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Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03942770
Enrollment
91
Registered
2019-05-08
Start date
2019-07-15
Completion date
2026-08-31
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

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. 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.

Interventions

BEHAVIORALContingency Management

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

BEHAVIORALContingency management

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

Sponsors

Mikhail N Koffarnus
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pattern of abstinence from alcohol during interventionup to 66 weeksBreathalyzer 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.
Treatment acceptabilityA total of 12 assessment sessions spanning over a 66 week periodParticipant ratings of treatment acceptability on a customized Treatment Acceptability questionnaire will be collected during assessment sessions. Each question will be scored from 1 (low) to 4 (high) and will assess distinct components of the treatment. Questions will be interpreted and scored individually and not be summed together.
Time to relapseA total of 12 assessment sessions spanning over a 66 week periodFor this outcome, we will conduct survival analyses to compare relapse across study groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026