Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

NCT03883126 | Active Not Recruiting DMC

• 2 other identifiers: 54073R01AA026605
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 3

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. 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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 questionnaire will be collected during assessment sessions

  A total of 12 assessment sessions spanning over a 66 week period.

Study Arms (5)

Group A

ACTIVE COMPARATOR

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.

Behavioral: Contingency management

Group B

ACTIVE COMPARATOR

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.

Behavioral: Contingency management

Group C

SHAM COMPARATOR

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.

Behavioral: Contingency management

Group D

SHAM COMPARATOR

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.

Behavioral: Contingency management

Group E

NO INTERVENTION

Group E will have no 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

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Nationwide Online Enrollment from the Unversity of Kentucky

Lexington, Kentucky, 40504, United States

Location

University of Kentucky Turfland: In-person enrollment

Lexington, Kentucky, 40504, United States

Location

Carilion Clinic: In person-enrollment

Roanoke, Virginia, 24014, 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: March 15, 2019
• First Posted: March 20, 2019
• Study Start: June 16, 2020
• 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 (3)