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Stepped Alcohol Intervention for Alcohol-related Liver Disease

N/A

Recruiting

Led By Mandana Khalili, M.D.

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of chronic liver disease (CLD)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to help people with chronic liver disease who have unhealthy alcohol use. The new treatment includes 3 sessions of motivational interviewing, and referral to addiction medicine if necessary. The trial will measure how well the new treatment works at 6 and 12 months.

Who is the study for?

This trial is for adults over 18 with chronic liver disease who drink more alcohol than recommended: over 7 drinks per week for women and 14 for men, or at least one heavy drinking day weekly. They must be able to use a phone or digital device but can't join if they're in formal alcohol treatment, pregnant/breastfeeding without birth control, non-English/Spanish speakers, unable to consent, or have severe medical/psychiatric issues.

What is being tested?

The study tests a Stepped Alcohol Treatment (SAT) using telemedicine against Usual Care (UC) to see if it helps reduce unhealthy drinking in liver disease patients. SAT involves motivational interviews and possible addiction medicine referrals. Participants are randomly assigned to either group and assessed after 6 and 12 months.

What are the potential side effects?

Since the interventions involve counseling sessions and potential referral to addiction services rather than medication, there may not be direct side effects like those associated with drugs; however, participants might experience emotional discomfort during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with chronic liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in alcohol use

Secondary study objectives

Alcohol use cessation

Drinks per week

Liver-related outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol useExperimental Treatment1 Intervention

For participants randomized to SAT, consistent with stepped care, treatment will begin with lower intensity services that are stepped up, if necessary, at a predefined time point. Step 1 consists of three motivational interviewing (MI)sessions delivered every 2 weeks. At the 3-month assessment, those with non-response to MI, defined as continued unhealthy alcohol use in the prior 14 days, will be referred to on site physician managed addiction specialty services (Step 2) for higher intensity services.

Group II: Usual Care (UC)Active Control1 Intervention

UC participants will receive their usual services in hepatology. They will also be given publicly available patient education materials regarding risk associated with unhealthy drinking (mail/email or in-person if desired) and will be asked to follow up with their physician should they have questions about information provided in the handouts. UC participants' hepatology provider will be notified if AUDIT-C scores are greater than 3 at baseline. All UC participants will have access to alcohol and other substance use treatment available to patients at their respective sites.

0 / 1Eligibility criteria met