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Active, not recruitingNCT03883126Updated Apr 6, 2026

Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

An interventional study of Contingency management and Contingency management in Alcohol Use Disorder, sponsored by Mikhail N Koffarnus. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Mikhail N Koffarnus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Alcohol Use Disorder

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03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 211 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Mikhail N Koffarnus is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
211 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: Contingency management

  • Active comparator
    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.

    Behavioral: Contingency management

  • Sham comparator
    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.

    Behavioral: Contingency management

  • Sham comparator
    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.

    Behavioral: Contingency management

  • No intervention
    Group E

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

Interventions

  • BehavioralContingency management

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

    Also known as: Contingent incentives

  • BehavioralContingency management

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

    Also known as: Noncontingent incentives

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 66 weeks

  2. Treatment acceptability

    Participant ratings of treatment acceptability on a customized questionnaire will be collected during assessment sessions

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

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Study locations

3 sites
  • Nationwide Online Enrollment from the Unversity of Kentucky
    Lexington, Kentucky 40504, United States
  • University of Kentucky Turfland: In-person enrollment
    Lexington, Kentucky 40504, United States
  • Carilion Clinic: In person-enrollment
    Roanoke, Virginia 24014, United States
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References and documents

Individual participant data

Plan to share: Yes — Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03883126
Lead sponsor
Mikhail N Koffarnus
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Mikhail N Koffarnus (Associate Professor, University of Kentucky) — Sponsor-investigator
First posted
Mar 20, 2019
Start date
Jun 16, 2020
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Apr 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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