NCT07465588

Financial Rewards for Reducing Alcohol Use in Patients With Liver Disease

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.'

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.'

Conditions

• Alcohol Use Disorder
• Alcohol-associated Liver Disease
• Liver Cirrhosis, Alcoholic
• Alcohol-Associated Hepatitis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-03-31
• Completion: 2028-06-30
• First posted: 2026-03-12
• Last updated: 2026-03-12