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NCT03535129 · ClinicalTrials.gov registry record · NA
A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
A NA study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
NCT03535129: Completed NA study, sponsored by National Institutes of Health Clinical Center (CC).
NCT03535129 is a NA study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 101 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03535129, a NA study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
Study Summary
Background: Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person's social behavior and brain structure, but researchers don't have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem drinking. Objectives: * To study what happens in the brains of people who drink alcohol when they look at pictures of social things and of alcohol. * To learn if people can control brain activity in a magnetic resonance imaging (MRI) scanner and if this helps people with drinking. Eligibility: * Adults ages 21 to 65 who have an alcohol use disorder. * Healthy volunteers ages 21 to 65 Design: Participants will be screened with * Physical exam * Medical history * Blood, urine, and heart tests * Mental health interview * Questions about their alcohol drinking. At each session, participants will have: * A urine test for drugs and pregnancy. If they test positive, they cannot participate. * A breath alcohol test and assessment for alcohol withdrawal. Participants will complete surveys, talk to researchers about behaviors, and play games. Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic field. They will lie on a table that slides in and out of the scanner for 1-2 hours. Participants will do tasks in the scanner: * They will look at pictures, sometimes of alcohol. * They will try to hit a goal. Some participants will get feedback during this task. They will see how their brain activity changes or how someone else's changes. Participants may have follow-up phone questions at least 3 times over about 6 months.
Primary Outcome
Contrast in the estimated blood-oxygen-level-dependent (BOLD) response between the conditions of # 1) negative socioemotional cue paired with an alcohol cue, and #2) negative Socioemotional cue paired with a neutral cue during the fMRI brain scan. The contrast value was calculated by subtracting the BOLD response value for condition #1 from the BOLD response value from condition #2.
Interventions
- BEHAVIORAL Real time fMRI neurofeedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2025-03-23 |
| Phase | NA |
What the finished NCT03535129 record still lists
NCT03535129 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Real time fMRI neurofeedback is the first listed.
NCT03535129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03535129 about?
NCT03535129 is a clinical study titled "A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder". Background: Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a person's social behavior and brain structure, but researchers don't have a good understanding of how. They want to test a technique called neurofeedback to learn more about how to treat problem...
What is the current status of trial NCT03535129?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2018-09-20. Estimated completion is 2025-03-23.
What interventions are being tested in trial NCT03535129?
The interventions under investigation include: Real time fMRI neurofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03535129?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03535129's enrollment target sits among peer trials
101 840th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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