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NCT Number: NCT05410561

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Substance Use Disorders Alcohol Drinking Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance Dependence Substance Use Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

enhanced usual care (EUC)

Behavioral

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

TeleTx intervention

Behavioral

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

Primary outcomes

  1. Alcohol Use Disorder Treatment Initiation

    Time frame: 3 months

    Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment

  2. Alcohol Use Disorder Treatment Engagement

    Time frame: 3 months

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

  3. Alcohol consumption days

    Time frame: 3-months

    Percent days of alcohol use on the Timeline Follow Back interview

  4. Alcohol consumption days

    Time frame: 6-months

    Percent days of alcohol use on the Timeline Follow Back interview

  5. Alcohol consumption days

    Time frame: 12-months

    Percent days of alcohol use on the Timeline Follow Back interview

  6. Heavy drinking days

    Time frame: 3-months

    Percent days heavy drinking on the Timeline Follow Back interview

  7. Heavy drinking days

    Time frame: 6-months

    Percent days heavy drinking on the Timeline Follow Back interview

  8. Heavy drinking days

    Time frame: 12-months

    Percent days heavy drinking on the Timeline Follow Back interview

Secondary outcomes

  1. Total Alcohol Use Disorder Psychotherapy Treatment Attendance

    Time frame: 6-months

    Total number of psychotherapy sessions

  2. Total Alcohol Use Disorder Psychotherapy Treatment Attendance

    Time frame: 12-months

    Total number of psychotherapy sessions

  3. Drinking Risk Levels (Based on World Health Organization Cut-Offs)

    Time frame: Baseline to 3-months

    Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)

  4. Drinking Risk Levels (Based on World Health Organization Cut-Offs)

    Time frame: Baseline to 6-months

    Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)

  5. Drinking Risk Levels (Based on World Health Organization Cut-Offs)

    Time frame: Baseline to 12-months

    Change in WHO drinking levels (defined by alcohol consumed per day from 1g to undefined maximum with higher amounts associated with worse outcomes)

  6. World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)

    Time frame: Baseline to 3-months

    Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.

  7. World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)

    Time frame: Baseline to 6-months

    Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.

  8. World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)

    Time frame: Baseline to 12-months

    Change in Quality of Life measure (WHO-QOL BREF). Transformed domain scores from 0 to 100. Higher scores denote better quality of life.

  9. Alcohol consequences

    Time frame: Baseline to 3-months

    Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R

  10. Alcohol consequences

    Time frame: Baseline to 6-months

    Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R

  11. Alcohol consequences

    Time frame: Baseline to 12-months

    Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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