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

200 Participants Needed

Trial Summary

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. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.

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

Research shows that Contingency Management (CM), which uses rewards to encourage positive behavior like staying sober, is effective for treating substance use disorders, including alcohol. Studies have found that CM can be successfully delivered remotely, making it easier for people to access this treatment. ^{1 2 3 4 5}

Is remote monitoring for alcoholism using contingency management safe for humans?

Contingency management (CM) has been used safely in various studies for substance use disorders, including alcohol and smoking, without significant safety concerns reported. It involves providing incentives for desired behaviors, and studies have shown it to be a safe behavioral intervention. ^{1 2 4 6 7}

How is the treatment Contingency Management unique for alcoholism?

Contingency Management is unique because it uses rewards to encourage alcohol abstinence, and recent advancements allow it to be delivered remotely through mobile apps, making it more accessible and less resource-intensive compared to traditional in-person methods. ^{1 3 4 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. 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]

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

Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis. [2021]

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

A systematic review of remotely delivered contingency management treatment for substance use. [2023]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Contingency management for alcohol use reduction: a pilot study using a transdermal alcohol sensor. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Technology-Based Contingency Management in the Treatment of Substance-Use Disorders. [2023]