Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

Study Overview
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Brief Summary
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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.

Official Title
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Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Contingency management
* Behavioral: Contingency management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back. Must endorse alcohol as their primary drug of use. Express a desire to abstain from drinking. Exclusion Criteria: 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. Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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. | Behavioral: Contingency management<br>* Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.<br>* Other names: Contingent incentives;|
| Active Comparator: Group B<br>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. | Behavioral: Contingency management<br>* Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.<br>* Other names: Contingent incentives;|
| Sham Comparator: Group C<br>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. | Behavioral: Contingency management<br>* Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.<br>* Other names: Noncontingent incentives;|
| Sham Comparator: Group D<br>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. | Behavioral: Contingency management<br>* Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.<br>* Other names: Noncontingent incentives;|
| No Intervention: Group E<br>Group E will have no intervention, they will only complete assessment sessions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of abstinence from alcohol during intervention | Breathalyzer assessments will be collected during the treatment period. This outcome measure will consist of the percentage of days without alcohol use as detected by the breathalyzers. | up to 66 weeks | 
| Treatment acceptability | Participant ratings of treatment acceptability on a customized questionnaire will be collected during assessment sessions | A total of 12 assessment sessions spanning over a 66 week period. |