Biobehavioral Pathways Underlying Alcohol Use and Health

Sponsor

Brown University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05135767

Collaborator

National Institute of General Medical Sciences (NIGMS) (NIH), Rhode Island Hospital (Other)

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Alcohol-associated liver disease (AALD) and alcohol use disorder (AUD) are intersecting diseases that add substantially to the global burden of disease and mortality. AALD 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 AALD patients due to an underlying AUD characterized by craving, negative affect, and alcohol seeking 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 AALD patients. This study unites a team of addiction scientists and hepatologists to form a partnership for future work testing AUD interventions integrated with AALD care.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder Liver Diseases	Behavioral: Brief Motivational Interviewing with Personalized Feedback	N/A

Detailed Description

The primary aim of this project is to demonstrate the feasibility of implementing a brief motivational intervention targeting alcohol use for patients with alcohol-associated liver disease (AALD). The intervention will include personalized feedback from biomarkers of liver function, drinking patterns, and self-monitoring via smartphone reports in daily life. Participants (n=44) will exceed moderate drinking guidelines and will be recruited from local hospitals and the community. This is a parallel group design in which all participants receive the same intervention. Half of the participants will have AALD and meet criteria for AUD, and half will have AUD only without evidence of advanced liver disease. The protocol includes a 1-week screening phase, 3-week intervention phase, and 3-month follow-up. In addition to demonstrating feasibility, this project aims to test whether behavioral endophenotypes associated with alcohol-use outcomes in clinical trials are more resistant to change during AUD intervention for AALD patients with AUD relative to those with AUD only. A final aim is to explore biomarkers of inflammation and immune activation as mechanisms of persistence of endophenotypes, specifically levels of pro-inflammatory cytokines, chemokines, and others implicated in the pathogenesis of AALD.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Biobehavioral Pathways Underlying Alcohol Use and Health

Actual Study Start Date :

Feb 28, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Alcohol Use Disorder Only 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 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 session, two brief, 5-10 minute check-ins, and a 30 minute booster session.
Active Comparator: Alcohol Associated Liver Disease + Alcohol Use Disorder 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 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 session, two brief, 5-10 minute check-ins, and a 30 minute booster session.

Arm

Intervention/Treatment

Active Comparator: Alcohol Use Disorder Only

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

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 session, two brief, 5-10 minute check-ins, and a 30 minute booster session.

Active Comparator: Alcohol Associated Liver Disease + Alcohol Use Disorder

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

Outcome Measures

Primary Outcome Measures

Number of Participants Enrolled Per Month [24 months]
Feasibility will be evaluated through the pace of recruitment, i.e., the number participants recruited per month. The target is two participants enrolling in the study per month.
Percentage of Screen Eligible Who Enroll [24 months]
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.
Percentage of Participants Who Complete the Study [24 months]
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.
Percentage of Participants Who Withdraw [24 months]
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.

Secondary Outcome Measures

Craving in Daily Life [4 weeks]
Ecological momentary assessment (EMA) is a method for collecting self-monitoring data using smartphones. Participants will complete smartphone reports for a total of 4 weeks including a 1-week screening phase and 3-week intervention phase.Participants will self-monitor and rate the intensity of their alcohol craving in daily life. They will also indicate situational and contextual factors, including the presence of visible alcohol cues. Craving will be assessed using a visual analogue scale from 0 to 10 via the question, "How strong is your craving to drink alcohol right now?".
Craving in the Human Laboratory [20 minutes]
Participants will be exposed to alcohol and water cues in the human laboratory via a standardized in vivo cue reactivity paradigm. The participant's typical alcoholic beverage is used as the in vivo alcohol cue. Each cue exposure lasts approximately 90 seconds. An initial relaxation period is followed by exposure to the water cue, and two repeated exposures to the alcohol cue. To match assessment of craving in daily life, craving will be assessed using a visual analogue scale from 0 to 10 via the question, "How strong is your craving to drink alcohol right now?". Craving will also be assessed with the Alcohol Craving Questionnaire--Short Form-Revised, a 12-item self-administered, multidimensional state measure of acute alcohol craving.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

General Inclusion Criteria. To be eligible, the interested volunteer must:

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 an average of 14 or more standard alcoholic drinks per week, or if female, report an average of 7 or more standard alcoholic drinks per week.
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.

General Exclusion Criteria. Interested volunteers must not have any of the following:

Meet the Diagnostic and Statistical Manual-5 criteria for a current or lifetime diagnosis of psychotic disorders.
Meet the Diagnostic and Statistical Manual-5 criteria for a current major depressive episode or bipolar disorder.
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.

Additional Inclusion Criteria for the AALD + AUD Arm.

To be eligible in the AALD+AUD group, the interested volunteer must be diagnosed with advanced alcohol-associated liver disease. AALD 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
Aspartate transaminase-platelet ratio index >= 1.0.

Additional Exclusion Criteria for the AUD Only Arm. To be eligible in the AUD-only group, the interested volunteer must not show the following diagnostic test results indicating advanced, alcoholic fibrosis >=F3.