Substance Use DisordersNCT05410561
Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
A study testing TeleTx intervention in people with Substance Use Disorders and Substance Use, run by University of Michigan at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Substance Use Disorders, Substance Use, Substance Dependence
- What is being tested?
- TeleTx intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2022to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Health Care | Veterans Affairs
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Substance Use Disorders, Substance Use, Substance Dependence
- Being tested
- Enhanced Usual Care (EUC), TeleTx intervention
- Keywords
- Telehealth, Cognitive behavioral therapy, Psychoeducation, Motivational interviewing, Alcohol consumption
- Medical subject headings
- Substance-Related Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care (EUC)Behavioural
EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment.
TeleTx interventionBehavioural
TeleTx will consist of an initial session and then 8 ~counseling sessions.
| Study group | Role | What they receive |
|---|---|---|
| TeleTx intervention | Experimental | The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing. Receives: Behavioral: TeleTx intervention |
| Enhanced Usual Care (EUC) | Active comparator | EUC will include brief psychoeducation about AUD and resources for treatment. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Disorder Treatment Initiation
Percent of patients who initiate Alcohol Use Disorder psychotherapy treatment
Measured: 3 months
Alcohol Use Disorder Treatment Engagement
Percent of patients who attend at least 2 additional Alcohol Use Disorder psychotherapy sessions
Measured: 3 months
Alcohol consumption days
Percent days of alcohol use on the Timeline Follow Back interview
Measured: 3-months
Alcohol consumption days
Percent days of alcohol use on the Timeline Follow Back interview
Measured: 6-months
Alcohol consumption days
Percent days of alcohol use on the Timeline Follow Back interview
Measured: 12-months
Heavy drinking days
Percent days heavy drinking on the Timeline Follow Back interview
Measured: 3-months
Heavy drinking days
Percent days heavy drinking on the Timeline Follow Back interview
Measured: 6-months
Heavy drinking days
Percent days heavy drinking on the Timeline Follow Back interview
Measured: 12-months
Secondary outcomes (11)
Total Alcohol Use Disorder Psychotherapy Treatment Attendance
Total number of psychotherapy sessions
Measured: 6-months
Total Alcohol Use Disorder Psychotherapy Treatment Attendance
Total number of psychotherapy sessions
Measured: 12-months
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)
Measured: Baseline to 3-months
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)
Measured: Baseline to 6-months
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)
Measured: Baseline to 12-months
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.
Measured: Baseline to 3-months
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.
Measured: Baseline to 6-months
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.
Measured: Baseline to 12-months
Alcohol consequences
Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R
Measured: Baseline to 3-months
Alcohol consequences
Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R
Measured: Baseline to 6-months
Alcohol consequences
Change in alcohol consequences measured by the modified 17-item Short Inventory of Problem-R
Measured: Baseline to 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Nov 2022
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Allison Lin, University of Michigan
- Investigators
- Allison Lin, MD, Principal investigator, University of MichiganErin Bonar, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410561
- Sponsor's protocol ID
- HUM00204315
- Other IDs
- 1R01AA029400-01
- Status last verified
- Sep 2026
- First submitted
- 24 May 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38679140
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Telemedicine to Improve Alcohol Use Disorder Outcomes in Primary Care Patients
- ClinicalTrials.gov ID
- NCT05410561
- Acronym / sponsor ID
- HUM00204315
- Conditions
- Substance Use Disorders, Substance Use, Substance Dependence
- Keywords
- Telehealth, Cognitive behavioral therapy, Psychoeducation, Motivational interviewing, Alcohol consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TeleTx intervention | Experimental | Behavioral: TeleTx interventionThe evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)EUC will include brief psychoeducation about AUD and resources for treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual Care (EUC)EUC will comprise one session of brief psychoeducation and referral information to alcohol use disorder (AUD) treatment. | Behavioural | Enhanced Usual Care (EUC) |
| TeleTx interventionTeleTx will consist of an initial session and then 8 ~counseling sessions. | Behavioural | TeleTx intervention |
Primary outcome
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
Alcohol consumption days
Time frame: 3-months
Percent days of alcohol use on the Timeline Follow Back interview
Alcohol consumption days
Time frame: 6-months
Percent days of alcohol use on the Timeline Follow Back interview
Alcohol consumption days
Time frame: 12-months
Percent days of alcohol use on the Timeline Follow Back interview
Heavy drinking days
Time frame: 3-months
Percent days heavy drinking on the Timeline Follow Back interview
Heavy drinking days
Time frame: 6-months
Percent days heavy drinking on the Timeline Follow Back interview
Heavy drinking days
Time frame: 12-months
Percent days heavy drinking on the Timeline Follow Back interview
11 secondary outcomes
Total Alcohol Use Disorder Psychotherapy Treatment Attendance
Time frame: 6-months
Total Alcohol Use Disorder Psychotherapy Treatment Attendance
Time frame: 12-months
Drinking Risk Levels (Based on World Health Organization Cut-Offs)
Time frame: Baseline to 3-months
Drinking Risk Levels (Based on World Health Organization Cut-Offs)
Time frame: Baseline to 6-months
Drinking Risk Levels (Based on World Health Organization Cut-Offs)
Time frame: Baseline to 12-months
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
Time frame: Baseline to 3-months
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
Time frame: Baseline to 6-months
World Health Organization Quality of Life Abbreviated (WHO-QOL-BREF)
Time frame: Baseline to 12-months
Alcohol consequences
Time frame: Baseline to 3-months
Alcohol consequences
Time frame: Baseline to 6-months
Alcohol consequences
Time frame: Baseline to 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 38679140Bonar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Lin, MD principal investigator
University of Michigan
Erin Bonar, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleTx intervention in people with Substance Use Disorders and Substance Use, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Disorder Treatment Initiation (time frame: 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.