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Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency management
Contingency management
Sponsored by
Mikhail N Koffarnus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nationwide Online Enrollment from the Unversity of KentuckyRecruiting
  • University of Kentucky Turfland: In-person enrollmentRecruiting
  • Carilion Clinic: In person-enrollmentRecruiting

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

Group A

Group B

Group C

Group D

Group E

Arm Description

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.

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 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 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 E will have no 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 questionnaire will be collected during assessment sessions

Secondary Outcome Measures

Full Information

First Posted
March 15, 2019
Last Updated
July 28, 2023
Sponsor
Mikhail N Koffarnus
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03883126
Brief Title
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1
Official Title
Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2020 (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
Product Manufactured in and Exported from the U.S.
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. 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.

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
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group C
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Group D
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Group E
Arm Type
No Intervention
Arm Description
Group E will have no 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 questionnaire will be collected during assessment sessions
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikhail N Koffarnus, PhD
Phone
8595332749
Email
healthful@uky.edu
Facility Information:
Facility Name
Nationwide Online Enrollment from the Unversity of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail N Koffarnus, PhD
Phone
859-533-2749
Email
healthful@uky.edu
Facility Name
University of Kentucky Turfland: In-person enrollment
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail Koffarnus, PhD
Email
healthful@uky.edu
First Name & Middle Initial & Last Name & Degree
Mikhail N Koffarnus, PhD
Facility Name
Carilion Clinic: In person-enrollment
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail Koffarnus
Email
healthful@uky.edu

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 1

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