LDART for Alcohol Use Disorder

NCT07221383 | Enrolling By Invitation FDA Device

• 2 other identifiers: 2000040798K12DA000167
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot randomized controlled trial to evaluate feasibility, acceptability, and preliminary efficacy of a digital intervention called Let's Do Addiction Recovery Together! (LDART) in adults with alcohol use disorder, relative to a control group.

Conditions

Alcohol Use Disorder; Hazardous Alcohol Use

Keywords

social support; digital intervention; mutual-help groups; alcohol use disorder; addiction recovery; peer support

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  The percentage of eligible participants who are enrolled relative to the total number of eligible potential participants who completed the screening.

  From enrollment to the final assessment time point (Day 56)

• Accrual rate

  The rate of enrollment, defined as number of participants enrolled per month.

  From enrollment to the final assessment time point (Day 56)

• Retention rate

  The percentage of enrolled participants who complete all study-related procedures (i.e., assessments at 3 monthly time points).

  From enrollment to the final assessment time point (Day 56)

• Intervention engagement

  Number of nights that participants in the active condition completed the activities on the LDART website, out of 28 nights.

  From beginning the intervention (Day 1) to the end of the intervention period (Day 28)

• Intervention acceptability

  Rating scores on the end-user version of the Mobile App Rating Scale (uMARS). Total score range 1-5 with higher scores indicating a better quality app.

  The second assessment time point (post-intervention, Day 28)

Secondary Outcomes (3)

• Change from baseline in number of drinking days

  Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)

• Change from baseline in number of heavy drinking days

  Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)

• Change from baseline in number of hours spent engaging with recovery groups

  Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)

Study Arms (2)

LDART

EXPERIMENTAL

Participants will be given access to LDART for 28 days.

Device: LDART

Rethinking Drinking

OTHER

Participants will be emailed a PDF of this psychoeducational booklet.

Behavioral: Psychoeducational control

Interventions

LDART DEVICE

Let's Do Addiction Recovery Together! (LDART) is a web-based intervention grounded in social cognitive theory that is designed to reduce hazardous alcohol use. It has three active ingredients: 1) daily recovery goal setting and tracking, 2) motivational video, audio, and written messages from individuals in recovery, and 3) information on several community-based recovery groups (e.g., mutual-help groups, recovery community centers) that provide free, publicly available meetings and activities. Participants receive a text message reminder each night to go to the website to complete the activities, and a text message reminder each morning of the goal they set for themselves, with the option to change it. It only takes a few minutes to use LDART each day over the 4-week intervention period.

LDART

Psychoeducational control BEHAVIORAL

This is a 20-page psychoeducational booklet created by the National Institute on Alcohol Abuse \& Alcoholism (NIAAA) called "Rethinking Drinking". It contains several suggestions, strategies and resources for helping people who want to reduce their alcohol use. Participants will be encouraged to access the booklet for a few minutes each night over the 4-week intervention period.

Rethinking Drinking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently reside in Connecticut, USA
• Have a smartphone that can send and receive text messages and have internet access that can be access over the course of a month
• Had ≥5 heavy drinking days (defined as ≥4 or ≥5 drinks in one sitting for women and men, respectively) in the past 28 days
• Alcohol Symptom Checklist ≥4, indicating moderate/severe AUD
• Have some self-reported desire to cut down or quit drinking

You may not qualify if:

• Unable to provide informed consent, as assessed by the consent quiz
• Unable to speak, read, or write in English
• Vulnerable population status
• Unlikely to be able to complete study procedures in the next 2-3 months

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Li Yan McCurdy, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start: April 29, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)