Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

NCT03942770 | Active Not Recruiting DMC

• 2 other identifiers: 19-324R01AA026605
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Active Comparator: Group A (Intensive incentives)

ACTIVE COMPARATOR

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

Active Comparator: Group B (Prize-based incentives)

ACTIVE COMPARATOR

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

Sham Comparator: Group C (Intensive incentives)

SHAM COMPARATOR

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

Sham Comparator: Group D (Price-based incentives)

SHAM COMPARATOR

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

No Intervention: Group E (no incentives)

NO INTERVENTION

Group E will have no monitoring intervention, they will only complete assessment sessions.

Interventions

Contingency management BEHAVIORAL

Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.

Also known as: Contingent incentives

Active Comparator: Group A (Intensive incentives); Active Comparator: Group B (Prize-based incentives)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Alcohol use disorder is secondary to another substance use disorder.

Sponsors & Collaborators

• Mikhail N Koffarnus: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of Kentucky Healthcare

Lexington, Kentucky, 40514, United States

Location

Virginia Tech Carilion

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: July 15, 2019
• Primary Completion: September 1, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (2)