, 2, 4 months

  • Multidimensional Inventory of Recovery Capital (MIRC) Score: Total Score

    data collected at baseline, 2, 4 months

  • +5 more secondary outcomes

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)
  • 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

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John Curtin, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

September 24, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

July 31, 2029

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

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

Locations