An interventional study of Brief Motivational Interviewing with Personalized Feedback in Alcohol Use Disorder and Liver Diseases, sponsored by Brown University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Brown University · Not applicable, Interventional, and Treatment
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria. To be eligible, the interested volunteer must:
General Exclusion Criteria. Interested volunteers must not have any of the following:
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:
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.
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
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 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.
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
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
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
| Milestone | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder |
|---|---|---|
| Started | 29 | 8 |
| Completed | 28 | 5 |
| Not completed | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder |
|---|---|---|
| Started | 28 | 5 |
| Week 1 | 27 | 5 |
| Week 2 | 27 | 5 |
| Completed | 26 | 5 |
| Not completed | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
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.
| Participants | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder |
|---|---|---|
| Percentage of Screen Eligible Who Enroll | 28 | 5 |
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.
| Participants | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder |
|---|---|---|
| Percentage of Participants Who Complete the Study | 26 | 5 |
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.
| Participants | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder |
|---|---|---|
| Percentage of Participants Who Withdraw | 0 | 0 |
Collected over Adverse event data were collected for 90 days following Baseline assessments.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcohol Use Disorder Only | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Alcohol Associated Liver Disease + Alcohol Use Disorder | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
The "Overall Number of Baseline Participants" is the count of participants who were included in analyses addressing primary aims. Since Aim 1 evaluates the feasibility of retention between "Screening" and "Baseline" visits, this overall number is the count of participants who were eligible at the "Screening" visit. For ease of interpretation, the participant flow may be viewed as a multiple baseline design, with the "Screening" visit interpreted as "Baseline 1" and "Baseline" as "Baseline 2."
| Age, Categorical(Participants) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 4 | 33 |
| >=65 years | 0 | 4 | 4 |
| Age, Continuous(years) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| Mean | 44.3 (21 to 63) | 58.3 (33 to 80) | 47.3 (21 to 80) |
| Sex/Gender, Customized(Participants) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| Sex/Gender, Customized — Cisgender Man | 14 | 7 | 21 |
| Sex/Gender, Customized — Cisgender Woman | 14 | 1 | 15 |
| Sex/Gender, Customized — Transgender Woman | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 2 | 11 |
| Not Hispanic or Latino | 19 | 6 | 25 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 15 | 6 | 21 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 9 | 1 | 10 |
| Region of Enrollment(participants) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| United States | 29 | 8 | 37 |
| Recruitment Source(Participants) | Alcohol Use Disorder Only | Alcohol Associated Liver Disease + Alcohol Use Disorder | Total |
|---|---|---|---|
| Community | 29 | 1 | 30 |
| Clinic | 0 | 7 | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified data will be kept and used for future research on chronic disease and substance use. This includes biospecimens.
Supporting information: Study protocol, Sap
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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