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Biobehavioral Pathways Underlying Alcohol Use and Health

Biobehavioral Pathways Underlying Alcohol Use and Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05135767
Enrollment
37
Registered
2021-11-26
Start date
2022-02-28
Completion date
2023-10-27
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Liver Diseases

Keywords

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

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.

Detailed description

The long-term goal of this research program is to develop more effective behavioral interventions to halt the progression of alcohol-associated liver disease (ALD) by addressing at-risk drinking patterns and alcohol use disorder (AUD). The investigators originally proposed a prospective, two-arm intervention study comparing individuals with ALD and AUD vs. those with AUD and without a prior history of ALD or current blood biomarkers suggestive of ALD. The proposed project was designed to demonstrate the feasibility of implementing a brief motivational intervention targeting drinking for patients with ALD recruited from specialty gastroenterology clinics. To keep pace with the original overall recruitment targets within the confines of an adjusted award period, the approach was modified to continue recruiting individuals with AUD and at risk for ALD from the community beyond the original balanced sample size for this group. After clinic and community recruitment, screening, and enrollment, participants complete four weeks of digital health self-monitoring of precursors of drinking in real-world settings, paired blood biomarkers of liver function, inflammation, and immune response collected prior to the behavioral intervention, at 3 weeks, and at 3-month follow-up. After the first week of self-monitoring, participants attend an in-person research visit involving questionnaires, a laboratory alcohol-cue-reactivity task, and receive a 60-minute, video-conference brief motivational intervention with personalized feedback from self-monitoring reports completed via smartphones in daily life and liver-health biomarkers. The intervention is followed by three weekly research visits culminating with a 30-minute booster video-conference intervention with personalized feedback and exit interviews. A final, in-person research visit is completed at 3 months to evaluate post-intervention, near-term outcomes. Primarily, this project aims to establish our team and collect initial feasibility and acceptability data for a full-scale clinical trial evaluating biobehavioral endophenotypes AUD in individuals at risk for or with chronic liver disease. At-risk drinking is studied in the setting of a brief intervention designed to enhance knowledge of liver-health risk factors, identify personal precursors of drinking, and increase motivation for sustained change. Secondarily, this project aims to test whether biobehavioral endophenotypes associated with alcohol-use outcomes in clinical trials can serve as indicators of AUD treatment response among individuals at risk for or with ALD. Biomarkers of inflammation and immune activation are explored as mechanisms of persistence of endophenotypes, specifically levels of pro-inflammatory cytokines, chemokines, and others implicated in the pathogenesis of ALD. All study procedures and intervention are offered in English and Spanish, preparing for future full-scale clinical intervention trials among monolingual Spanish-speaking individuals.

Interventions

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.

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Rhode Island Hospital
CollaboratorOTHER
Brown University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

General Inclusion Criteria. To be eligible, the interested volunteer must: 1. Be at least 18 years of age. 2. Meet the Diagnostic and Statistical Manual-5 criteria for alcohol use disorder, indicated by meeting 2 or more symptom criteria. 3. 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. 4. 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: 1. Meet the Diagnostic and Statistical Manual-5 criteria for a current diagnosis of psychotic disorders. 2. Currently receiving specialized psychosocial treatment for an alcohol-use or drug problem. 3. If female, pregnant or nursing. 4. Be anyone who, in the opinion of the investigative team, could not currently be safely withdrawn from alcohol without medical detoxification. 5. A BMI of 40 or more, or 35 or more and experiencing obesity-related health conditions, such as high blood pressure or diabetes. 6. 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). 7. Patients who have received a liver transplant or are too ill to participate. 8. Pre-existing loss of kidney function with estimated glomerular filtration rate \< 30. 9. 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 ALD + AUD Arm. 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: 1. Positive liver biopsy, or 2. Fibroscan® score \> 12.5, or 3. Evidence of a nodular liver or portal hypertension on abdominal imaging, or 4. Presence of portal hypertensive complications such as hepatic encephalopathy, ascites, or varices, or 5. Fibrosis-4 index \>= 3.25, or 6. Aspartate transaminase-platelet ratio index \>= 1.0. Additional

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Screen Eligible Who Enroll3 monthsFeasibility 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 Study3 monthsFeasibility 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 Withdraw3 monthsAcceptability 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
29
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.
8
Total37

Withdrawals & dropouts

PeriodReasonFG000FG001
Active Study PhaseLost to Follow-up20
BaselineLost to Follow-up11
BaselineWithdrawal by Subject02

Baseline characteristics

CharacteristicAlcohol Use Disorder OnlyAlcohol Associated Liver Disease + Alcohol Use DisorderTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants4 Participants4 Participants
Age, Categorical
Between 18 and 65 years
29 Participants4 Participants33 Participants
Age, Continuous44.3 years58.3 years47.3 years
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants2 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants6 Participants25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants0 Participants3 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants1 Participants10 Participants
Race (NIH/OMB)
White
15 Participants6 Participants21 Participants
Recruitment Source
Clinic
0 Participants7 Participants7 Participants
Recruitment Source
Community
29 Participants1 Participants30 Participants
Region of Enrollment
United States
29 participants8 participants37 participants
Sex/Gender, Customized
Sex/Gender, Customized
Cisgender Man
14 Participants7 Participants21 Participants
Sex/Gender, Customized
Sex/Gender, Customized
Cisgender Woman
14 Participants1 Participants15 Participants
Sex/Gender, Customized
Sex/Gender, Customized
Transgender Woman
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 8
other
Total, other adverse events
0 / 290 / 8
serious
Total, serious adverse events
0 / 290 / 8

Outcome results

Primary

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.

Time frame: 3 months

Population: Overall Number of Participants Analyzed in each Arm/Group is the number of participants who enrolled in the study, defined as screening eligible and completing baseline assessments.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Alcohol Use Disorder OnlyPercentage of Participants Who Complete the Study26 Participants
Alcohol Associated Liver Disease + Alcohol Use DisorderPercentage of Participants Who Complete the Study5 Participants
Primary

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.

Time frame: 3 months

Population: Overall Number of Participants Analyzed in each Arm/Group is the number of participants who enrolled in the study, defined as screening eligible and completing baseline assessments.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Alcohol Use Disorder OnlyPercentage of Participants Who Withdraw0 Participants
Alcohol Associated Liver Disease + Alcohol Use DisorderPercentage of Participants Who Withdraw0 Participants
Primary

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.

Time frame: 3 months

Population: Overall Number of Participants Analyzed in each Arm/Group is the number of participants who screened eligible for the study.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Alcohol Use Disorder OnlyPercentage of Screen Eligible Who Enroll28 Participants
Alcohol Associated Liver Disease + Alcohol Use DisorderPercentage of Screen Eligible Who Enroll5 Participants

Source: ClinicalTrials.gov · Data processed: May 23, 2026