Digital Pill System for Alcohol-Related Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new digital pill system combined with therapy to help individuals adhere to their medication for alcohol-related liver disease. The treatment, called AcamproSync, tracks medication intake and offers support using cognitive behavioral therapy techniques. The goal is to improve medication adherence and provide personalized assistance for those with alcohol use disorder and liver disease. Individuals receiving treatment for alcohol use disorder and planning to start acamprosate may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment strategies for alcohol-related liver disease.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the trial involves starting acamprosate, it's best to discuss your current medications with the trial team to ensure there are no interactions.
What prior data suggests that this digital pill system is safe for alcohol-related liver disease?
Previous studies have shown that acamprosate, the active ingredient in AcamproSync, is generally safe for people with liver problems related to alcohol use. Research indicates that most people tolerate acamprosate well, though some studies suggest it might increase hospital readmissions in patients with severe liver conditions like cirrhosis and alcohol-related hepatitis. The drug is considered safe for people with liver disease because the kidneys process it instead of the liver, reducing the risk of liver-related side effects. However, more research is needed to fully understand its long-term effects. Overall, acamprosate appears safe for many patients.12345
Why are researchers excited about this trial?
Unlike traditional treatments for alcohol-related liver disease, which mainly focus on managing symptoms and slowing disease progression, the AcamproSync system offers a fresh approach by directly measuring medication adherence. This innovative system integrates a digital pill that tracks how consistently patients take acamprosate, a medication that helps reduce alcohol cravings. Additionally, the system provides personalized cognitive-behavioral therapy interventions tailored to each individual's needs, aiming to enhance adherence and promote self-awareness of drinking patterns. Researchers are excited about this treatment because it combines technology with therapy to potentially improve patient outcomes and offer more precise management of alcohol-related liver disease.
What evidence suggests that the Digital Pill System is effective for alcohol-related liver disease?
Research has shown that acamprosate can reduce the urge to drink alcohol and lower alcohol use, potentially preventing liver disease from worsening. Studies have found that taking medications like acamprosate for at least three months can improve long-term survival for people with alcohol use disorder (AUD). Acamprosate is safe for individuals with liver disease because the kidneys, not the liver, process it. In this trial, participants in the AcamproSync arm will use the Digital Pill System, which helps track medication intake and offers personalized support through cognitive behavioral therapy (CBT). This combination aims to enhance acamprosate's effectiveness by promoting adherence to treatment plans. Meanwhile, participants in the control arm will receive standard treatment.24678
Who Is on the Research Team?
Charlotte Goldfine
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for adults being treated for moderate to severe alcohol use disorder (AUD) who also have signs of alcohol-related liver disease and are about to start taking acamprosate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the AcamproSync system, receive personalized adherence intervention, and engage in self-management through ecological momentary assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AcamproSync
Trial Overview
The study tests a digital pill system called AcamproSync, which tracks when people take their acamprosate medication and provides personalized support using cognitive behavioral therapy techniques to help them stick with treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will 1.) use the AcamproSync system which directly measures acamprosate adherence, 2) receive a personalized, adherence intervention grounded in the empiric LifeSteps Cognitive Behavioral Therapy framework and 3) self-management and introspection into alcohol use patterns through ecological momentary assessments (EMA) of drinking and alcohol craving.
Participants will receive treatment as usual.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Citations
goldfine, charlotte
Medications, such as acamprosate, have been shown to decrease alcohol craving, alcohol use, and prevent progression of liver disease; however, adherence is ...
Real-world analysis of acamprosate use in patients with ...
Acamprosate prescription was associated with higher rates of readmission in patients with cirrhosis and/or alcohol-associated hepatitis.
Acamprosate for the Treatment of Alcohol Dependence ...
They report the results of a phase 2 open-label study to investigate the safety of acamprosate in the setting of advanced liver disease.
AlcoChange: A digital therapeutic for patients with alcohol ...
Patients were recruited from inpatient and outpatient settings, and received AlcoChange therapy for 3 months. The primary outcome was reduction in alcohol use ...
A Digital Pill System to Measure and Support Acamprosate ...
This intervention aims to improve acamprosate adherence in patients with alcohol use disorder and alcohol-associated liver disease. A pilot ...
Safety of Acamprosate in Patients With Alcohol-Associated ...
Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term efficacy ...
Digital Pill System for Alcohol-Related Liver Disease
... AcamproSync will have tolerable side effects & efficacy for patients with Alcohol-Related Intimate Partner Violence, Medication Adherence, Alcoholism, Alcoholic ...
Safety of Acamprosate in Patients With Alcohol-Associated ...
Conclusion. Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term ...
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