Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Alcohol Use Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic or University of Kentucky Healthcare system. Meet DSM-V criteria for alcohol use disorder. Abstinent from alcohol at the time of consent. Exclusion Criteria: Alcohol use disorder is secondary to another substance use disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Active Comparator: Group A (Intensive incentives)<br>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. | 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: Active Comparator: Group B (Prize-based incentives)<br>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. | 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: Sham Comparator: Group C (Intensive incentives)<br>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. | 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: Sham Comparator: Group D (Price-based incentives)<br>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. | 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: No Intervention: Group E (no incentives)<br>Group E will have no monitoring intervention, they will only complete assessment sessions. | |

What is the study measuring?
-----------------
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 Treatment Acceptability questionnaire will be collected during assessment sessions. Each question will be scored from 1 (low) to 4 (high) and will assess distinct components of the treatment. Questions will be interpreted and scored individually and not be summed together. | A total of 12 assessment sessions spanning over a 66 week period | 
| Time to relapse | For this outcome, we will conduct survival analyses to compare relapse across study groups. | A total of 12 assessment sessions spanning over a 66 week period |