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: Completed NA study, sponsored by Yale University.

NCT04128228 is a NA study that has completed, run by Yale University. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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.

Primary Outcome

Brain responses during the viewing of stress, alcohol-cue, and neutral images were examined using functional magnetic resonance imaging (fMRI) during an emotion provocation task. A regions of interest (ROI) analysis was conducted to assess brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas, and beta values were obtained using the BioImage Suite. The beta coefficient represents the extent

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
Yale University

1,492 total trials

What the finished NCT04128228 record still lists

NCT04128228 is an interventional study that assigns participants to a tested intervention. The registered 148 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 (89% lower).

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

NCT04128228 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04128228's enrollment target sits among peer trials

148 702nd of 2000 higher than 1,298 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00739362 · 148 participants · Phase 2

    Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

  • NCT03161223 · 148 participants · Phase 1

    Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

  • NCT03858231 · 148 participants · Phase 4

    Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

  • NCT04486352 · 148 participants · Phase 1

    A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT04128228, the US trial registry maintained by the National Library of Medicine. NCT04128228 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.