This study seeks to develop and test a novel digital pill system (DPS) that measures real-time medication ingestion and pairs it with a cognitive behavioral therapy (CBT)-based intervention to provide personalized, data-driven adherence support, with the long-term goal of providing new and improved personalized support and increase medication adherence for people with AUD and ALD.
Being treated for AUD
Diagnosed with DSM-5 moderate to severe AUD
Screens positive ALD utilizing non-invasive blood tests
Planned initiation of acamprosate
History of hypersensitivity to acamprosate
Allergy to magnesium or silver
Severe renal impairment (creatinine clearance of 30mL/min or less)
Parallel
AcamproSync
DeviceAcamproSync, is an innovative behavioral intervention to support acamprosate adherence in individuals with ALD. It comprises three components: 1) a digital pill system that directly measures acamprosate adherence, 2) 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.
Ability to enroll participants- Feasibility
Number of participants enrolled out of all screened.
Retention- Feasibility
Number of participants enrolled that complete the 30 day follow-up.
Feasibility of Intervention Measure (FIM)- Feasibility
Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility.
Acceptability of Intervention (AIM)- Acceptability
Treatment Acceptability will be measured using the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Total score 1-5 with higher scores indicating greater acceptability.
DPS Accuracy
Correlation coefficient between DPS recorded adherence and pill counts.
Heavy drinking frequency
Mean days heavy drinking in the last thirty days
Abstinence frequency
Mean days drinking abstinence in the last thirty days
Linkage to AUD treatment
Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
