Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04128228 · ClinicalTrials.gov registry record · NA

Neurobiological Responses in Alcoholism and Early Trauma

A NA study, sponsored by Yale University.

Completed
Registry status
NA
Development phase
148
Enrollment target

NCT04128228 is a NA study that has completed, run by Yale University. The registered enrollment target is 148 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04128228, a NA study, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
148 participants
Enrollment target

Study Summary

Alcohol use disorder (AUD) accompanied by early trauma presents clinical challenges, including elevated rates of comorbid emotional symptoms and relapse. To better understand this co-occurring condition, this study investigates the neurobiological responses associated with AUD and early trauma. Using a multimodal neuroimaging approach, including functional magnetic resonance imaging (fMRI), the study concurrently measures brain activity and stress hormone responses in individuals with AUD and control participants, both with and without early trauma. The primary goal is to examine neurobiological responses and relapse patterns following treatment in individuals with AUD, with and without a history of early trauma. Conventional alcohol treatments often fail to specifically address the emotional complications in AUD individuals with early trauma. Therefore, this study also explores whether incorporating stress regulation into alcohol relapse prevention can improve outcomes for this population. Following baseline assessments that included multimodal neuroimaging, all participants with AUD received an 8-week outpatient treatment program integrating cognitive-behavioral methods focused on emotion regulation with stress reduction techniques, particularly self-regulated breathing strategies.

Interventions

  • BEHAVIORAL 8-week outpatient treatment

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2019-10-03
Est. Completion 2023-09-08
Phase NA

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT04128228

The ClinicalTrials.gov registry entry for NCT04128228 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 8-week outpatient treatment is the first listed.

NCT04128228 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04128228 about?

NCT04128228 is a clinical study titled "Neurobiological Responses in Alcoholism and Early Trauma". Alcohol use disorder (AUD) accompanied by early trauma presents clinical challenges, including elevated rates of comorbid emotional symptoms and relapse. To better understand this co-occurring condition, this study investigates the neurobiological responses associated with AUD and early trauma. Usin...

What is the current status of trial NCT04128228?

This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2019-10-03. Estimated completion is 2023-09-08.

What interventions are being tested in trial NCT04128228?

The interventions under investigation include: 8-week outpatient treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT04128228?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.