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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in alcohol use
Secondary outcome measures
Alcohol use cessation
Drinks per week
Liver-related outcomes
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.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,375 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,817 Total Patients Enrolled
Mandana Khalili, M.D.Principal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I prefer to communicate in a language other than English or Spanish.I am 18 years old or older.I have been diagnosed with chronic liver disease.I can use a phone or digital device like a computer, tablet, or smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use
- Group 2: Usual Care (UC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment of participants in this trial?
"Affirmative. Information on clinicaltrials.gov indicates that this medical trial is still recruiting participants, with initial postings occurring February 1st 2022 and the most recent update being April 25th 2022. 180 patients are needed between two health care facilities."
Answered by AI
Are there still open spots for this trial that participants can sign up for?
"Affirmative. The clinicaltrials.gov page indicates that this research trial is actively recruiting individuals as of April 25th, 2022. It was first posted on February 1st and requires 180 participants from 2 sites to complete the study."
Answered by AI
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