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

NCT ID: NCT05410561

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Use Disorders Substance Use Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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TeleTx intervention

The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.

Group Type EXPERIMENTAL

TeleTx intervention

Intervention Type BEHAVIORAL

TeleTx will consist of an initial session and then 8 \~counseling sessions.

Enhanced Usual Care (EUC)

EUC will include brief psychoeducation about AUD and resources for treatment.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type BEHAVIORAL

EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.

Interventions

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Enhanced Usual Care (EUC)

EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.

Intervention Type BEHAVIORAL

TeleTx intervention

TeleTx will consist of an initial session and then 8 \~counseling sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Allison Lin

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Erin Bonar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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VA Ann Arbor Health Care | Veterans Affairs

Ann Arbor, Michigan, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Bonar EE, Goldstick JE, Rostker MJ, Dailey SE, Augustiniak AN, Brin C, Manderachia DA, Bourque C, Girard R, Sulkowski L, Lin LA. Testing a new model of telehealth-delivered treatment for primary care patients with alcohol use disorder: A randomized controlled trial protocol. Contemp Clin Trials. 2024 Jul;142:107549. doi: 10.1016/j.cct.2024.107549. Epub 2024 Apr 26.

Reference Type DERIVED
PMID: 38679140 (View on PubMed)

Other Identifiers

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1R01AA029400-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00204315

Identifier Type: -

Identifier Source: org_study_id

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