Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

NCT ID: NCT03883126

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

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

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. 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.

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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Group A

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.

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.

Group B

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.

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.

Group C

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.

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.

Group D

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.

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.

Group E

Group E will have no 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

* 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.
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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Nationwide Online Enrollment from the Unversity of Kentucky

Lexington, Kentucky, United States

Site Status

University of Kentucky Turfland: In-person enrollment

Lexington, Kentucky, United States

Site Status

Carilion Clinic: In person-enrollment

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

54073

Identifier Type: -

Identifier Source: org_study_id