Alcohol DrinkingNCT04895033
Brain Responses to Contextual Influences on Drinking Decisions
A study testing Responsibility condition in people with Alcohol Drinking, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Responsibility condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Jul 2025
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-55 years of age;
- current heavy alcohol drinking in the past three months, as indicated by reporting consumption of 14 or more drinks per week for men or 7 or more drinks per week for women and at least one heavy drinking episode weekly (5+/4+ drinks in a single occasion for males/females);
- belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities;
- speak English;
- normal or corrected to normal vision and hearing;
- able to give informed consent.
Who cannot join
- currently engaged in treatment or seeking treatment for alcohol-related problems;
- major psychiatric illness (psychotic disorder, bipolar disorder, post-traumatic stress disorder);
- Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine);
- attending any in-person session with a positive breath alcohol concentration (BrAC > 0.00%);
- any contraindications for MRI scanning (e.g., metal in body surgically or accidentally including pacemaker, cochlear implants, aneurysm clips, shrapnel, etc.);
- history of seizures or anti-seizure medication;
- history of concussion or other significant brain injury;
- serious medical illness unsuitable for the MRI scanner based on best clinical judgment
Trial locations and contacts
1 site in 1 country.
United States1 site
Cofrin Logan Center for Addiction Research and Treatment
Lawrence, Kansas, 66045
About this study
This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks.
Read the detailed description
The overall objective of this study is to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks. The study involves two testing sessions -- a baseline interview conducted virtually or in-person, and a MRI scanning session at University of Kansas Medical Center. Participants (N=80, 50% female, age 21-55) are community adults who report drinking alcohol in excess of NIAAA-recommended weekly drinking limits (i.e., heavy drinkers who consume 14/7+ drinks per week for men/women). Participants will complete hypothetical alcohol purchase tasks during the MRI scan with two conditions being examined. A control condition involves a typical drinking situation with no explicit responsibilities. An experimental condition involves a hypothetical situation with important personally-relevant responsibilities the next day (e.g., a presentation at work, an exam, or caregiving responsibilities).
- Conditions
- Alcohol Drinking
- Being tested
- Responsibility condition
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Responsibility conditionBehavioural
During the fMRI scan, participants will complete alcohol purchase task paradigm for hypothetical alcohol rewards under two conditions. In the next-day responsibility condition, we will present a vignette describing a drinking scenario in which participants have a significant activity the next day (e.g., a work, family, or academic obligation the next morning) and participants are asked to imagine they are deciding how much they want to drink in this situation. The control condition will use a vignette describing a typical drinking scenario with no explicit responsibilities the next day
| Study group | Role | What they receive |
|---|---|---|
| Responsibility vs No Responsibility | Experimental | Within-subjects experimental manipulation of responsibility vs. no-responsibility condition Receives: Behavioral: Responsibility condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol demand
Participants will report how many standard drinks they would consume at varying prices using a hypothetical Alcohol Purchase Task (APT) procedure. The APT is a validated self-report measure of alcohol consumption (in standard drink units) at escalating prices (18 price intervals, ranging from $0 to $80/drink). Responses on APT are analyzed to generate observed and derived indices of alcohol demand, including: intensity (consumption at free price); breakpoint (maximum price for spent for a single drink); Omax (maximum expenditure on alcohol); and Elasticity (proportionate slope of the alcohol demand curve)
Measured: During 1 hour MRI scan
Brain activation
Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging
Measured: During 1 hour MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Feb 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study uses a within-subjects design with all participants completing the no-responsibility and responsibility conditions.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Sponsor
- Investigators
- Michael Amlung, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895033
- Sponsor's protocol ID
- STUDY00147117
- Status last verified
- Nov 2025
- First submitted
- 12 May 2021
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is complete, the researchers are encouraged by NIH funding guidelines to deposit de-identified fMRI data and associated baseline data into a public access archive such as NeuroVault, a secure repository where researchers can publicly store and share unthresholded statistical maps, parcellations, and atlases produced by fMRI studies. The investigators will take all necessary steps to ensure that only de-identified data is made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Responses to Contextual Influences on Drinking Decisions
- ClinicalTrials.gov ID
- NCT04895033
- Acronym / sponsor ID
- STUDY00147117
- Conditions
- Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 20 May 2021 (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 is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks.
Detailed description
The overall objective of this study is to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks. The study involves two testing sessions -- a baseline interview conducted virtually or in-person, and a MRI scanning session at University of Kansas Medical Center. Participants (N=80, 50% female, age 21-55) are community adults who report drinking alcohol in excess of NIAAA-recommended weekly drinking limits (i.e., heavy drinkers who consume 14/7+ drinks per week for men/women). Participants will complete hypothetical alcohol purchase tasks during the MRI scan with two conditions being examined. A control condition involves a typical drinking situation with no explicit responsibilities. An experimental condition involves a hypothetical situation with important personally-relevant responsibilities the next day (e.g., a presentation at work, an exam, or caregiving responsibilities).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study uses a within-subjects design with all participants completing the no-responsibility and responsibility conditions.
| Arm | Type | Receives |
|---|---|---|
| Responsibility vs No Responsibility | Experimental | Behavioral: Responsibility conditionWithin-subjects experimental manipulation of responsibility vs. no-responsibility condition |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 21-55 years of age;
- current heavy alcohol drinking in the past three months, as indicated by reporting consumption of 14 or more drinks per week for men or 7 or more drinks per week for women and at least one heavy drinking episode weekly (5+/4+ drinks in a single occasion for males/females);
- belong to a category with significant responsibilities, such as being currently employed, a current student, or a caregiver with significant responsibilities;
- speak English;
- normal or corrected to normal vision and hearing;
Key exclusion criteria (8 listed)
- currently engaged in treatment or seeking treatment for alcohol-related problems;
- major psychiatric illness (psychotic disorder, bipolar disorder, post-traumatic stress disorder);
- Diagnostic and Statistical Manual Version-5 substance use disorder (except nicotine);
- attending any in-person session with a positive breath alcohol concentration (BrAC > 0.00%);
- any contraindications for MRI scanning (e.g., metal in body surgically or accidentally including pacemaker, cochlear implants, aneurysm clips, shrapnel, etc.);
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 |
|---|---|---|
| Responsibility conditionDuring the fMRI scan, participants will complete alcohol purchase task paradigm for hypothetical alcohol rewards under two conditions. In the next-day responsibility condition, we will present a vignette describing a drinking scenario in which participants have a significant activity the next day (e.g., a work, family, or academic obligation the next morning) and participants are asked to imagine they are deciding how much they want to drink in this situation. The control condition will use a vignette describing a typical drinking scenario with no explicit responsibilities the next day | Behavioural | Responsibility vs No Responsibility |
Primary outcome
Alcohol demand
Time frame: During 1 hour MRI scan
Participants will report how many standard drinks they would consume at varying prices using a hypothetical Alcohol Purchase Task (APT) procedure. The APT is a validated self-report measure of alcohol consumption (in standard drink units) at escalating prices (18 price intervals, ranging from $0 to $80/drink). Responses on APT are analyzed to generate observed and derived indices of alcohol demand, including: intensity (consumption at free price); breakpoint (maximum price for spent for a single drink); Omax (maximum expenditure on alcohol); and Elasticity (proportionate slope of the alcohol demand curve)
Brain activation
Time frame: During 1 hour MRI scan
Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging
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 14 Nov 2025.
- Individual participant dataSharing planned: Yes. After the study is complete, the researchers are encouraged by NIH funding guidelines to deposit de-identified fMRI data and associated baseline data into a public access archive such as NeuroVault, a secure repository where researchers can publicly store and share unthresholded statistical maps, parcellations, and atlases produced by fMRI studies. The investigators will take all necessary steps to ensure that only de-identified data is made publicly available.
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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.
Michael Amlung, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Responsibility condition in people with Alcohol Drinking, run by University of Kansas Medical Center 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 6 inclusion and 8 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 14 Nov 2025. 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?
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 demand (time frame: During 1 hour MRI scan). 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 14 Nov 2025.