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Clinical Trials/NCT05410561
NCT05410561
Active, Not Recruiting
N/A

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

University of Michigan2 sites in 1 country300 target enrollmentNovember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
University of Michigan
Enrollment
300
Locations
2
Primary Endpoint
Alcohol consumption days
Status
Active, Not Recruiting
Last Updated
7 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
April 30, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allison Lin

Assistant Professor of Psychiatry

University of Michigan

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Alcohol consumption days

Time Frame: 12-months

Percent days of alcohol use on the Timeline Follow Back interview

Heavy drinking days

Time Frame: 12-months

Percent days heavy drinking on the Timeline Follow Back interview

Alcohol Use Disorder Treatment Initiation

Time Frame: 3 months

Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment

Alcohol Use Disorder Treatment Engagement

Time Frame: 3 months

Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions

Secondary Outcomes

  • Drinking Risk Levels (Based on World Health Organization Cut-Offs)(Baseline to 12-months)
  • World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)(Baseline to 12-months)
  • Alcohol consequences(Baseline to 12-months)
  • Total Alcohol Use Disorder Psychotherapy Treatment Attendance(12-months)

Study Sites (2)

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