Contingency Management for Post-Liver Transplant in Alcoholic Liver Disease

Overseen by Arpan G Patel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Arpan A. Patel, MD

Disqualifiers: Other substance use disorder, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use. The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Contingency Management for post-liver transplant in alcoholic liver disease?

Research shows that Contingency Management, which uses rewards to encourage positive behavior, has been effective in keeping people in treatment for alcohol dependence and helping them quit smoking. This suggests it could also be helpful for people recovering from a liver transplant due to alcoholic liver disease. ^{1 2 3 4 5}

Is Contingency Management safe for humans?

Contingency Management (CM) has been used safely in various studies for treating substance abuse, including alcohol and smoking, by providing incentives to encourage abstinence. These studies have shown that CM can be implemented without significant safety concerns, as it primarily involves behavioral reinforcement through rewards. ^{1 2 6 7 8}

How is the Contingency Management treatment different from other treatments for post-liver transplant in alcoholic liver disease?

Contingency Management is unique because it uses tangible rewards to encourage patients to stay sober, unlike other treatments that might focus on medication or counseling alone. This approach has been effective in treating substance abuse by reinforcing positive behaviors, such as abstaining from alcohol, through incentives. ^{5 6 9 10 11}

Research Team

Arpan G Patel, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

Willing to partake in behavioral treatment for AUD

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

I am 18 years old or older.

Exclusion Criteria

Current treatment for another substance use disorder

Unwilling to provide written informed consent

Unwilling to partake in behavioral treatment for AUD

Trial Timeline

Screening and Baseline

Participants are screened for eligibility to participate in the trial

1-2 weeks

2 visits (virtual)

Treatment

Participants receive a 10-week CM intervention or treatment as usual (TAU), with weekly virtual visits and assessments

10 weeks

10 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Contingency Management (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Contingency Management (CM) Experimental Treatment 1 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 Control 1 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. .

Who Is Running the Clinical Trial?

Arpan A. Patel, MD

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

In a study of 42 alcohol-dependent veterans, those who received contingency management (CM) alongside standard treatment had a much higher retention rate in treatment (84%) compared to those receiving only standard treatment (22%).

By the end of the 8-week treatment period, 69% of CM participants remained abstinent from alcohol, while 61% of those in standard treatment had relapsed, indicating that CM is an effective strategy for promoting abstinence in alcohol treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Give them prizes, and they will come: contingency management for treatment of alcohol dependence. Petry, NM., Martin, B., Cooney, JL., et al.[2022]

Incentive and contingency management strategies have shown effectiveness in modifying smoking behavior, particularly in controlled settings, suggesting they can be beneficial for smoking cessation efforts.

Quit-and-win programs, which use incentives to encourage quitting, attract many participants and have produced modest quit rates, although the quality of evaluations varies and more rigorous studies are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. Donatelle, R., Hudson, D., Dobie, S., et al.[2006]

Contingency management (CM) is an effective psychosocial treatment for substance use disorders that uses tangible rewards to reinforce drug-negative behaviors, showing strong efficacy based on behavioral analysis principles.

CM not only provides external rewards but may also enhance a patient's intrinsic motivation to change their substance use behavior, suggesting broader applications for this intervention beyond substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. Walter, KN., Petry, NM.[2016]

Prize-based abstinence incentives combined with standard treatment did not show significant differences in effectiveness for patients with varying treatment histories, indicating that the incentives may be equally beneficial regardless of prior treatment experience.

The study involved treatment-seeking outpatients and assessed outcomes like the longest period of abstinence and negative urine drug screens, suggesting that these incentives can be a consistent motivational tool across diverse patient backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. Killeen, T., Carter, R., Copersino, M., et al.[2019]

A systematic review of 12 randomized controlled trials involving 1654 adults found that adding cognitive-behavioral therapy (CBT) or motivational enhancement therapy (MET) to contingency management (CM) did not improve rates of abstinence from substance use at the end of treatment or during follow-up.

The analysis showed no significant benefits in secondary outcomes, such as self-reported days of substance use, indicating that CM alone is as effective as when combined with these psychotherapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. Sheridan Rains, L., Steare, T., Mason, O., et al.[2021]

A portable contingency management (CM) system using cellphones and breathalyzers was tested with 30 adults, showing that 88.6% of breath alcohol concentration (BrAC) tests were submitted on time, indicating high feasibility for this method.

Participants receiving CM had a higher percentage of negative BrAC results and longer durations of abstinence, along with reduced drinking frequency and related problems, demonstrating the initial efficacy of this approach in addressing alcohol use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. Alessi, SM., Petry, NM.[2022]

In a study of 255 substance users undergoing outpatient treatment, participants who were drug-free at the start (baseline negative) earned significantly more in contingency management (CM) incentives compared to those who were using drugs (baseline positive), with median prizes of $237 versus $44, respectively.

The findings suggest that tailoring CM interventions based on a participant's drug use status at treatment entry could enhance the effectiveness of abstinence-focused programs, as the majority of incentive expenditures were directed towards those who were already abstinent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. Cunningham, C., Stitzer, M., Campbell, AN., et al.[2019]

In a study involving 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

The cost to set up a contingency management (CM) program for treating patients with severe alcohol use disorder and serious mental illness is approximately $6,038 per site, with average treatment costs ranging from $1,119 to $1,865 per participant over 16 weeks depending on the CM version used.

This study provides a customizable costing tool that helps treatment providers estimate expenses associated with different CM designs, which can aid in budgeting and sustaining CM interventions in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. Lu, TT., Parent, SC., Chaytor, N., et al.[2023]

Contingency management (CM) is an effective treatment strategy for alcohol and other drug use disorders, focusing on reinforcing desired behaviors and discouraging undesired ones.

Human studies have shown that CM not only reduces substance use but also improves treatment attendance and helps achieve other treatment goals, such as medication compliance and employment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management. Incentives for sobriety. Higgins, ST., Petry, NM.[2022]

Contingency management (CM) effectively uses positive reinforcement to enhance treatment outcomes for substance abusers, particularly in achieving sustained abstinence from drugs.

CM is not only beneficial as a direct therapeutic approach but also serves as a valuable tool in clinical trials for testing new medications and improving patient adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management: utility in the treatment of drug abuse disorders. Stitzer, ML., Vandrey, R.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Give them prizes, and they will come: contingency management for treatment of alcohol dependence. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of motivational incentives in stimulant abusing outpatients with different treatment histories. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Improving substance misuse outcomes in contingency management treatment with adjunctive formal psychotherapy: a systematic review and meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Contingency Management Abstinence Incentives: Cost and Implications for Treatment Tailoring. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Contingency management. Incentives for sobriety. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Contingency management: utility in the treatment of drug abuse disorders. [2019]