Alcohol Use Disorder (AUD)NCT07842588
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
A study testing CBT4CBT in people with Alcohol Use Disorder (AUD) and Suicidal Ideation, run by Mark J Rzeszutek, PhD.
Trial summary
This study will evaluate the relationship between alcohol use, suicidal thoughts and behaviors, and behavioral economic decision-making. Participants will complete surveys over approximately 12 weeks and will be randomly assigned to receive access to a self-guide computerized cognitive behavioral therapy (CBT4CBT)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD), Suicidal Ideation
- What is being tested?
- CBT4CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Aug 2029
- 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
- Consume alcohol at least weekly
- Score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
- Some interest in cutting back on drinking or quitting
- Read and understand English
- Recent active/passion ideation
Who cannot join
- Score of 31 or greater on the AUDIT
- Having unmanaged psychiatric diagnoses
- Already being in treatment for alcohol use disorder at baseline
- Past month substance use other than cannabis or tobacco
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will evaluate the relationship between alcohol use, suicidal thoughts and behaviors, and behavioral economic decision-making. Participants will complete surveys over approximately 12 weeks and will be randomly assigned to receive access to a self-guide computerized cognitive behavioral therapy (CBT4CBT) program either immediately or after a waiting period. The study will compare participants with and without recent suicidal thoughts and behaviors to better understand factors associated with alcohol use and engagement with treatment.
Read the detailed description
This randomized, 2x2 factorial study will enroll adults who drink alcohol regularly and are interested in reducing or stopping their alcohol use. Participants will complete four online assessments approximately four weeks apart over a 12 week study period. The assessments include questionnaires about alcohol use, suicidal thoughts and behaviors and behavioral economic decision-making.
Participants will be randomly assigned to receive access to Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT) program either immediately after the baseline assessment or after the second follow-up assessment. The study will compare participants with and without recent suicidal thoughts and behaviors to evaluate differences in decision-making, alcohol use, and engagement with the CBT4CBT program. The results may improve understanding of factors related to alcohol use and suicide risk and help inform future interventions for individuals with alcohol use concerns.
- Conditions
- Alcohol Use Disorder (AUD), Suicidal Ideation
- Being tested
- CBT4CBT
- 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.
CBT4CBTBehavioural
Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), a self-guided computerized cognitive behavioral therapy program for alcohol use. Participants receive access either immediately following the baseline assessment or after the second follow-up assessment.
| Study group | Role | What they receive |
|---|---|---|
| Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT | Experimental | Participants with recent suicidal thoughts or behaviors who receive immediate access to CBT4CBT. Receives: Behavioral: CBT4CBT |
| Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT | Active comparator | Participants with recent suicidal thoughts or behaviors who receive delayed access to CBT4CBT after the second follow-up assessment. Receives: Behavioral: CBT4CBT |
| No Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT | Experimental | Participants without recent suicidal thoughts or behaviors who receive immediate access to CBT4CBT. Receives: Behavioral: CBT4CBT |
| No Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT | Active comparator | Participants without recent suicidal thoughts or behaviors who receive delayed access to CBT4CBT after the second follow-up assessment. Receives: Behavioral: CBT4CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use
Change in alcohol consumption measured using the 28-day Timeline Follow-Back (TLFB).
Measured: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
Change in Suicidal Thoughts and Behaviors
Change in suicidal thoughts and behaviors as measured by the Colombia Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionAug 2029 (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.
- 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark J Rzeszutek, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark J Rzeszutek, PhD, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842588
- Sponsor's protocol ID
- 117103
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
- ClinicalTrials.gov ID
- NCT07842588
- Acronym / sponsor ID
- 117103
- Conditions
- Alcohol Use Disorder (AUD), Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Mark J Rzeszutek, PhDUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 25 Sep 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 evaluate the relationship between alcohol use, suicidal thoughts and behaviors, and behavioral economic decision-making. Participants will complete surveys over approximately 12 weeks and will be randomly assigned to receive access to a self-guide computerized cognitive behavioral therapy (CBT4CBT) program either immediately or after a waiting period. The study will compare participants with and without recent suicidal thoughts and behaviors to better understand factors associated with alcohol use and engagement with treatment.
Detailed description
This randomized, 2x2 factorial study will enroll adults who drink alcohol regularly and are interested in reducing or stopping their alcohol use. Participants will complete four online assessments approximately four weeks apart over a 12 week study period. The assessments include questionnaires about alcohol use, suicidal thoughts and behaviors and behavioral economic decision-making.
Participants will be randomly assigned to receive access to Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT) program either immediately after the baseline assessment or after the second follow-up assessment. The study will compare participants with and without recent suicidal thoughts and behaviors to evaluate differences in decision-making, alcohol use, and engagement with the CBT4CBT program. The results may improve understanding of factors related to alcohol use and suicide risk and help inform future interventions for individuals with alcohol use concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT | Experimental | Behavioral: CBT4CBTParticipants with recent suicidal thoughts or behaviors who receive immediate access to CBT4CBT. |
| Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT | Active comparator | Behavioral: CBT4CBTParticipants with recent suicidal thoughts or behaviors who receive delayed access to CBT4CBT after the second follow-up assessment. |
| No Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT | Experimental | Behavioral: CBT4CBTParticipants without recent suicidal thoughts or behaviors who receive immediate access to CBT4CBT. |
| No Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT | Active comparator | Behavioral: CBT4CBTParticipants without recent suicidal thoughts or behaviors who receive delayed access to CBT4CBT after the second follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consume alcohol at least weekly
- Score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
- Some interest in cutting back on drinking or quitting
- Read and understand English
- Recent active/passion ideation
Key exclusion criteria (4 listed)
- Score of 31 or greater on the AUDIT
- Having unmanaged psychiatric diagnoses
- Already being in treatment for alcohol use disorder at baseline
- Past month substance use other than cannabis or tobacco
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 |
|---|---|---|
| CBT4CBTComputer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), a self-guided computerized cognitive behavioral therapy program for alcohol use. Participants receive access either immediately following the baseline assessment or after the second follow-up assessment. | Behavioural | No Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT, No Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT, Recent Suicidal Thoughts/Behaviors + Delayed CBT4CBT, Recent Suicidal Thoughts/Behaviors + Immediate CBT4CBT |
Primary outcome
Change in Alcohol Use
Time frame: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
Change in alcohol consumption measured using the 28-day Timeline Follow-Back (TLFB).
Change in Suicidal Thoughts and Behaviors
Time frame: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.
Change in suicidal thoughts and behaviors as measured by the Colombia Suicide Severity Rating Scale (C-SSRS)
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 25 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CBT4CBT in people with Alcohol Use Disorder (AUD) and Suicidal Ideation, run by Mark J Rzeszutek, PhD.
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 4 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mark Rzeszutek, PhD (859-323-5264, mark.rzeszutek@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use (time frame: Baseline, 4 Weeks, 8 Weeks, and 12 Weeks.). The study lists 2 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 25 Sep 2026.