NCT05747703

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2024Sep 2026

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 17, 2023

Last Update Submit

February 11, 2026

Conditions

Alcohol Use DisorderAlcohol DependenceAlcoholism

Outcome Measures

Primary Outcomes (1)

  • percent of subjects without heavy drinking

    percent of subjects without heavy drinking per timeline follow-back

    last four weeks

Study Arms (2)

Ria Treatment Platfrom

EXPERIMENTAL

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.

Combination Product: Ria Treatment Platform

waitlist control

NO INTERVENTION

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

Interventions

Ria Treatment PlatformCOMBINATION_PRODUCT

combined medication, coaching, education, and monitoring

Ria Treatment Platfrom

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • alcohol use disorder

You may not qualify if:

  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John Mendelson, MD

    Ria Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants will be randomly assigned in a 1:1 to the Ria Treatment Platform or a waitlist control condition
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

January 31, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

US(1)