Contingency Management for Post-Liver Transplant in Alcoholic Liver Disease

Overseen By Vanessa Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arpan A. Patel, MD

Disqualifiers: Other substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 10 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a treatment called contingency management (CM) for individuals who have had a liver transplant and are drinking again. CM is a behavioral therapy that provides rewards, such as gift cards, to help reduce alcohol use. The trial will compare CM to the usual care provided after a liver transplant. It seeks individuals who have had a liver transplant and have resumed drinking within the last 60 days. Participants should be willing to try a behavioral treatment for alcohol use disorder and can complete study visits via Zoom or phone. As an unphased trial, this study offers a unique opportunity to explore a promising behavioral therapy that could enhance recovery and improve quality of life.

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 prior data suggests that contingency management is safe for post-liver transplant patients with alcohol use disorder?

Research has shown that contingency management (CM) is a safe option for people with substance use problems. CM uses rewards to encourage positive behavior, and studies have found that participants generally respond well to it. For those who misuse stimulants, incentives have led to good results without serious side effects. This suggests that CM is generally safe for similar situations, including those with alcohol use problems. Although limited information exists specifically for people who have had liver transplants, the existing research on CM's safety in other groups is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about contingency management for post-liver transplant patients with alcoholic liver disease because it offers a unique approach compared to traditional treatments, which typically involve medication and counseling. Unlike standard care, this method uses behavioral therapy with positive reinforcement, providing escalating rewards for maintaining sobriety. This approach taps into motivation by offering tangible incentives, which could enhance adherence and potentially improve long-term outcomes for transplant patients.

What evidence suggests that contingency management is effective for post-liver transplant patients with alcohol use disorder?

This trial will compare Contingency Management (CM) with Treatment As Usual (TAU) for individuals who have received a liver transplant due to alcoholic liver disease. Studies have shown that CM works well for people with substance use problems, including alcohol use disorder (AUD). CM uses rewards, like money or prizes, to motivate sobriety. Research indicates that CM can help individuals with AUD and alcohol-related liver disease (ARLD) adhere to treatment and achieve better outcomes. Early findings suggest that CM could reduce alcohol consumption after a liver transplant. Although specific evidence for alcoholic liver disease (ALD) is limited, CM has succeeded in similar contexts, offering hope for those struggling with alcohol use post-transplant. ^{6 7 8 9 10}

Who Is on the Research Team?

Arpan G Patel, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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

Has documented return to drinking (subjective or objective) within the past 30 days

Exclusion Criteria

Current treatment for another substance use disorder

Unwilling to provide written informed consent

Unwilling to partake in behavioral treatment for AUD

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

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.

How Is the Trial Designed?

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. .

Contingency Management is already approved in United States, European Union for the following indications:

Approved in United States as Contingency Management for:

• Substance Use Disorders
• Stimulant Use Disorder
• Methamphetamine Use Disorder

Approved in European Union as Contingency Management for:

• Substance Use Disorders
• Addiction Treatment

Who Is Running the Clinical Trial?

Arpan A. Patel, MD

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

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CM for Patients With ALD After Liver Transplant This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use ...

2. withpower.com withpower.com/trial/phase-alcoholism-2-2024-1e863

Contingency Management for Post-Liver Transplant in ... Trial Overview The study tests 'contingency management' (CM), a behavior therapy offering rewards for staying sober, in patients with alcoholic liver disease ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12012876/

Findings from a pilot randomized controlled trial - PMC This pilot trial explored the feasibility of contingency management to promote treatment engagement in patients with comorbid alcohol use ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06183710

Contingency Management to Incentivise Treatment ... Contingency Management to Incentivise Treatment Adherence in Alcohol-related Liver Disease. ClinicalTrials.gov ID NCT06183710.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40064640/

Findings from a pilot randomized controlled trial Overall, the CM intervention was feasible to deliver and appears promising in improving outcomes in individuals with comorbid AUD and ARLD.

6. researchgate.net researchgate.net/publication/396844307_Post_Liver_Transplant_Management_and_Outcomes_in_Alcohol-Related_Liver_Disease

Post Liver Transplant Management and Outcomes in ... Orthotopic liver transplantation is now the best therapeutic option for patients with chronic liver failure [1]. Liver transplant is now a ...

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Efficacy of Psychosocial Interventions in Inducing and ... In this study, the investigators randomized 61 patients with alcoholic cirrhosis or symptomatic alcoholic hepatitis and severe alcohol abuse ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2866424/

Motivational Incentives Research in the National Drug ... This paper reviews one such line of research, that investigating the impact of abstinence-contingent incentives on the clinical outcomes of stimulant abusers.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dar.13943

Abstracts - 2024 - Drug and Alcohol Review This study aims to compare 12-week post-release outcomes among clients referred from prison-based methadone or long-acting injectable ...

10. addictiontraining.org addictiontraining.org/documents/resources/22_2021_Clinical_Guidelines_1.12.2022_fp_th%2528003%2529.29.pdf

Clinical Guidelines The purpose of this document is to provide detailed guidelines of the Nurse Care Manager Model of Office Based Addiction Treatment program for management of ...