Remote Monitoring for Alcoholism

Recruiting at 4 trial locations

Overseen By Mikhail N Koffarnus, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mikhail N Koffarnus

Disqualifiers: Alcohol treatment program, Pregnancy, 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: 12 weeks

211 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to support individuals with alcohol dependence using a smartphone app and breathalyzer. The goal is to determine if offering monetary rewards for staying sober, tracked remotely, can help more people quit drinking. This approach, known as contingency management (a behavioral reinforcement strategy), involves providing incentives for maintaining sobriety. Participants will be divided into groups: some will receive rewards for providing negative alcohol tests, while others will receive rewards simply for submitting tests, regardless of results. This trial suits individuals who drink heavily, consider alcohol their main substance, and wish to quit. As an unphased trial, this study provides a unique opportunity to explore innovative methods for overcoming alcohol dependence.

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 this remote monitoring method is safe for alcohol dependence treatment?

Research has shown that contingency management is generally safe and well-tolerated. This method uses rewards to encourage positive actions, such as staying sober. More than 100 studies have proven its effectiveness in treating substance use problems, including alcohol dependence.

Participants in these studies did not report any serious negative side effects. The treatment focuses on providing incentives, so it involves little risk. As a behavioral approach, it does not require medication, avoiding many drug-related side effects.

Overall, evidence suggests that this method is safe for individuals dealing with alcohol dependence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of remote monitoring combined with contingency management to address alcoholism. Unlike traditional treatments like counseling or medication, this approach leverages technology to provide immediate monetary incentives for maintaining sobriety, potentially enhancing motivation and engagement. The trial also examines the impact of different incentive structures, such as rewarding timely submission of breathalyzer samples or specifically rewarding negative alcohol content, which could offer insights into optimizing behavioral reinforcement strategies. This could pave the way for more personalized and accessible treatment options for individuals struggling with alcoholism.

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

This trial will evaluate the effectiveness of using rewards to treat alcohol use disorder (AUD) through remote monitoring. Studies have shown that rewards can aid in treating AUD. In one study, 69% of participants who received rewards for staying sober did not relapse, compared to only 39% in a group without rewards. Research also indicates that individuals in these reward programs often drink less and maintain sobriety more frequently. Technology, such as smartphone apps, now enables this approach to be used remotely, allowing more people to access this proven treatment, which may lead to better outcomes for those dealing with AUD. Participants in this trial will be assigned to different groups: some will receive rewards for providing negative breathalyzer samples, others will receive rewards regardless of alcohol content, and some will have no intervention. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who drink heavily at least three times a week and want to stop drinking. They must have an alcohol use disorder with alcohol as their main substance of abuse, but not be in another treatment program or need medication for detox.

Inclusion Criteria

I want to stop drinking alcohol.

You must consider alcohol as your main drug of choice.

You have an alcohol addiction according to the DSM-5 criteria.

Exclusion Criteria

Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.

Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).

Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monetary incentives for providing breathalyzer samples over a 12-week period, with different conditions for each group.

12 weeks

Remote monitoring with daily submissions

Follow-up

Participants are monitored for safety and effectiveness after treatment

54 weeks

12 assessment sessions

What Are the Treatments Tested in This Trial?

Interventions

• Contingency management

Trial Overview The study tests if using a smartphone app and breathalyzer can help people stay away from alcohol by giving them money rewards for staying sober. This could make it easier to treat more people with alcohol dependence effectively.

How Is the Trial Designed?

Group I: Group B Active Control 1 Intervention

Group B will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner for the first 3 weeks of the intervention.For the remaining 9 weeks they will not be required to submit breathalyzer samples.

Group II: Group E Active Control 1 Intervention

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

Group III: Group A Active Control 1 Intervention

Group A will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting negative samples.

Group IV: Group D Placebo Group 1 Intervention

Group D will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will not be required to submit breathalyzer samples.

Group V: Group C Placebo Group 1 Intervention

Group C will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting on time samples regardless of alcohol content.

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

Contingency management is highly effective for promoting drug abstinence, and new technologies now allow for remote confirmation of abstinence and delivery of incentives, increasing accessibility to treatment.

These technology-based tools can assess substance use and facilitate group contingencies through online communities, potentially enhancing treatment fidelity and targeting multiple health-risk behaviors simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Based Contingency Management in the Treatment of Substance-Use Disorders. Dallery, J., Raiff, BR., Grabinski, MJ., et al.[2023]

Mobile telephone-delivered contingency management (CM) interventions significantly improve abstinence rates from tobacco and alcohol compared to control conditions, based on a systematic review of seven studies involving 222 participants.

The meta-analysis showed strong effect sizes for various outcomes, including a 94% increase in the percentage of negative samples and a 108% increase in the longest duration of abstinence, indicating that this low-cost approach can effectively support individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis. Getty, CA., Morande, A., Lynskey, M., et al.[2021]

The Automated Reinforcement Management System (ARMS) was tested with 12 participants with mild to moderate Alcohol Use Disorder (AUD) and showed high feasibility, with an average of 2.02 breathalyzer samples submitted daily and an 83.3% completion rate over 8 weeks.

Participants reported that the ARMS app was easy to use and helpful in reducing alcohol consumption, with 91.7% recommending it as a useful addition to traditional AUD treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder. Miguel, AQ., Smith, CL., Rodin, NM., et al.[2023]

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]

Remote delivery of contingency management (CM) for substance use treatment has been shown to improve outcomes such as abstinence and engagement in treatment, similar to in-person CM, based on a systematic review of 39 studies.

The majority of these studies (57.5%) were of strong quality, indicating that remote CM is not only feasible across various digital platforms but also effective in reducing barriers to treatment access for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of remotely delivered contingency management treatment for substance use. Coughlin, LN., Salino, S., Jennings, C., et al.[2023]

A study involving 13 heavy drinking adults demonstrated that contingency management (CM) effectively reduced alcohol use, as evidenced by significant declines in both self-reported abstinence and transdermal alcohol measurements over three weeks.

The use of transdermal alcohol sensors, like the SCRAM bracelet, allowed for continuous monitoring and rapid reinforcement of abstinence, highlighting its feasibility for clinical applications in treating alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for alcohol use reduction: a pilot study using a transdermal alcohol sensor. Barnett, NP., Tidey, J., Murphy, JG., et al.[2022]

In a study of 94 smokers, an internet-based contingency management program that provided financial incentives for verified abstinence significantly increased short-term smoking cessation rates at 4 weeks (39.6% abstinence) compared to a control group (13.0% abstinence).

While the initial benefits of the incentive program diminished over time, with no significant differences at 3 and 6 months, the program was well-received, particularly for its ease of use and the financial rewards, indicating its potential as an effective tool for promoting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. Dallery, J., Raiff, BR., Kim, SJ., et al.[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]

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]

Citations

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

Contingency Management: Incentives for Sobriety - PMC By the end of the treatment period, 69 percent of the patients in the contingent group had not yet experienced a relapse to alcohol use, compared with 39 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5714694/

Contingency management treatment for substance use ... Contingency management (CM) interventions consistently improve substance abuse treatment outcomes, yet CM remains a highly controversial intervention and is ...

3. case.edu case.edu/socialwork/centerforebp/sites/default/files/2024-12/CM%20for%20AUD%20full%20report-%20corrected%2012022024.pdf

CONTINGENCYMANAGEMENT... Contingency management demonstrates effectiveness for AUD treatment through reduced alcohol use and increased abstinence across diverse ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772724623000100

Feasibility study findings of an app-based contingency ... Contingency Management (CM) is among the most effective interventions for AUD, with recent technological advancements allowing CM to be provided remotely.

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6095117/

A review of contingency management for the treatment ... A review of contingency management for the treatment of substance-use disorders: adaptation for underserved populations, use of experimental technologies,

7. 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) ...

8. 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, ...

9. 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 ...