Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

Substance Use Disorders Clinical Trial

Official title:

Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410561
• Other study ID #: HUM00204315
• Secondary ID: 1R01AA029400-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Carly Brin, LMSW
• Phone: 734-552-6695
• Email: brinca[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to test new programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The program sessions focus on getting to know what's important to the participants, reviewing or setting goals, and using different skills and behaviors to better manage health. The trial will help the study team learn about ways to deliver health information in a way that is useful and interesting. This research will take place remotely (e.g., Zoom, Facetime, Phone) and participants will be randomized to the Telehealth (TeleTx) group intervention or the Enhanced Usual Care (EUC) control group. Both groups will be asked to have follow-up visits up to 12 months from the baseline visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Current Diagnostic and Statistical Manual (DSM) -5 alcohol use disorder (AUD) based on alcohol symptom checklist
• An average of 3 or more drinking days per week for the past 30 days
• Have regular access to a device with video capabilities or a phone to use for study related calls

Exclusion Criteria:

• Inability to speak or understand English
• Conditions that preclude informed consent or understanding of assessment or intervention content
• Past 90-day AUD psychotherapy treatment,
• At elevated risk for complicated alcohol withdrawal
• Past-year drug injection.

Related Conditions & MeSH terms

• Alcoholism
• Substance Dependence
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Enhanced Usual Care (EUC)
EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.
• TeleTx intervention
TeleTx will consist of an initial session and then 8 ~counseling sessions.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	VA Ann Arbor Health Care | Veterans Affairs	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	Alcohol Use Disorder Treatment Initiation	Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment	3 months
Primary	Alcohol Use Disorder Treatment Engagement	Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions	3 months
Primary	Alcohol consumption days	Percent days of alcohol use on the Timeline Follow Back interview	3-months
Primary	Alcohol consumption days	Percent days of alcohol use on the Timeline Follow Back interview	6-months
Primary	Alcohol consumption days	Percent days of alcohol use on the Timeline Follow Back interview	12-months
Primary	Heavy drinking days	Percent days heavy drinking on the Timeline Follow Back interview	3-months
Primary	Heavy drinking days	Percent days heavy drinking on the Timeline Follow Back interview	6-months
Primary	Heavy drinking days	Percent days heavy drinking on the Timeline Follow Back interview	12-months
Secondary	Total Alcohol Use Disorder Psychotherapy Treatment Attendance	Total number of psychotherapy sessions	6-months
Secondary	Total Alcohol Use Disorder Psychotherapy Treatment Attendance	Total number of psychotherapy sessions	12-months
Secondary	Drinking Risk Levels (Based on World Health Organization Cut-Offs)	Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)	Baseline to 3-months
Secondary	Drinking Risk Levels (Based on World Health Organization Cut-Offs)	Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)	Baseline to 6-months
Secondary	Drinking Risk Levels (Based on World Health Organization Cut-Offs)	Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)	Baseline to 12-months
Secondary	World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)	Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.	Baseline to 3-months
Secondary	World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)	Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.	Baseline to 6-months
Secondary	World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)	Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.	Baseline to 12-months
Secondary	Alcohol consequences	Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R	Baseline to 3-months
Secondary	Alcohol consequences	Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R	Baseline to 6-months
Secondary	Alcohol consequences	Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R	Baseline to 12-months