Alcohol Use Disorder (AUD)NCT07922590
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
A study testing Text Message (to remind of Integrated Plan content) in people with Alcohol Use Disorder (AUD) and Suicide Ideation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will develop and evaluate a brief, personalized, single-session telehealth intervention combined with a four-week just-in-time adaptive intervention (JITAI) delivered via text messaging for adults with alcohol use disorder (AUD) and suicidal thoughts and behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD), Suicide Ideation
- What is being tested?
- Text Message (to remind of Integrated Plan content)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Jul 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Meets DSM-5 criteria for current (past 6 months) Alcohol Use Disorder (mild, moderate, or severe)
- Reports at least one episode of suicidal ideation in the past 6 months
- Currently engaged in alcohol use treatment (at least monthly participation in outpatient or intensive outpatient individual or group treatment)
- Alcohol identified as primary substance of use
- Resides in the United States
Show all 9Show fewer
- Owns a personal smartphone
- Able and willing to provide informed consent
- Co-occurring mood disorders (excluding bipolar disorder), anxiety disorders, or other substance use disorders are permitted
Who cannot join
- Current suicidal or homicidal intent
- Suicide attempt within the past 3 months
- Psychiatric hospitalization within the past 3 months
- Current or past psychotic disorder or bipolar disorder
- Alcohol withdrawal requiring medical management (e.g., CIWA-Ar score > 8)
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401
Margaret M Baer, PhD, 567-218-3067, baerm@musc.edu
About this study
Official title: A Micro-Randomized Trial to Optimize a Just-in-Time Adaptive Intervention for Alcohol Craving and Suicide Ideation
This study will develop and evaluate a brief, personalized, single-session telehealth intervention combined with a four-week just-in-time adaptive intervention (JITAI) delivered via text messaging for adults with alcohol use disorder (AUD) and suicidal thoughts and behaviors. The study includes qualitative interviews, pilot testing, and a 28-day micro-randomized trial (MRT). In the MRT phase, participants (N=75) will be repeatedly randomized multiple times per day to receive text messages targeting craving and suicide ideation or to receive no message. Outcomes include alcohol craving, suicide ideation, alcohol consumption, and engagement with intervention strategies
- Conditions
- Alcohol Use Disorder (AUD), Suicide Ideation
- Being tested
- Text Message (to remind of Integrated Plan content)
- Keywords
- alcohol, suicidal thoughts, text message
- Medical subject headings
- Alcoholism, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message (to remind of Integrated Plan content)Behavioural
At four time points each day (112 time points across the 28-day study), each participant will be randomized to text message or no text message. Within the text message condition, there will be further randomization to Text Message Choice and Text Message Language conditions.
| Study group | Role | What they receive |
|---|---|---|
| Single arm. Groups of people are not randomized. Each person is repeated randomized. | Experimental | Groups of people are not randomized. Each person is repeated randomized 112 times over 28 days to text message vs no text message. Within the text message condition, there is additional randomization to text message choice and text message language conditions. Receives: Behavioral: Text Message (to remind of Integrated Plan content) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated Plan Engagement
Participants will complete the following yes/no EMA item four times a day: "Since the last survey, I completed a strategy from my Integrated Plan." This item, created by the study team for this study, will assess the completion of any intervention strategy from the patient's individualized Integrated Plan during the 28 day period.
Measured: 28-day MRT period
Alcohol Craving
Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about drinking or how good a drink would make me feel." This item, drawn from a well-established measure of alcohol craving (Penn Alcohol Craving Scale) will assess craving during the 28 day period.
Measured: 28-day MRT period
Suicide Ideation
Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about killing myself." This item, drawn from a well-established interview that has also been used as a self-report measure to assess varied self-injurious thoughts and behaviors (Self-Injurious Thoughts and Behaviors Interview-Revised) will assess thoughts of suicide during the 28 day period. This item has been used previously by the PI in EMA studies.
Measured: 28-day MRT period
Secondary outcomes (1)
Alcohol Consumption
Participants will complete the following EMA item to assess alcohol consumption four times a day: "Since the last survey, I drank __ drinks".
Measured: 28-day MRT period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Microrandomized control trial. Each participant receives a single session intervention with a provider and is then randomized over and over for a 28-day period to different intervention text options.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Margaret M Baer, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922590
- Sponsor's protocol ID
- Pro00151349
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Micro-Randomized Trial to Optimize a Just-in-Time Adaptive Intervention for Alcohol Craving and Suicide Ideation
- ClinicalTrials.gov ID
- NCT07922590
- Acronym / sponsor ID
- Pro00151349
- Conditions
- Alcohol Use Disorder (AUD), Suicide Ideation
- Keywords
- alcohol, suicidal thoughts, text message
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 6 Nov 2026 (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.
This study will develop and evaluate a brief, personalized, single-session telehealth intervention combined with a four-week just-in-time adaptive intervention (JITAI) delivered via text messaging for adults with alcohol use disorder (AUD) and suicidal thoughts and behaviors. The study includes qualitative interviews, pilot testing, and a 28-day micro-randomized trial (MRT). In the MRT phase, participants (N=75) will be repeatedly randomized multiple times per day to receive text messages targeting craving and suicide ideation or to receive no message. Outcomes include alcohol craving, suicide ideation, alcohol consumption, and engagement with intervention strategies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Microrandomized control trial. Each participant receives a single session intervention with a provider and is then randomized over and over for a 28-day period to different intervention text options.
| Arm | Type | Receives |
|---|---|---|
| Single arm. Groups of people are not randomized. Each person is repeated randomized. | Experimental | Behavioral: Text Message (to remind of Integrated Plan content)Groups of people are not randomized. Each person is repeated randomized 112 times over 28 days to text message vs no text message. Within the text message condition, there is additional randomization to text message choice and text message language conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older
- Meets DSM-5 criteria for current (past 6 months) Alcohol Use Disorder (mild, moderate, or severe)
- Reports at least one episode of suicidal ideation in the past 6 months
- Currently engaged in alcohol use treatment (at least monthly participation in outpatient or intensive outpatient individual or group treatment)
- Alcohol identified as primary substance of use
Key exclusion criteria (6 listed)
- Current suicidal or homicidal intent
- Suicide attempt within the past 3 months
- Psychiatric hospitalization within the past 3 months
- Current or past psychotic disorder or bipolar disorder
- Alcohol withdrawal requiring medical management (e.g., CIWA-Ar score > 8)
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 |
|---|---|---|
| Text Message (to remind of Integrated Plan content)At four time points each day (112 time points across the 28-day study), each participant will be randomized to text message or no text message. Within the text message condition, there will be further randomization to Text Message Choice and Text Message Language conditions. | Behavioural | Single arm. Groups of people are not randomized. Each person is repeated randomized. |
Primary outcome
Integrated Plan Engagement
Time frame: 28-day MRT period
Participants will complete the following yes/no EMA item four times a day: "Since the last survey, I completed a strategy from my Integrated Plan." This item, created by the study team for this study, will assess the completion of any intervention strategy from the patient's individualized Integrated Plan during the 28 day period.
Alcohol Craving
Time frame: 28-day MRT period
Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about drinking or how good a drink would make me feel." This item, drawn from a well-established measure of alcohol craving (Penn Alcohol Craving Scale) will assess craving during the 28 day period.
Suicide Ideation
Time frame: 28-day MRT period
Participants will complete the following EMA item (on a 0-10 Likert scale) four times a day: "Since the last survey, I thought about killing myself." This item, drawn from a well-established interview that has also been used as a self-report measure to assess varied self-injurious thoughts and behaviors (Self-Injurious Thoughts and Behaviors Interview-Revised) will assess thoughts of suicide during the 28 day period. This item has been used previously by the PI in EMA studies.
1 secondary outcome
Alcohol Consumption
Time frame: 28-day MRT period
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 6 Nov 2026.
- 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.
Margaret M Baer, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message (to remind of Integrated Plan content) in people with Alcohol Use Disorder (AUD) and Suicide Ideation, run by Medical University of South Carolina 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 9 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Nov 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?
Contact Margaret M Baer, PhD (567-218-3067, baerm@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated Plan Engagement (time frame: 28-day MRT period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.