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Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Contingency management: Contingent incentives
Contingency management: Noncontingent incentives
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years old
  • Provide written informed consent
  • Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
  • Express a desire to cut down or quit drinking
  • Be willing to pay a $75 deposit toward their incentive fund

Exclusion Criteria:

  • Pregnant or lactating
  • Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
  • Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
  • Have immediate plans to move out of the area

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Contingent

    Noncontingent

    Arm Description

    The Contingent group 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.

    The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.

    Outcomes

    Primary Outcome Measures

    Percent days abstinent from alcohol during intervention
    Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
    Treatment acceptability
    Participant ratings of treatment acceptability will be collected during assessment sessions

    Secondary Outcome Measures

    Full Information

    First Posted
    November 26, 2019
    Last Updated
    June 2, 2023
    Sponsor
    Virginia Polytechnic Institute and State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04182022
    Brief Title
    Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
    Official Title
    Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    July 10, 2019 (Actual)
    Study Completion Date
    July 10, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Virginia Polytechnic Institute and State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    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 feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.

    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
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Contingent
    Arm Type
    Active Comparator
    Arm Description
    The Contingent group 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.
    Arm Title
    Noncontingent
    Arm Type
    Sham Comparator
    Arm Description
    The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Contingency management: 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: 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
    Percent days abstinent from alcohol during intervention
    Description
    Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
    Time Frame
    Percent days abstinent is the aggregate measure throughout the 21-day intervention period
    Title
    Treatment acceptability
    Description
    Participant ratings of treatment acceptability will be collected during assessment sessions
    Time Frame
    Baseline, one day after treatment end, and at a one-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years old Provide written informed consent Meet Diagnostic and Statistical Manual criteria for alcohol use disorder Express a desire to cut down or quit drinking Be willing to pay a $75 deposit toward their incentive fund Exclusion Criteria: Pregnant or lactating Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine) Score 23 or greater on the Alcohol Withdrawal Symptom Checklist Have immediate plans to move out of the area

    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.
    Citations:
    PubMed Identifier
    34110885
    Citation
    Koffarnus MN, Kablinger AS, Kaplan BA, Crill EM. Remotely administered incentive-based treatment for alcohol use disorder with participant-funded incentives is effective but less accessible to low-income participants. Exp Clin Psychopharmacol. 2021 Oct;29(5):555-565. doi: 10.1037/pha0000503. Epub 2021 Jun 10.
    Results Reference
    derived

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    Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility

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