Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Phase 1

Completed

• Conditions: Alcohol Use Disorder

• Registration Number: NCT03507075
• Lead Sponsor: Mikhail 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 feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, 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 Start: 2014-11-15
• Primary Completion: 2017-01-05
• Study Completion: 2017-01-05
• Status Verified: 2018-04
• Study First Submitted: 2018-04-07
• Study First Submitted QC: 2018-04-23
• Last Update Submitted: 2018-04-23
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• At least 18 years old
• Provide written informed consent
• Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
• Express a desire to cut down or quit drinking

Exclusion Criteria

• Pregnant or lactating
• Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
• Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
• Have immediate plans to move out of the area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent days abstinent from alcohol during intervention	Percent days abstinent is the aggregate measure throughout the 21-day intervention period	Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
Treatment acceptability	Baseline, one day after treatment end, and at a one-month follow-up	Participant ratings of treatment acceptability will be collected during assessment sessions