Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Contingency management; Behavioral: Contingency Management

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40514
      • University of Kentucky HealthCare
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Virginia Tech Carilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: Group A (Intensive incentives); Group A will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will also have the opportunity to earn more incentives for providing negative results. For the first 3 weeks, these additional incentives will scale based on the number of consecutive days of sustained negative samples. For the remaining weeks incentives will be based on a randomized "prize" drawing.	Behavioral: Contingency Management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.; Other Names: Contingent incentives
Active Comparator: Active Comparator: Group B (Prize-based incentives); Group B will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will only have the opportunity to earn more incentives based on a randomized "prize" drawing if they submit a negative sample.	Behavioral: Contingency Management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.; Other Names: Contingent incentives
Sham Comparator: Sham Comparator: Group C (Intensive incentives); Group C serves as a direct control group to Group A and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.	Behavioral: Contingency management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.; Other Names: Noncontingent incentives
Sham Comparator: Sham Comparator: Group D (Price-based incentives); Group D serves as a direct control group to Group B and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.	Behavioral: Contingency management; Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.; Other Names: Noncontingent incentives
No Intervention: No Intervention: Group E (no incentives); Group E will have no monitoring intervention, they will only complete assessment sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Mikhail N Koffarnus
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 19-324; R01AA026605 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No