Alcohol Use DisorderNCT07553377
A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver Disease
A study testing AcamproSync in people with Alcohol Use Disorder and Alcohol Associated Liver Disease, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Associated Liver Disease, Medications for Alcohol Use Disorder
- What is being tested?
- AcamproSync
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2027to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being treated for AUD
- Diagnosed with DSM-5 moderate to severe AUD
- Screens positive ALD utilizing non-invasive blood tests
- Planned initiation of acamprosate
Who cannot join
- History of hypersensitivity to acamprosate
- Allergy to magnesium or silver
- Severe renal impairment (creatinine clearance of 30mL/min or less)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The primary objective is to develop and examine the feasibility and acceptability of AcamproSync, an adherence intervention that combines a digital pill system (DPS) technology with personalized adherence feedback and support.
This intervention aims to improve acamprosate adherence in patients with alcohol use disorder and alcohol-associated liver disease. A pilot randomized control trial of AcamproSync compared to treatment as usual will be conducted to assess the feasibility and acceptability of the adherence intervention paired with DPS (AcamproSync). Secondarily, change in adherence, number of days drinking, and number of days abstinent will be explored. The study will take place at Yale New Haven Hospital, among people with alcohol use disorder and alcohol-associated liver disease.
- Conditions
- Alcohol Use Disorder, Alcohol Associated Liver Disease, Medications for Alcohol Use Disorder, Behavioral Medicine, Medication Adherence
- Being tested
- AcamproSync
- Medical subject headings
- Alcoholism, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamproSyncDevice
AcamproSync, 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.
| Study group | Role | What they receive |
|---|---|---|
| AcamproSync | Experimental | 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. Receives: Device: AcamproSync |
| Control (Treatment as Usual) | No intervention | Participants will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to enroll participants- Feasibility
Number of participants enrolled out of all screened.
Measured: Baseline and 30 days
Retention- Feasibility
Number of participants enrolled that complete the 30 day follow-up.
Measured: Baseline and 30 days
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.
Measured: Baseline and 30 days
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.
Measured: Baseline and 30 days
Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability
PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability.
Measured: Baseline and 30 days
Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability
Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability
Measured: Baseline and 30 days
Mean System Usability Scale (SUS) score- Usability
SUS is a reliable, 10-item questionnaire used to measure the subjective usability of products, websites, or software, producing a score from 0 to 100. Higher scores indicate more usability.
Measured: Baseline and 30 days
Secondary outcomes (7)
DPS Accuracy
Correlation coefficient between DPS recorded adherence and pill counts.
Measured: Baseline and 30 days
Heavy drinking frequency
Mean days heavy drinking in the last thirty days
Measured: Baseline and 30 days
Abstinence frequency
Mean days drinking abstinence in the last thirty days
Measured: Baseline and 30 days
Linkage to AUD treatment
Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment
Measured: Baseline and 30 days
Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R)
Mean score from 1 to 7 with higher scores indicating more severe alcohol craving.
Measured: Baseline and 30 days
Acamprosate adherence by self report
Self report pill counts at the 30 day visit
Measured: Day 30
DPS Acamprosate adherence
DPS report pill counts at the 30 day visit
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startOct 2027 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with alcohol use disorder and alcohol-associated liver disease
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Charlotte Goldfine, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553377
- Sponsor's protocol ID
- Goldfine 033126
- Other IDs
- 1K23AA032563-01
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be de-identified by removing protected identifiers. This will be clearly explained to participants as part of the human subjects consent process. The data generated through this project will be deposited into Yale Dataverse data repository and the NIAAA Data Archive (NIAAADA). Yale Dataverse is an open-access, online data repository available to investigators at Yale University. The NIAAADA a data repository hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA) for de-identified individual-level data that can be made available to the general research community.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Pill System to Measure and Support Acamprosate Adherence in Individuals With Alcohol Associated Liver Disease
- ClinicalTrials.gov ID
- NCT07553377
- Acronym / sponsor ID
- Goldfine 033126
- Conditions
- Alcohol Use Disorder, Alcohol Associated Liver Disease, Medications for Alcohol Use Disorder, Behavioral Medicine, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2027 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to develop and examine the feasibility and acceptability of AcamproSync, an adherence intervention that combines a digital pill system (DPS) technology with personalized adherence feedback and support.
This intervention aims to improve acamprosate adherence in patients with alcohol use disorder and alcohol-associated liver disease. A pilot randomized control trial of AcamproSync compared to treatment as usual will be conducted to assess the feasibility and acceptability of the adherence intervention paired with DPS (AcamproSync). Secondarily, change in adherence, number of days drinking, and number of days abstinent will be explored. The study will take place at Yale New Haven Hospital, among people with alcohol use disorder and alcohol-associated liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with alcohol use disorder and alcohol-associated liver disease
| Arm | Type | Receives |
|---|---|---|
| AcamproSync | Experimental | Device: AcamproSyncParticipants 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. |
| Control (Treatment as Usual) | No intervention | –Participants will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being treated for AUD
- Diagnosed with DSM-5 moderate to severe AUD
- Screens positive ALD utilizing non-invasive blood tests
- Planned initiation of acamprosate
Key exclusion criteria (3 listed)
- History of hypersensitivity to acamprosate
- Allergy to magnesium or silver
- Severe renal impairment (creatinine clearance of 30mL/min or less)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcamproSyncAcamproSync, 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. | Device | AcamproSync |
Primary outcome
Ability to enroll participants- Feasibility
Time frame: Baseline and 30 days
Number of participants enrolled out of all screened.
Retention- Feasibility
Time frame: Baseline and 30 days
Number of participants enrolled that complete the 30 day follow-up.
Feasibility of Intervention Measure (FIM)- Feasibility
Time frame: Baseline and 30 days
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
Time frame: Baseline and 30 days
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.
Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability
Time frame: Baseline and 30 days
PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability.
Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability
Time frame: Baseline and 30 days
Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability
Mean System Usability Scale (SUS) score- Usability
Time frame: Baseline and 30 days
SUS is a reliable, 10-item questionnaire used to measure the subjective usability of products, websites, or software, producing a score from 0 to 100. Higher scores indicate more usability.
7 secondary outcomes
DPS Accuracy
Time frame: Baseline and 30 days
Heavy drinking frequency
Time frame: Baseline and 30 days
Abstinence frequency
Time frame: Baseline and 30 days
Linkage to AUD treatment
Time frame: Baseline and 30 days
Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R)
Time frame: Baseline and 30 days
Acamprosate adherence by self report
Time frame: Day 30
DPS Acamprosate adherence
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. Raw data will be de-identified by removing protected identifiers. This will be clearly explained to participants as part of the human subjects consent process. The data generated through this project will be deposited into Yale Dataverse data repository and the NIAAA Data Archive (NIAAADA). Yale Dataverse is an open-access, online data repository available to investigators at Yale University. The NIAAADA a data repository hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA) for de-identified individual-level data that can be made available to the general research community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Goldfine principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcamproSync in people with Alcohol Use Disorder and Alcohol Associated Liver Disease, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Goldfine, MD (203-785-2353, charlotte.goldfine@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to enroll participants- Feasibility (time frame: Baseline and 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.