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.'
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
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
Parallel
PEth Based Contingency Management
BehavioralParticipants 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.
PEth Monitoring with Fixed Incentives
BehavioralParticipants 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.
Alcohol Abstinence Measured by PEth
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.
Changes in Alcohol Use Measured by PEth
Change in phosphatidylethanol (PEth) levels from baseline to the end of the intervention period, reflecting reduction in alcohol consumption.
Intervention Feasibility
Feasibility of the contingency management intervention measured by recruitment rate, intervention completion rate, and adherence to scheduled PEth testing visits.
Participant Acceptability of the Intervention
Acceptability of the contingency management intervention assessed using participant satisfaction surveys and retention in the intervention.
Sustained Alcohol Abstinence After Intervention
Proportion of participants maintaining alcohol abstinence measured by PEth after completion of the intervention.
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