Monetary Incentives for Abstinence in Alcoholism

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mikhail N Koffarnus

Disqualifiers: Other substance use disorder

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

Compensation: Varies

Number of Visits: 12

Duration: 66 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cash rewards can help individuals remain sober after alcohol detox. Participants will use a smartphone app and breathalyzer to report alcohol use. Some will earn money for staying alcohol-free, while others will earn money regardless of their results or receive no rewards. This approach, known as Contingency Management (a behavioral reinforcement method), aims to determine if these incentives reduce relapse and hospital readmissions. It suits those who have recently completed an alcohol detox program and are currently not drinking. As an unphased trial, this study provides a unique opportunity to explore innovative methods for maintaining sobriety.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that contingency management, which uses rewards to encourage positive actions like staying sober, is well-received by people with substance use issues. Research from over 100 trials has proven it effective and safe in helping people reduce or quit alcohol and drug use. This method has been applied to diverse populations and has demonstrated lasting benefits. Reports of negative effects have been minimal, suggesting it is a safe option for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using monetary incentives for promoting abstinence in alcoholism because this approach harnesses behavioral economics to encourage positive behavior change. Unlike traditional treatments like counseling or medication, these methods offer tangible rewards for meeting sobriety goals, which could enhance motivation and engagement. The innovative aspect is using a prize-based system or scale incentives that grow with continued success, potentially offering a more engaging and personalized way to support individuals in their recovery journey. By directly linking financial incentives to sobriety, this method could provide immediate reinforcement, making it a promising adjunct to existing treatment options.

What evidence suggests that this trial's treatments could be effective for alcohol dependence?

Research has shown that using rewards to encourage positive behavior, known as contingency management, effectively treats alcohol use problems. In this trial, participants will divide into different groups to test various incentive strategies. Studies have found that incentives for staying sober can greatly reduce drinking. For example, a detailed 12-week program using this method showed promising results in helping people maintain sobriety. Additionally, many years of research support its success in treating various substance use issues, not just alcohol. This approach offers a practical way to help people in recovery by directly rewarding their efforts to remain abstinent. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who are currently not drinking alcohol and have recently finished or are finishing an alcohol detox program at Carilion Clinic or University of Kentucky Healthcare. Participants must meet the criteria for alcohol use disorder as per DSM-V but cannot have a primary substance use disorder other than alcohol.

Inclusion Criteria

You have a problem with alcohol use that meets the standard criteria set by the DSM-V.

Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic or University of Kentucky Healthcare system.

You have not consumed alcohol before signing up for the study.

Exclusion Criteria

Your alcohol addiction is caused by your addiction to another substance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote alcohol monitoring and incentives for abstinence, with assessments conducted via breathalyzer and smartphone app

66 weeks

12 assessment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency management
• Contingency Management

Trial Overview The study tests if adding monetary incentives for staying sober, verified through a remote breathalyzer connected to a smartphone app, can improve treatment outcomes and reduce relapse after inpatient detox compared to usual outpatient treatments.

How Is the Trial Designed?

Group I: Active Comparator: Group A (Intensive incentives) Active Control 1 Intervention

Group A will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will also have the opportunity to earn more incentives for providing negative results. For the first 3 weeks, these additional incentives will scale based on the number of consecutive days of sustained negative samples. For the remaining weeks incentives will be based on a randomized "prize" drawing.

Group II: No Intervention: Group E (no incentives) Active Control 1 Intervention

Group E will have no monitoring intervention, they will only complete assessment sessions.

Group III: Active Comparator: Group B (Prize-based incentives) Active Control 1 Intervention

Group B will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will only have the opportunity to earn more incentives based on a randomized "prize" drawing if they submit a negative sample.

Group IV: Sham Comparator: Group C (Intensive incentives) Placebo Group 1 Intervention

Group C serves as a direct control group to Group A and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.

Group V: Sham Comparator: Group D (Price-based incentives) Placebo Group 1 Intervention

Group D serves as a direct control group to Group B and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.

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?

Mikhail N Koffarnus

Lead Sponsor

Trials

3

Recruited

900+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

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]

In a study involving 34 individuals with Cocaine Use Disorder, larger fixed incentives for providing negative urine samples led to faster and more effective abstinence compared to smaller incentives.

The type of incentive structure (escalating and resetting vs. fixed) did not significantly impact the overall effectiveness, suggesting that the magnitude of the incentive is more crucial for promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. Regnier, SD., Strickland, JC., Stoops, WW.[2023]

In a study involving 74 cocaine-dependent methadone outpatients over 12 weeks, both voucher and prize-based contingency management (CM) interventions led to longer durations of abstinence compared to standard treatment.

The study found no significant differences in outcomes between the voucher and prize systems, indicating that both methods are effective in promoting abstinence during treatment, which is linked to better long-term recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. Petry, NM., Alessi, SM., Hanson, T., et al.[2021]

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]

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]

A contingency management procedure that rewards participants with accumulating money for abstaining from smoking led to a significantly higher likelihood of achieving a 48-hour period of abstinence compared to a procedure that deducted money for smoking.

Participants who earned money for continued abstinence were also less likely to miss appointments, indicating better engagement and adherence to the treatment program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relative contribution of economic valence to contingency management efficacy: a pilot study. Roll, JM., Howard, JT.[2021]

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]

A study involving 120 cocaine-abusing outpatients showed that a low-cost prize reinforcement contingency management (CM) intervention significantly increased abstinence rates, especially in patients receiving up to $240 in potential rewards compared to standard treatment.

Patients who started treatment with positive urine tests responded best to the CM intervention, indicating that the effectiveness of prize reinforcement may depend on the severity of the patient's condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom? Petry, NM., Tedford, J., Austin, M., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6760431/

Contingency Management: Incentives for Sobriety - PMC Animal research provides the conceptual basis for using CM in AOD abuse treatment, and human studies have demonstrated the effectiveness of CM interventions in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01567943

Contingency Management of Alcohol Abuse in the ... The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with ...

3. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/a0cc6fcdb2968be95f60bb1c2c94eb70/contingency-management-sub-treatment.pdf

Contingency Management for the Treatment of Substance ... CM has three decades of research demonstrating its long-term efficacy for treating a variety of SUDs, including stimulant, opioid, cannabis, ...

4. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf Contingency management (CM) is a proven health care intervention with demonstrated effectiveness in treating a variety of substance use disorders (SUDs) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923001303

Implementing an evidence-based prize contingency ... This article provides planning stage guidance to support programs' adoption of evidence-based prize CM for the treatment of stimulant use disorders.

6. legislativeanalysis.org legislativeanalysis.org/wp-content/uploads/2023/10/Contingency-Management-Fact-Sheet-FINAL.pdf

Contingency Management Fact Sheet Between. 1970 and 2014, researchers conducted over 100 randomized-controlled trials demonstrating the effectiveness of contingency management in treating a ...