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Behavioural Intervention

Contingency Management for Post-Liver Transplant in Alcoholic Liver Disease

N/A

Recruiting

Led By Arpan G Patel, MD

Research Sponsored by Arpan A. Patel, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have received a liver transplant

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effectiveness of a behavioral treatment called 'contingency management' in patients with Alcohol-Associated Liver Disease (ALD) who have received a liver transplant. ALD is

Who is the study for?

This trial is for adults over 18 who have had a liver transplant and returned to drinking alcohol within the last month. They must be willing to undergo behavioral treatment for their alcohol use disorder and able to follow study procedures.

What is being tested?

The study tests 'contingency management' (CM), a behavior therapy offering rewards for staying sober, in patients with alcoholic liver disease post-liver transplant. Half will receive CM for 10 weeks; the other half get usual care. All interactions are via Zoom.

What are the potential side effects?

Since CM involves psychological and social interventions rather than medications, traditional side effects like those seen with drugs are not expected. However, participants may experience stress or anxiety related to adherence to the program's requirements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Non-Drinking Days

Secondary study objectives

Client Satisfaction Questionnaire-8.

Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr))

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Contingency Management (CM)Experimental Treatment1 Intervention

Study subjects who have received a liver transplant and have been randomized to the treatment arm will receive contingency management, a positive reinforcement behavioral treatment with escalating rewards for consecutive either negative urine and blood tests (or lower value of metabolites than the previous week for PeTH) depending on which results are received first, capped at a maximum of $80 (in the form of a gift card) at the week 10 visit.

Group II: Treatment As Usual (TAU)Active Control1 Intervention

Study Subjects randomized to treatment as usual (TAU) will not receive an intervention. They will continue with follow-up visits in the outpatient clinic as part of standard of care. .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contingency Management

2014

Completed Phase 4

~3440

0 / 1Eligibility criteria met