Biobehavioral Pathways Underlying Alcohol Use and Health

NCT05135767 | Completed Results

• 2 other identifiers: 2011002840P20GM130414
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

Alcohol-associated liver disease (ALD) and alcohol use disorder (AUD) are intersecting diseases that add substantially to the global burden of disease and mortality. ALD refers to a spectrum of liver tissue injury caused by chronic and excessive alcohol use. Although reducing drinking is a main treatment goal, this is often unachievable for many patients with ALD due to an underlying AUD characterized by alcohol craving and drinking despite harms. While numerous, high-quality studies demonstrate effectiveness of brief psychosocial interventions for AUD, few trials have tested the efficacy of psychosocial interventions to reduce drinking in individuals with or at risk for ALD. This project establishes a team of addiction scientists and hepatologists to form a partnership and support future collaboration.

Conditions

Alcohol Use Disorder; Liver Diseases

Keywords

Alcohol Use Disorder; Liver Diseases; Craving; Ecological Momentary Assessment; Biobehavioral

Outcome Measures

Primary Outcomes (3)

• Percentage of Screen Eligible Who Enroll

  Feasibility will be evaluated through the percentage of those who are screened as eligible for the study who enroll as participants in the study. The target enrollment rate is greater than or equal to 60% of screen eligible.

  3 months

• Percentage of Participants Who Complete the Study

  Feasibility will be evaluated through the percentage of those participants who are enrolled in the study who complete the study. The target retention rate is greater than or equal to 70% of enrolled participants.

  3 months

• Percentage of Participants Who Withdraw

  Acceptability will be evaluated through the percentage of those participants who enroll in the study who withdraw from the study. A participant is considered to have withdrawn from the study if they indicate that they no longer wish to be a part of the study (i.e., not lost to contact). The target withdrawal rate is less than or equal to 20% of enrolled participants.

  3 months

Study Arms (2)

Alcohol Use Disorder Only

ACTIVE COMPARATOR

Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.

Behavioral: Brief Motivational Interviewing with Personalized Feedback

Alcohol Associated Liver Disease + Alcohol Use Disorder

ACTIVE COMPARATOR

Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.

Behavioral: Brief Motivational Interviewing with Personalized Feedback

Interventions

Brief Motivational Interviewing with Personalized Feedback BEHAVIORAL

A brief motivational interviewing (MI) intervention will target drinking. The intervention will leverage in-depth personalized feedback to identify areas of progress and barriers to change. The personalized feedback will include results of laboratory diagnostic tests, summary reports of timeline followback interviews, and graphical depictions of self-monitoring reports collected on smartphones in daily life. The brief intervention will include an initial 60-minute videoconference session, two brief, 5-10 minute phone-call check-ins completed one and two weeks after the initial intervention, and a 30-minute videoconference booster session completed three weeks after the initial intervention.

Alcohol Associated Liver Disease + Alcohol Use Disorder; Alcohol Use Disorder Only

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years of age.
• Meet the Diagnostic and Statistical Manual-5 criteria for alcohol use disorder, indicated by meeting 2 or more symptom criteria.
• If male, report 14 or more standard alcoholic drinks per week, or if female, report 7 or more standard alcoholic drinks per week at any point in the 90 days prior to enrollment.
• Be able to speak and read English or Spanish in order to provide written informed consent and understand written and oral instructions in English or Spanish.

You may not qualify if:

• Meet the Diagnostic and Statistical Manual-5 criteria for a current diagnosis of psychotic disorders.
• Currently receiving specialized psychosocial treatment for an alcohol-use or drug problem.
• If female, pregnant or nursing.
• Be anyone who, in the opinion of the investigative team, could not currently be safely withdrawn from alcohol without medical detoxification.
• A BMI of 40 or more, or 35 or more and experiencing obesity-related health conditions, such as high blood pressure or diabetes.
• Known medical conditions that, in the opinion of the investigative team, would confound results (e.g., uncontrolled infections, multiorgan failure, uncontrolled upper gastrointestinal bleeding, hepatocellular carcinoma or other active malignancies except skin cancer).
• Patients who have received a liver transplant or are too ill to participate.
• Pre-existing loss of kidney function with estimated glomerular filtration rate \< 30.
• Any other condition that, in the opinion of the investigative team, would make the interested volunteer unsuitable for the study or unable to comply with the requirements.
• To be eligible in the ALD+AUD group, the interested volunteer must be diagnosed with advanced alcohol-associated liver disease (i.e., either alcoholic hepatitis or alcoholic cirrhosis). ALD will be determined by chart review. Interested volunteers must have one of the following:
• Positive liver biopsy, or
• Fibroscan® score \> 12.5, or
• Evidence of a nodular liver or portal hypertension on abdominal imaging, or
• Presence of portal hypertensive complications such as hepatic encephalopathy, ascites, or varices, or
• Fibrosis-4 index \>= 3.25, or

Sponsors & Collaborators

• Brown University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• Rhode Island Hospital: collaborator

Study Sites (2)

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcoholism; Liver Diseases

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Digestive System Diseases

Results Point of Contact

• Title: Hayley Treloar Padovano, PhD
• Organization: Brown University

hayley_treloar@brown.edu

4018636623

Study Officials

• Hayley Treloar Padovano, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 26, 2021
• Study Start: February 28, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Core data including biospecimens collected to fulfill the aims of the Center for Addiction and Disease Risk Exacerbation will be available to request immediately following publication with no prespecified end date. Project-specific data collected to fulfill the research aims outlined in this clinical trial registration will be made available beginning 9 months and ending 36 months following article publication.
• Access Criteria: After all data are collected and the results of the study are published, deidentified data and biospecimens may be made available to other qualified investigators at Brown or other institutions upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.

Locations

US (2)