MedPath

Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

Not Applicable
Conditions
Alcohol Use Disorder
Interventions
Behavioral: Contingency management
Registration Number
NCT03942770
Lead Sponsor
Mikhail N Koffarnus
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
230
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Active Comparator: Group A (Intensive incentives)Contingency managementGroup 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.
Sham Comparator: Group C (Intensive incentives)Contingency managementGroup 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.
Sham Comparator: Group D (Price-based incentives)Contingency managementGroup 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.
Active Comparator: Group B (Prize-based incentives)Contingency managementGroup 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.
Primary Outcome Measures
NameTimeMethod
Pattern of abstinence from alcohol during interventionup to 66 weeks

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.

Time to relapseA total of 12 assessment sessions spanning over a 66 week period

For this outcome, we will conduct survival analyses to compare relapse across study groups.

Treatment acceptabilityA total of 12 assessment sessions spanning over a 66 week period

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

University of Kentucky Healthcare

🇺🇸

Lexington, Kentucky, United States

Virginia Tech Carilion

🇺🇸

Roanoke, Virginia, United States

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