Financial Rewards for Reducing Alcohol Use in Patients With Liver Disease (REINFORCE)

March 10, 2026 updated by: Wei Zhang, Massachusetts General Hospital

Randomized Evaluation of Incentives FOR Clinical Effectiveness in Liver Recovery (REINFORCE Trial): A PEth-Based Contingency Management Pilot Randomized Controlled Trial for Alcohol Use Disorder in Patients With Alcohol-Associated Liver Disease

This study tests whether providing financial rewards based on a blood test result can help people with alcohol-associated liver disease (ALD) stop or reduce their drinking. The blood test is called phosphatidylethanol (PEth), which can detect alcohol use over the past three to four weeks. The financial reward program is called contingency management (CM).

The study has two parts. Part 1 involves one-time interviews and surveys with patients and healthcare providers to understand how a PEth-based CM program could best be delivered in a liver disease clinic. Part 2 is a pilot randomized controlled trial (the REINFORCE Trial) in which participants are randomly assigned to one of two groups: (1) a rewards group that receives escalating financial incentives when PEth results show reduced or no alcohol use, or (2) a monitoring group that receives fixed payments regardless of PEth results. Both groups receive PEth testing and continue their usual medical care. The study will assess whether the rewards program improves alcohol abstinence and reduction at 12 and 24 weeks.'

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Alcohol-associated liver disease (ALD) accounts for approximately 50% of liver-related deaths in the United States and is the leading indication for liver transplantation. Despite the clear benefits of alcohol use disorder (AUD) treatment, fewer than 15% of ALD patients receive any evidence-based AUD treatment. Contingency management (CM) is one of the most effective behavioral interventions for substance use disorders, providing tangible incentives contingent on verifiable behavior change. Its application in ALD has been limited by the lack of reliable alcohol monitoring methods with sufficient detection windows.

Phosphatidylethanol (PEth) is a direct alcohol biomarker with a detection window of up to four weeks, high sensitivity, and high specificity. PEth testing can now be conducted via at-home dried blood spot (DBS) sampling, reducing burden for medically complex patients. Integrating PEth-based monitoring with CM in the hepatology clinic offers a novel strategy to improve AUD treatment engagement and promote sustained alcohol abstinence in ALD patients.

Aim 1 (Months 1-9): A mixed-methods formative study enrolling 15 ALD patients and 15 hepatology/addiction providers. Semi-structured interviews and surveys will assess feasibility, acceptability, and preferences for PEth-based CM delivery, guided by the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. Findings will inform the Aim 2 intervention design.

Aim 2 (Months 7-36): A pilot randomized controlled trial (REINFORCE Trial) enrolling 90 participants with ALD and AUD (45 per arm), randomized 1:1 stratified by AUD severity and gender. The CM arm receives escalating financial incentives based on PEth results (up to $615 over 12 weeks) and treatment engagement. The control arm receives fixed non-contingent payments on the same PEth testing schedule (up to $330 over 12 weeks). Both arms receive treatment as usual. The primary outcome is alcohol abstinence at 12 weeks (PEth <8 ng/mL). Secondary outcomes include alcohol use reduction at 12 weeks, abstinence or reduction at 24 weeks, and AUD treatment engagement. Exploratory analyses will examine treatment effect modifiers including AUD severity, liver disease stage, psychiatric comorbidities, age, and gender.'

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of alcohol use disorder based on DSM 5 criteria
  • Diagnosis of alcohol associated liver disease or clinically suspected alcohol related liver injury
  • Evidence of recent alcohol use or at risk for alcohol relapse
  • Receiving care in hepatology or liver disease clinic at the participating institution
  • Willingness to undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples
  • Ability to provide informed consent
  • Willingness to participate in the contingency management intervention and follow study procedures

Exclusion Criteria:

  • Severe cognitive impairment or medical condition that prevents participation in study procedures
  • Active psychosis or severe psychiatric instability that would interfere with participation
  • Current enrollment in another contingency management program targeting alcohol use
  • Medical instability requiring hospitalization at the time of enrollment
  • Inability to communicate in English (if study materials are only available in English)
  • Any condition that, in the opinion of the investigators, would make participation unsafe or interfere with completion of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contingency Management Intervention
Participants receive a PEth based contingency management intervention designed to promote alcohol abstinence. Participants undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples. Financial incentives are provided contingent on alcohol abstinence or significant reduction in alcohol use as measured by PEth levels. The intervention lasts 12 weeks with follow up through 24 weeks.
Behavioral: PEth Based Contingency Management
Participants receive a contingency management intervention designed to promote alcohol abstinence among patients with alcohol use disorder and alcohol associated liver disease. Alcohol use is monitored using serial phosphatidylethanol (PEth) testing from dried blood spot samples. Participants receive financial incentives contingent on alcohol abstinence or substantial reduction in alcohol consumption as measured by PEth levels. Incentives escalate with consecutive negative PEth results during the 12 week intervention period.
Other Names:
  • Contingency Management for Alcohol Abstinence
Active Comparator: PEth Monitoring Control
Participants undergo the same schedule of PEth testing using dried blood spot samples but receive fixed incentives that are not contingent on alcohol use outcomes. This arm controls for monitoring and compensation while isolating the behavioral effect of contingency management.
Behavioral: PEth Monitoring with Fixed Incentives
Participants undergo serial phosphatidylethanol (PEth) testing using dried blood spot samples at the same schedule as the intervention group. Participants receive fixed incentives for completing testing visits, but incentives are not contingent on alcohol use outcomes. This condition controls for study participation, monitoring, and compensation while isolating the effect of contingency management.
Other Names:
  • PEth Monitoring Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Abstinence Measured by PEth
Time Frame: 12 weeks
Alcohol abstinence measured using phosphatidylethanol (PEth) levels obtained from dried blood spot testing. PEth is a validated biomarker of recent alcohol consumption. The primary outcome is the proportion of participants with PEth levels consistent with alcohol abstinence during the intervention period.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Alcohol Use Measured by PEth
Time Frame: Baseline to 12 weeks
Change in phosphatidylethanol (PEth) levels from baseline to the end of the intervention period, reflecting reduction in alcohol consumption.
Baseline to 12 weeks
Intervention Feasibility
Time Frame: 12 weeks
Feasibility of the contingency management intervention measured by recruitment rate, intervention completion rate, and adherence to scheduled PEth testing visits.
12 weeks
Participant Acceptability of the Intervention
Time Frame: 12 weeks
Acceptability of the contingency management intervention assessed using participant satisfaction surveys and retention in the intervention.
12 weeks
Sustained Alcohol Abstinence After Intervention
Time Frame: 24 weeks
Proportion of participants maintaining alcohol abstinence measured by PEth after completion of the intervention.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026P000556
  • 1R34AA032300-01A1 (Other Grant/Funding Number: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing plans have not yet been finalized. Individual participant data may be shared with qualified researchers in the future following completion of the study, subject to institutional review board approval, data use agreements, and applicable privacy protections.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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