Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

NCT ID: NCT03942770

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2026-08-31

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. 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

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Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Comparator: Group A (Intensive incentives)

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.

Group Type ACTIVE_COMPARATOR

Contingency Management

Intervention Type BEHAVIORAL

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

Active Comparator: Group B (Prize-based incentives)

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.

Group Type ACTIVE_COMPARATOR

Contingency Management

Intervention Type BEHAVIORAL

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

Sham Comparator: Group C (Intensive incentives)

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.

Group Type SHAM_COMPARATOR

Contingency management

Intervention Type BEHAVIORAL

Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.

Sham Comparator: Group D (Price-based incentives)

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.

Group Type SHAM_COMPARATOR

Contingency management

Intervention Type BEHAVIORAL

Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.

No Intervention: Group E (no incentives)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Contingency Management

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

Intervention Type BEHAVIORAL

Contingency management

Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.

Intervention Type BEHAVIORAL

Other Intervention Names

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Contingent incentives Noncontingent incentives

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Mikhail N Koffarnus

OTHER

Sponsor Role lead

Responsible Party

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Mikhail N Koffarnus

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Kentucky Healthcare

Lexington, Kentucky, United States

Site Status

Virginia Tech Carilion

Roanoke, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA026605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-324

Identifier Type: -

Identifier Source: org_study_id