Remote Monitoring for Alcoholism

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mikhail N Koffarnus

Disqualifiers: Alcohol treatment program, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

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.

Trial 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 (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Carilion Clinic Roanoke, VA

University of Kentucky Turfland Lexington, KY

University of Kentucky Turfland: In-person enrollment Lexington, KY

Carilion Clinic: In person-enrollment Roanoke, VA

More Trial Locations

Who Is Running the Clinical Trial?

Mikhail N Koffarnus Lead Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) Collaborator

References

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

A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. [2022] Contingency management (CM) uses tangible incentives to systematically reinforce abstinence and is among the most efficacious psychosocial substance abuse treatments. This study assessed the feasibility and initial efficacy of a portable CM procedure designed to address technical limitations for detecting drinking that have prevented using CM for alcohol problems.

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] Contingency management (CM) is a behavioral intervention in which tangible incentives are provided to patients when they achieve a desired behavior (e.g., reducing or abstaining from alcohol use). The authors sought to describe the resource requirements and associated costs of various CM versions (usual, high magnitude, and shaping) tailored to a high-risk population with co-occurring serious mental illness and severe alcohol use disorder.

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] Contingency management (CM) interventions have gained considerable interest due to their success in the treatment of addiction. However, their implementation can be resource-intensive for clinical staff. Mobile telephone-based systems might offer a low-cost alternative. This approach could facilitate remote monitoring of behaviour and delivery of the reinforcer and minimize issues of staffing and resources. This systematic review and meta-analysis assessed the evidence for the effectiveness of mobile telephone-delivered CM interventions to promote abstinence (from drugs, alcohol and tobacco), medication adherence and treatment engagement among individuals with substance use disorders.

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

A systematic review of remotely delivered contingency management treatment for substance use. [2023] Substance use and related consequences (e.g., impaired driving, injuries, disease transmission) continue to be major public health concerns. Contingency management (CM) is a highly effective treatment for substance use disorders. Yet CM remains vastly underutilized, in large part due to implementation barriers to in-person delivery. If feasible and effective, remote delivery of CM may reduce barriers at both the clinic- and patient-level, thus increasing reach and access to effective care. Here, we summarize data from a systematic review of studies reporting remote delivery of CM for substance use treatment.

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

Contingency management: utility in the treatment of drug abuse disorders. [2019] Contingency management (CM) is a strategy that uses positive reinforcement to improve the clinical outcomes of substance abusers in treatment, especially sustained abstinence from drugs of abuse. Further, CM has been adopted to improve methodology and interpretation of outcomes in clinical trials testing new pharmacotherapies and to improve adherence to efficacious medications in substance abuse patients. Thus, CM has proven to be widely useful as a direct therapeutic intervention and as a tool in treatment development.

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] Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers.

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

Contingency management for alcohol use reduction: a pilot study using a transdermal alcohol sensor. [2022] Contingency management (CM) has not been thoroughly evaluated as a treatment for alcohol abuse or dependence, in part because verification of alcohol use reduction requires frequent in-person breath tests. Transdermal alcohol sensors detect alcohol regularly throughout the day, providing remote monitoring and allowing for rapid reinforcement of reductions in use.

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] Alcohol Use Disorder (AUD) is the most prevalent substance use disorder in the United States and is directly related to 5% of all annually reported deaths worldwide. Contingency Management (CM) is among the most effective interventions for AUD, with recent technological advancements allowing CM to be provided remotely. Objective: To evaluate the feasibility and acceptability of a mobile Automated Reinforcement Management System (ARMS) designed to provide CM for AUD remotely. Methods: Twelve participants with mild or moderate AUD were exposed to ARMS in a A-B-A within-subject experimental design where they were required to submit three breathalyzer samples per day. During the B phase participants could earned rewards with monetary value for submitting negative samples. Feasibility was determined by the proportion of samples submitted and retention in the study and acceptability was based on participants self-reported experience. Results: The mean number of samples submitted per day was 2.02 out of 3. The proportion of samples submitted in each phase was 81.5%, 69.4% and 49.4%, respectively. Participants were retained for a mean of 7.5 (SD=1.1) out of 8 weeks with 10 participants (83.3%) completing the study. All participants found the app easy to use and stated it helped them reduce their alcohol use. Eleven (91.7%) would recommend the app as an adjunct to AUD treatment. Preliminary indicators of efficacy are also presented. Conclusions: ARMS has shown to be feasible and well accepted. If shown effective, ARMS can serve as an adjunctive treatment for AUD.

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

Technology-Based Contingency Management in the Treatment of Substance-Use Disorders. [2023] Contingency management is one of the most efficacious interventions to promote drug abstinence. Contingency management has traditionally been delivered in person so that clinicians could confirm drug abstinence and provide access to additional therapeutic services. Now, new technologies not only permit remote confirmation of abstinence, but also remote delivery of incentives. We discuss several technology-based tools to assess substance use, and new ways to deliver contingency management to promote tobacco, alcohol, and cannabis abstinence. These new tools have the potential to dramatically increase access while maintaining high levels of treatment fidelity. Technology-based methods also allow arranging group contingencies that harness online communities, and they permit targeting multiple health-risk behaviors with a combination of sensor-based technologies. Overall, there are unprecedented opportunities to link technology with contingency management to promote drug abstinence.