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NCT Number: NCT07465588

Financial Rewards for Reducing Alcohol Use in Patients With 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.'

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Key information

About this study

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.'

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEth Based Contingency Management

Behavioral

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

PEth Monitoring with Fixed Incentives

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Sustained Alcohol Abstinence After Intervention

    Time frame: 24 weeks

    Proportion of participants maintaining alcohol abstinence measured by PEth after completion of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhang, MD PHD

CONTACT

[email protected]

16177265925

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: REINFORCE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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