LDART for Alcoholism

(LDART Trial)

Overseen By Li Yan McCurdy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Non-English speakers, Vulnerable populations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool called Let's Do Addiction Recovery Together! (LDART) to help people reduce alcohol intake. Researchers aim to determine if this tool is more helpful and user-friendly than simply providing a list of resources. The study seeks participants in Connecticut who have recently experienced several heavy drinking days and wish to reduce their alcohol consumption. Participants will need a smartphone with internet access.

As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative digital health solutions.

Do I have to stop taking my current medications for the LDART trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital intervention is safe for adults with alcohol use disorder?

Research has shown that LDART, a digital tool for individuals with alcohol use disorder, is being tested for safety and effectiveness. In an earlier study, adults who drank heavily used LDART every night. The study aimed to determine if participants would use the tool and how it might help them reduce alcohol consumption.

The study found no serious side effects, indicating that LDART is safe to use. As a digital tool, LDART does not have the same side effects as medications, making it a promising option for those seeking to reduce alcohol use without additional medications.

Overall, while more research is needed to fully understand its effects, current data shows no major safety concerns with using LDART. ^{1 2 3 4 5}

Why are researchers excited about this trial?

LDART is unique because it leverages digital therapy to help treat alcoholism, offering a potentially more accessible and convenient option than traditional face-to-face counseling or medication. Researchers are excited about this treatment because it provides 24/7 access to therapeutic resources, which can empower individuals to manage their condition in real-time, enhancing engagement and adherence to treatment. Unlike standard options like disulfiram or naltrexone, which involve medication, LDART focuses on behavioral change through digital interaction, potentially reducing the need for medical supervision and minimizing side effects.

What evidence suggests that LDART is effective for alcohol use disorder?

Research on digital tools for assisting individuals with alcohol use disorder is still developing. LDART, which participants in this trial may receive, is one such tool designed to support recovery. Although specific data on LDART is not yet available, digital tools in general have shown promise in maintaining engagement and support during recovery. Studies suggest that community and emotional support effectively manage alcohol use disorder. These methods often focus on connecting individuals with helpful resources and support systems, aiding in reducing alcohol consumption. LDART's digital format may facilitate access to help and maintain connections with supportive networks. ^{6 7 8 9 10}

Who Is on the Research Team?

Li Yan McCurdy, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults in Connecticut with alcohol use disorder who've had heavy drinking days recently and want to cut down or quit. They must have a smartphone, internet access, and score high on specific AUD tests. People can't join if they can't consent, don't speak English, are vulnerable individuals, or can't complete the study soon.

Inclusion Criteria

Currently reside in Connecticut, USA

Have a smartphone that can send and receive text messages and have internet access that can be accessed over the course of a month

Had ≥5 heavy drinking days in the past 28 days

Exclusion Criteria

I am able to understand and agree to the study's requirements.

Unable to speak, read, or write in English

Vulnerable population status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the LDART digital intervention for 28 days

4 weeks

Online engagement

Follow-up

Participants are monitored for changes in recovery group engagement and drinking behavior

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LDART

Trial Overview The study is testing 'Let's Do Addiction Recovery Together!' (LDART), a digital intervention for those with alcohol use disorder. Participants will be randomly placed into two groups: one using LDART and another receiving a resource list to compare effectiveness.

How Is the Trial Designed?

Group I: Resource list Experimental Treatment 1 Intervention

Participants will be emailed a 3-page resource list.

Group II: LDART Experimental Treatment 2 Interventions

Participants will be given access to LDART for 28 days.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10882804/

Predictors of treatment outcome for individuals with alcohol ... A total of 57% of individuals in BSCT attained a level of CD, as opposed to 43% in MET. Females were significantly better in attaining low-risk ...

2. semanticscholar.org semanticscholar.org/paper/Individual-and-Community-Social-Determinants-of-and-Swan-Aldridge/d16902693a4dccb0cd6c4c2d7a90b6cb7bc06c66

Individual and Community Social Determinants of Health ... Effectiveness of community psychosocial and pharmacological treatments for alcohol use disorder: A national observational cohort study in England. · Medicine, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3505028/

Effectiveness of public health programs for decreasing ... After years of implementation, this program was found to have negligible effects on preventing drug and alcohol use. The program was believed to be ineffective ...

4. mdpi.com mdpi.com/2227-9059/10/5/1192

Alcohol Use Disorder: Neurobiology and Therapeutics This review summarizes the impact of alcohol toxicity on brain neurocircuitry in the context of AUD and discusses pharmacological and non-pharmacological ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7643818/

Epidemiology of Recovery From Alcohol Use Disorder - PMC Approximately 70% of persons with AUD and alcohol problems improve without interventions (natural recovery), and fewer than 25% utilize alcohol- ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0292293

A non-randomized pilot study protocol of a novel social ... We will recruit 30 adults who engaged in past-year hazardous alcohol use and have some desire to cut down or quit to use LDART every night for a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10284465/

Hazardous drinking and alcohol use disorders - PubMed Central Chronic regular alcohol use contributes to alcohol use disorders (AUDs) and other psychiatric disorders, increases risk of other medical ...

8. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07221383

LDART for Alcohol Use Disorder (LDART) - ICH GCP This study is a pilot randomized controlled trial to evaluate feasibility, acceptability, and preliminary efficacy of a digital intervention ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/07/NCT06022107/Prot_SAP_000.pdf

Piloting a novel social support intervention for addiction ... The primary objectives of this study are to determine whether LDART is feasible, acceptable, and efficacious in reducing alcohol use and ...

10. cdc.gov cdc.gov/alcohol/?sessionGUID=49a28531-ab0d-3a6b-03c9-7c009b6bcd74&webSyncID=59329ad8-83c9-d902-bc99-93ced268bead&sessionGUID=49a28531-ab0d-3a6b-03c9-7c009b6bcd74

Alcohol Use Excessive alcohol use harms our health and well-being. These data show the impact it has. Addressing Excessive Alcohol Use: State Fact Sheets.