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Enrolling by invitation NCT07221383

LDART for Alcohol Use Disorder

No phase Interventional Alcohol Use Disorder Hazardous Alcohol Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LDART, Psychoeducational control.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder, Hazardous Alcohol Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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. P
  • 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.

Primary outcome measures

  • Recruitment rate [Time frame: From enrollment to the final assessment time point (Day 56)]
  • Accrual rate [Time frame: From enrollment to the final assessment time point (Day 56)]
  • Retention rate [Time frame: From enrollment to the final assessment time point (Day 56)]
  • Intervention engagement [Time frame: From beginning the intervention (Day 1) to the end of the intervention period (Day 28)]
  • Intervention acceptability [Time frame: The second assessment time point (post-intervention, Day 28)]
Secondary outcome measures (3)
  • Change from baseline in number of drinking days [Time frame: Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)]
  • Change from baseline in number of heavy drinking days [Time frame: 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 [Time frame: Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Yale University — New Haven

Identifiers

NCT: NCT07221383 · 2000040798 · K12DA000167

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗