Alcohol DependenceNCT02108054
Behavioral and Functional Task Development, Implementation, and Testing
A study testing 7T MRI in people with Alcohol Dependence and Alcohol Drinking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence, Alcohol Drinking, Alcoholism
- What is being tested?
- 7T MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2014to 18 Nov 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies*.
Who cannot join
- Are not cleared on a neuromotor examination
- Are currently receiving psychotropic medication
- Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the
- past 30 days CIWA score > 8).
- -MRI Exclusion Criteria:
- Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;
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- Are pregnant, as determined by a negative pregnancy test
- Left handed
- Claustrophobia.
- To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.
Read more
Objective:
- To develop tasks that investigate a person s behavior that can be used in later studies.
Eligibility:
- Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old.
- Healthy right-handed volunteers 18-65 years old.
Design:
- Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview.
- Participants will have between one and three visits.
- Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder.
- Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it.
- The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.
Read the detailed description
Objective:
The purpose of this protocol is three-fold: 1) to develop tasks examining various cognitive, motivational, and decision-making behaviors outside the scanner; 2) to modify, refine, and verify the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation; and 3) to examine equivalent or surrogate signals using other devices such as electroencephalograph (EEG) and functional near infrared spectrometer (fNIRS) when the MR contraindication(s) are present in the participant.
Study population:
Healthy volunteers without an alcohol use disorder, and inpatient participants with alcohol dependence as determined by the DSM-IV-TR or at least Moderate Alcohol Use Disorder as determined by DSM-5.
Design:
The participants will pilot one or both aspects of this study depending on whether the task is de novo or a modification to previously verified or published task.
Outcome measures:
The outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors and invoke associated brain systems and functions in our targeted subject populations.
- Being tested
- 7T MRI
- Keywords
- fMRI, Alcoholism, Phenotype, Imaging, EEG, Psychophysiology, Near Infrared
- Medical subject headings
- Alcoholism, Alcohol Drinking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7T MRIDevice
Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | People with alcohol use disorder Receives: Device: 7T MRI |
| 2 | Experimental | People without alcohol use disorder Receives: Device: 7T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors
Tasks that are suitable for fMRI studies and other clinical research measurements
Measured: ONGOING
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study start28 May 2014
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Paule V Joseph, C.R.N.P., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108054
- Sponsor's protocol ID
- 140066
- Other IDs
- 14-AA-0066
- Status last verified
- 7 Oct 2026
- First submitted
- 8 Apr 2014
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study is designed to determine and modify tasks to induce and affect various behavioral, psychophysiological and neural responses. Therefore, it appears that in order to make such data available they should be collected in future hypothesis driven studies that utilize the tasks developed under this protocol.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Functional Task Development, Implementation, and Testing
- ClinicalTrials.gov ID
- NCT02108054
- Acronym / sponsor ID
- 140066
- Keywords
- fMRI, Alcoholism, Phenotype, Imaging, EEG, Psychophysiology, Near Infrared
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 28 May 2014 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 9 Apr 2014 (estimated)
- 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.
Background:
- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies.
Objective:
- To develop tasks that investigate a person s behavior that can be used in later studies.
Eligibility:
- Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old.
- Healthy right-handed volunteers 18-65 years old.
Design:
- Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview.
- Participants will have between one and three visits.
- Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder.
- Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it.
- The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.
Detailed description
Objective:
The purpose of this protocol is three-fold: 1) to develop tasks examining various cognitive, motivational, and decision-making behaviors outside the scanner; 2) to modify, refine, and verify the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation; and 3) to examine equivalent or surrogate signals using other devices such as electroencephalograph (EEG) and functional near infrared spectrometer (fNIRS) when the MR contraindication(s) are present in the participant.
Study population:
Healthy volunteers without an alcohol use disorder, and inpatient participants with alcohol dependence as determined by the DSM-IV-TR or at least Moderate Alcohol Use Disorder as determined by DSM-5.
Design:
The participants will pilot one or both aspects of this study depending on whether the task is de novo or a modification to previously verified or published task.
Outcome measures:
The outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors and invoke associated brain systems and functions in our targeted subject populations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: 7T MRIPeople with alcohol use disorder |
| 2 | Experimental | Device: 7T MRIPeople without alcohol use disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies*.
Key exclusion criteria (10 listed)
- Are not cleared on a neuromotor examination
- Are currently receiving psychotropic medication
- Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the
- past 30 days CIWA score > 8).
- Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;
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 |
|---|---|---|
| 7T MRIModifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation | Device | 1, 2 |
Primary outcome
outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors
Time frame: ONGOING
Tasks that are suitable for fMRI studies and other clinical research measurements
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 9 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This study is designed to determine and modify tasks to induce and affect various behavioral, psychophysiological and neural responses. Therefore, it appears that in order to make such data available they should be collected in future hypothesis driven studies that utilize the tasks developed under this protocol.
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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.
Paule V Joseph, C.R.N.P. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7T MRI in people with Alcohol Dependence and Alcohol Drinking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 1 inclusion and 10 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 9 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?
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?
outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors (time frame: ONGOING). 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 9 Oct 2026.