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Biobehavioral Pathways Underlying Alcohol Use and Health
NA trial testing Brief Motivational Interviewing with Personalized Feedback in Alcohol Use Disorder in 37 participants. Completed in 27 October 2023.
| Lead sponsor | Brown University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 28 February 2022 |
| Primary completion | 27 October 2023 |
| Estimated completion | 27 October 2023 |
| Sites | 2 locations across United States |
Brown University
18 and older, any sex, with Alcohol Use Disorder or Liver Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Alcohol Use Disorder Only | 28 | |
| Alcohol Associated Liver Disease + Alcohol Use Disorder | 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.
| Group | Value | 95% CI |
|---|---|---|
| Alcohol Use Disorder Only | 26 | |
| Alcohol Associated Liver Disease + Alcohol Use Disorder | 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 A participant is considered to have withdrawn from the study if they indicate that they no longer wish to be a part of the study (i.e., not lost to contact).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.
| Group | Value | 95% CI |
|---|---|---|
| Alcohol Use Disorder Only | 0 | |
| Alcohol Associated Liver Disease + Alcohol Use Disorder | 0 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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