Telehealth Treatment for Alcohol Use Disorder

• Sponsor: Ria Health (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05747703
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), Stanford University (Other), University of Washington (Other)
• Enrollment: 124
• Arms: 2
• Anticipated Duration (Months): 17.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder; Alcohol Dependence; Alcoholism	Combination Product: Ria Treatment Platform	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: participants will be randomly assigned in a 1:1 to the Ria Treatment Platform or a waitlist control conditionparticipants will be randomly assigned in a 1:1 to the Ria Treatment Platform or a waitlist control condition
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Telehealth Intervention to Increase Screening and Treatment for Alcohol Use Disorder
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ria Treatment Platfrom 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; combined medication, coaching, education, and monitoring
No Intervention: waitlist control Patients in this arm will not be provided treatment during the study period.

Outcome Measures

Primary Outcome Measures

1. percent of subjects without heavy drinking [last four weeks]

   percent of subjects without heavy drinking per timeline follow-back

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• alcohol use disorder

Exclusion Criteria:

• inability to provide informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ria Health
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Stanford University
• University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ria Health
• ClinicalTrials.gov Identifier: NCT05747703
• Other Study ID Numbers: 1A
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alcoholism; Alcohol Drinking

Study Results

No Results Posted as of Feb 28, 2023