search
Back to results

Telehealth Treatment for Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder, Alcohol Dependence, Alcoholism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ria Treatment Platform
Sponsored by
Ria Health
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: alcohol use disorder Exclusion Criteria: inability to provide informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Ria Treatment Platfrom

    waitlist control

    Arm Description

    The Ria Treatment Platform is a telehealth approach that includes medical assessment, prescription of clinically appropriate medications for alcohol use disorder, individual and group coaching, educational video modules, and monitoring of breath alcohol concentrations through a Bluetooth-enabled breathalyzer.

    Patients in this arm will not be provided treatment during the study period.

    Outcomes

    Primary Outcome Measures

    percent of subjects without heavy drinking
    percent of subjects without heavy drinking per timeline follow-back

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    February 17, 2023
    Sponsor
    Ria Health
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA), Stanford University, University of Washington
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05747703
    Brief Title
    Telehealth Treatment for Alcohol Use Disorder
    Official Title
    A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ria Health
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA), Stanford University, University of Washington

    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
    Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder, Alcohol Dependence, Alcoholism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    participants will be randomly assigned in a 1:1 to the Ria Treatment Platform or a waitlist control condition
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ria Treatment Platfrom
    Arm Type
    Experimental
    Arm Description
    The Ria Treatment Platform is a telehealth approach that includes medical assessment, prescription of clinically appropriate medications for alcohol use disorder, individual and group coaching, educational video modules, and monitoring of breath alcohol concentrations through a Bluetooth-enabled breathalyzer.
    Arm Title
    waitlist control
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm will not be provided treatment during the study period.
    Intervention Type
    Combination Product
    Intervention Name(s)
    Ria Treatment Platform
    Intervention Description
    combined medication, coaching, education, and monitoring
    Primary Outcome Measure Information:
    Title
    percent of subjects without heavy drinking
    Description
    percent of subjects without heavy drinking per timeline follow-back
    Time Frame
    last four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: alcohol use disorder Exclusion Criteria: inability to provide informed consent

    12. IPD Sharing Statement

    Learn more about this trial

    Telehealth Treatment for Alcohol Use Disorder

    We'll reach out to this number within 24 hrs