Contingency Management for Alcoholism

(Peth Trial)

Overseen By Ruth Fetter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Disqualifiers: Condition hindering participation

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Contingency Management for Alcoholism is an effective treatment?

The available research shows that Contingency Management (CM) is effective in treating alcoholism. In one study, 84% of participants who received CM stayed in treatment for 8 weeks, compared to only 22% of those who received standard treatment. This suggests that CM helps people stick with their treatment plans better than standard care. Another study highlights that CM is one of the most effective treatments for promoting abstinence from alcohol by using tangible rewards to encourage positive behavior. ^{1 2 3 4 5}

What safety data exists for Contingency Management in treating alcoholism?

The provided research does not directly address safety data for Contingency Management (CM) in treating alcoholism. However, CM is described as an evidence-based intervention that improves treatment outcomes for substance use disorders, including alcohol use. The studies discuss its implementation, resource requirements, and efficacy, but do not specifically mention safety concerns or data. Further research specifically focused on safety would be needed to answer this question comprehensively. ^{2 3 6 7 8}

Is Contingency Management a promising treatment for alcoholism?

Yes, Contingency Management is a promising treatment for alcoholism. It uses rewards to encourage people to reduce or stop drinking, and has been shown to be effective in helping people stay away from alcohol. It's also a low-cost and adaptable approach that can be used in different communities. ^{2 3 7 9 10}

Research Team

Sheila Alessi, Ph.D.

Principal Investigator

UConn Health

Eligibility Criteria

This trial is for individuals with an alcohol use disorder who are starting intensive outpatient treatment. It's not suitable for those with conditions that could interfere with their participation in the study.

Inclusion Criteria

You have been diagnosed with a drinking problem by a mental health professional.

I am currently in a rigorous outpatient treatment program.

Exclusion Criteria

You have a medical condition that may make it difficult for you to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive outpatient treatment for alcohol use disorders with PEth monitoring every 3 weeks for 12 weeks. Participants are assigned to either standard care or standard care plus contingency management.

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on alcohol abstinence and group attendance.

12 months

Treatment Details

Interventions

• Contingency management
• Standard care

Trial Overview The study tests if adding a reward system (Contingency Management) to standard care improves attendance and reduces alcohol consumption in patients. Participants will either receive standard care or standard care plus rewards for attending treatment and providing alcohol-free blood samples.

Participant Groups

Group I: Experimental Group Experimental Treatment 2 Interventions

Standard care plus contingency management

Group II: Control Group Active Control 1 Intervention

Standard care

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

Approved in United States as Contingency Management for:

• Alcohol dependence
• Substance use disorders

Approved in European Union as Contingency Management for:

• Alcohol dependence
• Substance use disorders

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Contingency management (CM) interventions have been shown to effectively increase physical activity and medication adherence in various medical conditions, based on a review of 24 randomized studies.

The positive effects of CM tend to diminish once the reinforcement is removed, indicating the need for ongoing support to maintain these health behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for individuals with chronic health conditions: A systematic review and meta-analysis of randomized controlled trials. Ellis, JD., Struble, CA., Fodor, MC., et al.[2021]

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]

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 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]

In a 12-week study involving 161 adults with alcohol dependence, higher-magnitude contingency management (CM-H) significantly reduced the average number of positive breath samples, indicating less alcohol use during the intervention.

Participants in the CM-H group had a higher rate of abstinence during follow-up, suggesting that home-based CM with sufficient incentives can effectively support long-term abstinence from alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Contingency Management Delivered by Community Health Workers to Improve Alcohol Abstinence: A Randomized Control Trial. Jirapramukpitak, T., Pattanaseri, K., Chua, KC., et al.[2020]

Contingency management (CM) has been effectively implemented at a large U.S. Department of Veterans Affairs Addiction Treatment Center to encourage abstinence from substance use, highlighting its role as an evidence-based intervention.

The implementation faced challenges such as staff acceptance, initial referral limitations, and the need for proper training and resources, but local innovations have helped expand CM since its introduction in 2012.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Contingency Management at a Large VA Addiction Treatment Center. Ruan, H., Bullock, CL., Reger, GM.[2018]

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) interventions have been shown to consistently improve treatment outcomes for substance abuse, but they are rarely used in practice due to various concerns.

The article reviews common criticisms of CM, including philosophical, motivational, durability, and economic issues, and suggests ways to address these concerns to enhance the implementation of this effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? Petry, NM., Alessi, SM., Olmstead, TA., et al.[2019]

Contingency management (CM) is a culturally acceptable and feasible approach for treating alcohol use disorders among American Indian and Alaska Native (AI/AN) communities, emphasizing the need for culturally specific and practical reinforcers like art supplies and transportation assistance.

The success of the CM intervention is enhanced when it is supported by respected community members, such as Elders, and incorporates local language and cultural symbols, aligning with AI/AN values and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focus groups to increase the cultural acceptability of a contingency management intervention for American Indian and Alaska Native Communities. Hirchak, KA., Leickly, E., Herron, J., et al.[2020]

A group-based contingency management (CM) intervention for HIV-positive patients with cocaine or opioid use disorders led to significantly more consecutive drug-free urine samples compared to a 12-step (TS) group, indicating its effectiveness in promoting abstinence during treatment.

CM participants also experienced greater reductions in viral loads and HIV-risk behaviors from pre- to post-treatment, although these benefits were not sustained in the long term, highlighting the need for further research to enhance lasting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based randomized trial of contingencies for health and abstinence in HIV patients. Petry, NM., Weinstock, J., Alessi, SM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Contingency management for individuals with chronic health conditions: A systematic review and meta-analysis of randomized controlled trials. [2021]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Home-Based Contingency Management Delivered by Community Health Workers to Improve Alcohol Abstinence: A Randomized Control Trial. [2020]

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

Implementation of Contingency Management at a Large VA Addiction Treatment Center. [2018]

7. 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]

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

Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? [2019]

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

Focus groups to increase the cultural acceptability of a contingency management intervention for American Indian and Alaska Native Communities. [2020]

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

Group-based randomized trial of contingencies for health and abstinence in HIV patients. [2021]