Alcohol Use DisorderNCT05594238
Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders
A study testing Telephone Engagement, Portal Engagement and MI-CBT in people with Alcohol Use Disorder, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Telephone Engagement, Portal Engagement and MI-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 18 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AUD
- past month heavy alcohol use
- internet access
- phone access
- able to provide informed consent
Who cannot join
- inability to speak or understand English
- conditions precluding informed consent or understanding of intervention or assessment content
- recent AUD treatment
- history of or at risk for complex alcohol withdrawal
- involvement in another ongoing study for alcohol/mental health/substance use treatment
- current cancer diagnosis/ currently receiving cancer treatment (other than skin cancers)
- PI discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders (AUD)
The purpose of this research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The programs focus on getting to know what's important to participants, reviewing or setting goals, and using different skills and behaviors to manage health. The study will help researchers learn about ways to deliver health information in a way that is useful and interesting.
- Conditions
- Alcohol Use Disorder
- Being tested
- Telephone Engagement, Portal Engagement, MI-CBT
- Keywords
- Telehealth
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone EngagementBehavioural
Brief phone session with a study counselor.
Portal EngagementBehavioural
Access to a virtual portal where participant messages with study counselors.
MI-CBTBehavioural
8 one-on-one sessions done over the phone or video chat with a study counselor
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | First stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program) Receives: Behavioral: Telephone Engagement; Behavioral: MI-CBT |
| Arm B | Active comparator | First stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement Receives: Behavioral: Telephone Engagement |
| Arm C | Active comparator | First stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up Receives: Behavioral: Telephone Engagement |
| Arm D | Active comparator | First stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up Receives: Behavioral: Portal Engagement |
| Arm E | Active comparator | First stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement Receives: Behavioral: Portal Engagement |
| Arm F | Active comparator | First stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program Receives: Behavioral: Portal Engagement; Behavioral: MI-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUD Treatment Initiation
% of patients who initiate psychotherapy treatment
Measured: 4-months post-enrollment
AUD Treatment Engagement
% of patients who attend at least 2 psychotherapy treatment sessions
Measured: 4-months post-enrollment
Alcohol consumption days
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Measured: 4-months post-enrollment
Alcohol consumption days
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Measured: 8-months post-enrollment
Alcohol consumption days
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Measured: 12-months post-enrollment
Heavy drinking days
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Measured: 4-months post-enrollment
Heavy drinking days
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Measured: 8-months post-enrollment
Heavy drinking days
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Measured: 12-months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start7 Aug 2023
- Primary completion18 Jun 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
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 Alcohol Use DisorderStudies 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
- Sequential
- Model description
- Participants are first randomly assigned to two interventions: either Telephone Engagement or Portal Engagement. Participants who do not meet the criteria for response at the post-test will be re-randomized into either enhanced first stage or a Telehealth MI-CBT program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 362 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, Erin Bonar, University of Michigan
- Investigators
- Erin E Bonar, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594238
- Sponsor's protocol ID
- HUM00210546
- Other IDs
- R01AA029808
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with sponsor requirements, de-identified data will be shared with the NIAAA Data Repository, if participants agree.
Publications
Bonar EE, Kidwell K, Chapman L, Walton MA, Zheng K, Bourque C, Manderachia D, Robinson OE, Eissa AA, Dailey SE, Dolecki F Jr, Teasdale OD, NanCoff A, Chizek EE, Tyner TS, Miller AL, Lin LA. Telehealth engagement and treatment strategies for adults living with alcohol use disorder: A sequential multiple assignment randomized trial protocol. Contemp Clin Trials. 2025 Sep;156:108003. doi: 10.1016/j.cct.2025.108003. Epub 2025 Jul 9.
PubMed 40645371
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders (AUD)
- ClinicalTrials.gov ID
- NCT05594238
- Acronym / sponsor ID
- HUM00210546
- Conditions
- Alcohol Use Disorder
- Keywords
- Telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 362 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 18 Jun 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 26 Oct 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 research study is to test new technology-driven programs to see if they might help people manage their health and health behaviors related to alcohol use and well-being. The programs focus on getting to know what's important to participants, reviewing or setting goals, and using different skills and behaviors to manage health. The study will help researchers learn about ways to deliver health information in a way that is useful and interesting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Participants are first randomly assigned to two interventions: either Telephone Engagement or Portal Engagement. Participants who do not meet the criteria for response at the post-test will be re-randomized into either enhanced first stage or a Telehealth MI-CBT program.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Behavioral: Telephone Engagement, Behavioral: MI-CBTFirst stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program) |
| Arm B | Active comparator | Behavioral: Telephone EngagementFirst stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement |
| Arm C | Active comparator | Behavioral: Telephone EngagementFirst stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up |
| Arm D | Active comparator | Behavioral: Portal EngagementFirst stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up |
| Arm E | Active comparator | Behavioral: Portal EngagementFirst stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement |
| Arm F | Active comparator | Behavioral: Portal Engagement, Behavioral: MI-CBTFirst stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AUD
- past month heavy alcohol use
- internet access
- phone access
- able to provide informed consent
Key exclusion criteria (7 listed)
- inability to speak or understand English
- conditions precluding informed consent or understanding of intervention or assessment content
- recent AUD treatment
- history of or at risk for complex alcohol withdrawal
- involvement in another ongoing study for alcohol/mental health/substance use treatment
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 |
|---|---|---|
| Telephone EngagementBrief phone session with a study counselor. | Behavioural | Arm A, Arm B, Arm C |
| Portal EngagementAccess to a virtual portal where participant messages with study counselors. | Behavioural | Arm D, Arm E, Arm F |
| MI-CBT8 one-on-one sessions done over the phone or video chat with a study counselor | Behavioural | Arm A, Arm F |
Primary outcome
AUD Treatment Initiation
Time frame: 4-months post-enrollment
% of patients who initiate psychotherapy treatment
AUD Treatment Engagement
Time frame: 4-months post-enrollment
% of patients who attend at least 2 psychotherapy treatment sessions
Alcohol consumption days
Time frame: 4-months post-enrollment
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Alcohol consumption days
Time frame: 8-months post-enrollment
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Alcohol consumption days
Time frame: 12-months post-enrollment
% of days of alcohol consumption as measured by the Timeline Follow Back Interview
Heavy drinking days
Time frame: 4-months post-enrollment
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Heavy drinking days
Time frame: 8-months post-enrollment
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Heavy drinking days
Time frame: 12-months post-enrollment
% of days of heavy drinking as measured by the Timeline Follow Back Interview
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 40645371Bonar EE, Kidwell K, Chapman L, Walton MA, Zheng K, Bourque C, Manderachia D, Robinson OE, Eissa AA, Dailey SE, Dolecki F Jr, Teasdale OD, NanCoff A, Chizek EE, Tyner TS, Miller AL, Lin LA. Telehealth engagement and treatment strategies for adults living with alcohol use disorder: A sequential multiple assignment randomized trial protocol. Contemp Clin Trials. 2025 Sep;156:108003. doi: 10.1016/j.cct.2025.108003. Epub 2025 Jul 9.
- Individual participant dataSharing planned: Yes. Consistent with sponsor requirements, de-identified data will be shared with the NIAAA Data Repository, if participants agree.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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.
Erin E Bonar principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Engagement, Portal Engagement and MI-CBT in people with Alcohol Use Disorder, run by University of Michigan at 1 site 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
AUD Treatment Initiation (time frame: 4-months post-enrollment). 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 NCT05594238, 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 29 Oct 2026.