Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

Alcohol Use Disorder Clinical Trial

Official title:

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03942770
• Other study ID #: 19-324
• Secondary ID: R01AA026605
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 230
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Contingency Management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
• Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.

Locations

Country	Name	City	State
United States	University of Kentucky Healthcare	Lexington	Kentucky
United States	Virginia Tech Carilion	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Mikhail N Koffarnus	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 66 weeks
Primary	Treatment acceptability	Participant 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.	A total of 12 assessment sessions spanning over a 66 week period
Primary	Time to relapse	For this outcome, we will conduct survival analyses to compare relapse across study groups.	A total of 12 assessment sessions spanning over a 66 week period