Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders

Alcohol Use Disorder Clinical Trial

Official title:

Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders (AUD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594238
• Other study ID #: HUM00210546
• Secondary ID: R01AA029808
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: September 10, 2026

Study information

• Verified date: August 2023
• Source: University of Michigan
• Contact: Lyndsay Chapman
• Phone: (734) 764-7936
• Email: lych[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The programs focus on getting to know what's important to participants, reviewing or setting goals, and using different skills and behaviors to manage health. The study will help researchers learn about ways to deliver health information in a way that is useful and interesting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 10, 2026
• Est. primary completion date: September 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• AUD

• past month heavy alcohol use

• internet access

• phone access

• able to provide informed consent

Exclusion Criteria:

• inability to speak or understand English

• conditions precluding informed consent or understanding of intervention or assessment content

• recent AUD treatment

• history of or at risk for complex alcohol withdrawal

• involvement in another ongoing study for alcohol/mental health/substance use treatment

• PI discretion

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Telephone Engagement
Brief phone session with a study counselor.
• Portal Engagement
Access to a virtual portal where participant messages with study counselors.
• MI-CBT
8 one-on-one sessions done over the phone or video chat with a study counselor

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUD Treatment Initiation	% of patients who initiate psychotherapy treatment	4-months post-enrollment
Primary	AUD Treatment Engagement	% of patients who attend at least 2 psychotherapy treatment sessions	4-months post-enrollment
Primary	Alcohol consumption days	% of days of alcohol consumption as measured by the Timeline Follow Back Interview	4-months post-enrollment
Primary	Alcohol consumption days	% of days of alcohol consumption as measured by the Timeline Follow Back Interview	8-months post-enrollment
Primary	Alcohol consumption days	% of days of alcohol consumption as measured by the Timeline Follow Back Interview	12-months post-enrollment
Primary	Heavy drinking days	% of days of heavy drinking as measured by the Timeline Follow Back Interview	4-months post-enrollment
Primary	Heavy drinking days	% of days of heavy drinking as measured by the Timeline Follow Back Interview	8-months post-enrollment
Primary	Heavy drinking days	% of days of heavy drinking as measured by the Timeline Follow Back Interview	12-months post-enrollment