N/A
N=37
Biobehavioral Pathways Underlying Alcohol Use and Health
Alcohol Use Disorder · Liver Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05135767 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Screen Eligible Who Enroll — 28; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Motivational Interviewing with Personalized Feedback (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Screen Eligible Who Enroll |
28; 5 | — |
| PRIMARY Percentage of Participants Who Complete the Study |
26; 5 | — |
| PRIMARY Percentage of Participants Who Withdraw |
0; 0 | — |
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.
Eligibility Criteria
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 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.
General Exclusion Criteria. Interested volunteers must not have any of the following:
- 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 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.
- Fibrosis-4 index >= 3.25*, or
- Aspartate transaminase-platelet ratio index >= 1.0**, or
- Gamma-glutamyl transpeptidase-to-platelet ratio >= 0.32.
Data sourced from ClinicalTrials.gov (NCT05135767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.