Financial Rewards for Reducing Alcohol Use in Patients With Liver Disease
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT07465588
- Status
- Not Yet Recruiting
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Conditions
- Alcohol Use Disorder
- Alcohol-Associated Hepatitis
- Alcohol-associated Liver Disease
- Liver Cirrhosis, Alcoholic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.'
Key Dates
- First listed
- Mar 12, 2026
- Start date
- Aug 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Contingency Management InterventionParticipants 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.
- Active Comparator: PEth Monitoring ControlParticipants 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.
Primary Outcome Measure
Alcohol Abstinence Measured by PEth [ Time Frame: 12 weeks ]
Central Contacts
- Wei Zhang, MD PHD16177265925
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