LDART for Alcohol Use Disorder (LDART)

A Pilot Randomized Controlled Trial of LDART, a Social Support Intervention for Alcohol Use Disorder

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alcohol Use Disorder; Hazardous Alcohol Use
• Intervention / Treatment: Device: LDART; Behavioral: Psychoeducational control

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LDART; Participants will be given access to LDART for 28 days.	Device: LDART; 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.
Other: Rethinking Drinking; Participants will be emailed a PDF of this psychoeducational booklet.	Behavioral: Psychoeducational control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in number of drinking days	Change in self-reported number of drinking days in the past 28 days, as measured using the Timeline Follow-back.	Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)
Change from baseline in number of heavy drinking days	Change in self-reported number of heavy drinking days (defined as 4 or more drinks for women or 5 or more drinks for in one sitting) in the past 28 days, as measured using the Timeline Follow-back.	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	Self-reported number of hours spent engaging with recovery groups in the past 28 days	Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Li Yan McCurdy, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: October 23, 2025
• First Posted (Actual): October 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: social support; digital intervention; alcohol use disorder; peer support; mutual-help groups; addiction recovery
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 2000040798; K12DA000167 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes