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Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03883126
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Mikhail N Koffarnus, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Contingency management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
Actual Study Start Date : June 16, 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Group A
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.
Behavioral: Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
Other Name: Contingent incentives

Active Comparator: Group B
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.
Behavioral: Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
Other Name: Contingent incentives

Sham Comparator: Group C
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.
Behavioral: Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
Other Name: Noncontingent incentives

Sham Comparator: Group D
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.
Behavioral: Contingency management
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
Other Name: Noncontingent incentives

No Intervention: Group E
Group E will have no intervention, they will only complete assessment sessions.



Primary Outcome Measures :
  1. Pattern of abstinence from alcohol during intervention [ Time Frame: up to 66 weeks ]
    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.

  2. Treatment acceptability [ Time Frame: A total of 12 assessment sessions spanning over a 66 week period. ]
    Participant ratings of treatment acceptability on a customized questionnaire will be collected during assessment sessions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883126


Contacts
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Contact: Mikhail N Koffarnus, PhD 8593236402 koffarnus@uky.edu

Locations
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United States, Kentucky
University of Kentucky Turfland Recruiting
Lexington, Kentucky, United States, 40504
Contact: Mikhail Koffarnus, PhD         
Principal Investigator: Mikhail N Koffarnus, PhD         
Sponsors and Collaborators
Mikhail N Koffarnus
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Responsible Party: Mikhail N Koffarnus, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03883126    
Other Study ID Numbers: R01AA026605 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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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
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders