ClinicalTrials.gg
Sign In
CompletedNCT02108054Updated Oct 9, 2026

Behavioral and Functional Task Development, Implementation, and Testing

An interventional study of 7T MRI in Alcohol Dependence, Alcohol Drinking and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Not applicable, Interventional, and Other

Updated Oct 9, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Alcohol Dependence
  • Alcohol Drinking
  • Alcoholism
  • Alcohol Use Disorder
  • Addiction

Keywords

  • fMRI
  • Alcoholism
  • Phenotype
  • Imaging
  • EEG
  • Psychophysiology
  • Near Infrared
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's enrollment of 173 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 102 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.

Browse National Institute on Alcohol Abuse and Alcoholism (NIAAA) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • between 18-65 years of age. The PI or designated AI will determine if any of the exclusion criteria listed below applies*.

Exclusion criteria

EXCLUSION CRITERIA:

  • 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;
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
173 participants (actual)

Study arms

  • Experimental
    1

    People with alcohol use disorder

    Device: 7T MRI

  • Experimental
    2

    People without alcohol use disorder

    Device: 7T MRI

Interventions

  • Device7T MRI

    Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: ONGOING

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2014 to primary completion in Nov 2025, 137 months.

Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's 137 months is above that.

Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: primary completion Dec 2026 → Nov 2025 and completion Dec 2026 → Nov 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 8, 2014
First posted
Apr 9, 2014
StartActual
May 28, 2014
Primary completionActual
Nov 18, 2025was Dec 2026
CompletionActual
Nov 18, 2025was Dec 2026
Last update
Oct 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 9, 2026
Primary completion
Dec 31, 2026→Nov 18, 2025 (actual)
Oct 9, 2026
Study completion
Dec 31, 2026→Nov 18, 2025 (actual)
Oct 9, 2026
Enrollment
400 (estimated)→173 (actual)
Oct 9, 2026
Eligibility
Revised
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    Recruiting→Completed
    Primary completion Dec 31, 2026→Nov 18, 2025 (now actual)
    Study completion Dec 31, 2026→Nov 18, 2025 (now actual)
    Enrollment 400 (estimated)→173 (actual)
    Eligibility Revised
    + 4 other changes: verification date, contact details, site details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02108054
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Apr 9, 2014
Start date
May 28, 2014
Primary completion
Nov 18, 2025
Completion
Nov 18, 2025
Last update
Oct 9, 2026

Study contacts

Paule V Joseph, C.R.N.P.
principal investigator · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Alcoholism →

Other studies from this sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) →

Start the discussion