Back to resultsRemote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2
Primary Purpose
Alcohol Use Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Contingency management
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
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.
Sites / Locations
- University of Kentucky Healthcare
- Virginia Tech Carilion
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Sham Comparator
No Intervention
Arm Label
Active Comparator: Group A (Intensive incentives)
Active Comparator: Group B (Prize-based incentives)
Sham Comparator: Group C (Intensive incentives)
Sham Comparator: Group D (Price-based incentives)
No Intervention: Group E (no incentives)
Arm Description
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.
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.
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.
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.
Group E will have no monitoring intervention, they will only complete assessment sessions.
Outcomes
Primary Outcome Measures
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.
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.
Time to relapse
For this outcome, we will conduct survival analyses to compare relapse across study groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT03942770
First Posted
May 6, 2019
Last Updated
October 3, 2023
Sponsor
Mikhail N Koffarnus
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03942770
Brief Title
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2
Official Title
Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikhail N Koffarnus
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: Group A (Intensive incentives)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Comparator: Group B (Prize-based incentives)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Comparator: Group C (Intensive incentives)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Sham Comparator: Group D (Price-based incentives)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
No Intervention: Group E (no incentives)
Arm Type
No Intervention
Arm Description
Group E will have no monitoring intervention, they will only complete assessment sessions.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Other Intervention Name(s)
Contingent incentives
Intervention Description
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Other Intervention Name(s)
Noncontingent incentives
Intervention Description
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
Primary Outcome Measure Information:
Title
Pattern of abstinence from alcohol during intervention
Description
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.
Time Frame
up to 66 weeks
Title
Treatment acceptability
Description
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.
Time Frame
A total of 12 assessment sessions spanning over a 66 week period
Title
Time to relapse
Description
For this outcome, we will conduct survival analyses to compare relapse across study groups.
Time Frame
A total of 12 assessment sessions spanning over a 66 week period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Kentucky Healthcare
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40514
Country
United States
Facility Name
Virginia Tech Carilion
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2
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