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Active, Not Recruiting

NCT Number: NCT03883126

Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Online Enrollment from the Unversity of Kentucky, Lexington, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Contingency Management

Behavioral

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

Other names: Contingent incentives

Primary outcomes

  1. Pattern of abstinence from alcohol during intervention

    Time frame: up to 66 weeks

    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.

  2. Treatment acceptability

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

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

Sponsors and collaborators

Lead sponsor

Mikhail N Koffarnus

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2019
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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