Alcohol Use DisorderREINFORCENCT07465588
Financial Rewards for Reducing Alcohol Use in Patients With Liver Disease
A study testing PEth Based Contingency Management and PEth Monitoring with Fixed Incentives in people with Alcohol Use Disorder and Alcohol-associated Liver Disease, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol-associated Liver Disease, Liver Cirrhosis, Alcoholic
- What is being tested?
- PEth Based Contingency Management and PEth Monitoring with Fixed Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.'
Read the 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
- Being tested
- PEth Based Contingency Management, PEth Monitoring with Fixed Incentives
- Keywords
- Contingency Management, Phosphatidylethanol, PEth, Dried Blood Spot, Alcohol Biomarker, Alcohol Abstinence, Hepatology, Liver Disease, Financial Incentives, Behavioral Intervention
- Medical subject headings
- Alcoholism, Liver Cirrhosis, Alcoholic, Alcohol Abstinence, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEth Based Contingency ManagementBehavioural
Also called Contingency Management for Alcohol Abstinence
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.
PEth Monitoring with Fixed IncentivesBehavioural
Also called PEth Monitoring Control
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.
| Study group | Role | What they receive |
|---|---|---|
| Contingency Management Intervention | Experimental | 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. Receives: Behavioral: PEth Based Contingency Management |
| PEth Monitoring Control | Active comparator | 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. Receives: Behavioral: PEth Monitoring with Fixed Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: Baseline to 12 weeks
Intervention Feasibility
Feasibility of the contingency management intervention measured by recruitment rate, intervention completion rate, and adherence to scheduled PEth testing visits.
Measured: 12 weeks
Participant Acceptability of the Intervention
Acceptability of the contingency management intervention assessed using participant satisfaction surveys and retention in the intervention.
Measured: 12 weeks
Sustained Alcohol Abstinence After Intervention
Proportion of participants maintaining alcohol abstinence measured by PEth after completion of the intervention.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two arm randomized controlled trial evaluating a phosphatidylethanol (PEth) based contingency management intervention for alcohol abstinence among patients with alcohol associated liver disease and alcohol use disorder. Participants will be randomized in a 1:1 ratio to either a contingency management intervention group or a control group receiving PEth monitoring with fixed incentives. The intervention period is 12 weeks with follow up through 24 weeks.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhang, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465588
- Sponsor's protocol ID
- 2026P000556
- Other IDs
- 1R34AA032300-01A1
- Acronym
- REINFORCE
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.
PubMed 31314133Beck O, Kenan Moden N, Seferaj S, Lenk G, Helander A. Study of measurement of the alcohol biomarker phosphatidylethanol (PEth) in dried blood spot (DBS) samples and application of a volumetric DBS device. Clin Chim Acta. 2018 Apr;479:38-42. doi: 10.1016/j.cca.2018.01.008. Epub 2018 Jan 5.
PubMed 29309773Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.
PubMed 37230168Petry NM, Alessi SM, Olmstead TA, Rash CJ, Zajac K. Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? Psychol Addict Behav. 2017 Dec;31(8):897-906. doi: 10.1037/adb0000287. Epub 2017 Jun 22.
PubMed 28639812Lee BP, Witkiewitz K, Mellinger J, Anania FA, Bataller R, Cotter TG, Curtis B, Dasarathy S, DeMartini KS, Diamond I, Diazgranados N, DiMartini AF, Falk DE, Fernandez AC, German MN, Kamath PS, Kidwell KM, Leggio L, Litten R, Louvet A, Lucey MR, McCaul ME, Sanyal AJ, Singal AK, Sussman NL, Terrault NA, Thursz MR, Verna EC, Radaeva S, Nagy LE, Mitchell MC. Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement. Nat Rev Gastroenterol Hepatol. 2024 Sep;21(9):626-645. doi: 10.1038/s41575-024-00936-x. Epub 2024 Jun 7.
PubMed 38849555Jett JD, Beck R, Tyutyunnyk D, Sanchez J, Weeks DL, Javors MA, Hill-Kapturczak N, Lopez-Cruzan M, Kriegel L, Ginsburg BC, Cabassa L, McDonell MG. Feasibility of a telehealth-based contingency management intervention for alcohol use disorders using the phosphatidylethanol (PEth) 16:0/18:1 alcohol biomarker: a pilot randomized trial. Am J Drug Alcohol Abuse. 2024 Mar 3;50(2):162-172. doi: 10.1080/00952990.2023.2283691. Epub 2024 Jan 29.
PubMed 38284925McDonell MG, Skalisky J, Leickly E, Orr MF, McPherson S, Roll J, Hill-Kapturczak N, Javors M. Pilot investigation of a phosphatidylethanol-based contingency management intervention targeting alcohol use. Psychol Addict Behav. 2017 Aug;31(5):608-613. doi: 10.1037/adb0000293. Epub 2017 Jul 17.
PubMed 28714726
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07465588
- Acronym / sponsor ID
- REINFORCE / 2026P000556
- Conditions
- Alcohol Use Disorder, Alcohol-associated Liver Disease, Liver Cirrhosis, Alcoholic, Alcohol-Associated Hepatitis
- Keywords
- Contingency Management, Phosphatidylethanol, PEth, Dried Blood Spot, Alcohol Biomarker, Alcohol Abstinence, Hepatology, Liver Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a two arm randomized controlled trial evaluating a phosphatidylethanol (PEth) based contingency management intervention for alcohol abstinence among patients with alcohol associated liver disease and alcohol use disorder. Participants will be randomized in a 1:1 ratio to either a contingency management intervention group or a control group receiving PEth monitoring with fixed incentives. The intervention period is 12 weeks with follow up through 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Contingency Management Intervention | Experimental | Behavioral: PEth Based Contingency ManagementParticipants 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. |
| PEth Monitoring Control | Active comparator | Behavioral: PEth Monitoring with Fixed IncentivesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEth Based Contingency ManagementAlso: Contingency Management for Alcohol AbstinenceParticipants 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. | Behavioural | Contingency Management Intervention |
| PEth Monitoring with Fixed IncentivesAlso: PEth Monitoring ControlParticipants 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. | Behavioural | PEth Monitoring Control |
Primary outcome
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.
4 secondary outcomes
Changes in Alcohol Use Measured by PEth
Time frame: Baseline to 12 weeks
Intervention Feasibility
Time frame: 12 weeks
Participant Acceptability of the Intervention
Time frame: 12 weeks
Sustained Alcohol Abstinence After Intervention
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 31314133Crabb DW, Im GY, Szabo G, Mellinger JL, Lucey MR. Diagnosis and Treatment of Alcohol-Associated Liver Diseases: 2019 Practice Guidance From the American Association for the Study of Liver Diseases. Hepatology. 2020 Jan;71(1):306-333. doi: 10.1002/hep.30866. No abstract available.
- Background: PubMed 29309773Beck O, Kenan Moden N, Seferaj S, Lenk G, Helander A. Study of measurement of the alcohol biomarker phosphatidylethanol (PEth) in dried blood spot (DBS) samples and application of a volumetric DBS device. Clin Chim Acta. 2018 Apr;479:38-42. doi: 10.1016/j.cca.2018.01.008. Epub 2018 Jan 5.
- Background: PubMed 37230168Edelman EJ, Dziura J, Deng Y, DePhilippis D, Fucito LM, Ferguson T, Bedimo R, Brown S, Marconi VC, Goetz MB, Rodriguez-Barradas MC, Simberkoff MS, Molina PE, Weintrob AC, Maisto SA, Paris M, Justice AC, Bryant KJ, Fiellin DA. Contingency management with stepped care for unhealthy alcohol use among individuals with HIV: Protocol for a randomized controlled trial. Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.
- Background: PubMed 28639812Petry NM, Alessi SM, Olmstead TA, Rash CJ, Zajac K. Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? Psychol Addict Behav. 2017 Dec;31(8):897-906. doi: 10.1037/adb0000287. Epub 2017 Jun 22.
- Background: PubMed 38849555Lee BP, Witkiewitz K, Mellinger J, Anania FA, Bataller R, Cotter TG, Curtis B, Dasarathy S, DeMartini KS, Diamond I, Diazgranados N, DiMartini AF, Falk DE, Fernandez AC, German MN, Kamath PS, Kidwell KM, Leggio L, Litten R, Louvet A, Lucey MR, McCaul ME, Sanyal AJ, Singal AK, Sussman NL, Terrault NA, Thursz MR, Verna EC, Radaeva S, Nagy LE, Mitchell MC. Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement. Nat Rev Gastroenterol Hepatol. 2024 Sep;21(9):626-645. doi: 10.1038/s41575-024-00936-x. Epub 2024 Jun 7.
- Background: PubMed 38284925Jett JD, Beck R, Tyutyunnyk D, Sanchez J, Weeks DL, Javors MA, Hill-Kapturczak N, Lopez-Cruzan M, Kriegel L, Ginsburg BC, Cabassa L, McDonell MG. Feasibility of a telehealth-based contingency management intervention for alcohol use disorders using the phosphatidylethanol (PEth) 16:0/18:1 alcohol biomarker: a pilot randomized trial. Am J Drug Alcohol Abuse. 2024 Mar 3;50(2):162-172. doi: 10.1080/00952990.2023.2283691. Epub 2024 Jan 29.
- Background: PubMed 28714726McDonell MG, Skalisky J, Leickly E, Orr MF, McPherson S, Roll J, Hill-Kapturczak N, Javors M. Pilot investigation of a phosphatidylethanol-based contingency management intervention targeting alcohol use. Psychol Addict Behav. 2017 Aug;31(5):608-613. doi: 10.1037/adb0000293. Epub 2017 Jul 17.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing PEth Based Contingency Management and PEth Monitoring with Fixed Incentives in people with Alcohol Use Disorder and Alcohol-associated Liver Disease, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhang, MD PHD (16177265925, wzhang50@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Abstinence Measured by PEth (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07465588, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.