Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder
• Interventions: Behavioral: Contingency management

• Registration Number: NCT03883126
• Lead Sponsor: Mikhail N Koffarnus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-20
• Study Start: 2020-06-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Contingency management	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 C	Contingency management	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 D	Contingency management	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 A	Contingency management	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.

Primary Outcome Measures

Name	Time	Method
Treatment acceptability	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
Pattern of abstinence from alcohol during intervention	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.

Trial Locations

Locations (3)

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

University of Kentucky Turfland: In-person enrollment; 🇺🇸 Lexington, Kentucky, United States

Carilion Clinic: In person-enrollment; 🇺🇸 Roanoke, Virginia, United States