search
Back to results

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Contingency management: Contingent incentives
Contingency management: Noncontingent incentives
Sponsored by
Mikhail 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:

  • 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

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
    April 7, 2018
    Last Updated
    April 23, 2018
    Sponsor
    Mikhail Koffarnus
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03507075
    Brief Title
    Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
    Official Title
    Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 15, 2014 (Actual)
    Primary Completion Date
    January 5, 2017 (Actual)
    Study Completion Date
    January 5, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mikhail Koffarnus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    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 determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, 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
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    69 (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
    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 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.

    Learn more about this trial

    Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

    We'll reach out to this number within 24 hrs