Monetary Incentives for Abstinence in Alcoholism

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

230 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Contingency Management for alcoholism?

Research shows that Contingency Management (CM), which uses rewards like prizes or vouchers, helps people stay in treatment longer and achieve longer periods of not drinking. This approach has been effective for other substance use disorders, suggesting it can also be beneficial for treating alcoholism. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management (CM) is generally considered safe as it involves providing rewards for positive behavior, like abstaining from substance use, without introducing any harmful substances or procedures. ^{1 2 3 6 7}

How does the treatment Contingency Management for alcoholism differ from other treatments?

Contingency Management is unique because it uses tangible rewards, like money or prizes, to encourage people to stay sober, which is different from other treatments that might focus on counseling or medication. This approach has been effective in promoting longer periods of abstinence by providing immediate positive reinforcement for staying alcohol-free. ^{2 4 5 6 8}

What is the purpose of this trial?

Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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]

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]

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]

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

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

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

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

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

Randomized trial of contingent prizes versus vouchers in cocaine-using methadone patients. [2021]

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

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

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

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Prize reinforcement contingency management for treating cocaine users: how low can we go, and with whom? [2018]

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

The relative contribution of economic valence to contingency management efficacy: a pilot study. [2021]