Neurobiological Responses in Alcoholism and Early Trauma

NCT04128228 | Completed Results

• 2 other identifiers: 20000248091R01AA026844
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Early Trauma Complications

Keywords

Alcohol use disorder; Early trauma; fMRI; Stress hormone; Alcohol relapse

Outcome Measures

Primary Outcomes (3)

• Brain Response

  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 to which a specific condition contributes to changes in the BOLD (Blood Oxygen Level Dependent) signal in a particular brain region. A positive beta in the vmPFC would indicate an increased vmPFC response, whereas a negative beta would indicate a decreased vmPFC response compared to baseline. The magnitude of the beta reflects the strength of this effect: a larger absolute value, (whether positive or negative), suggests a greater change in brain activation in response to the condition.

  baseline

• Stress Hormone Response (Cortisol to ACTH Ratio)

  Cortisol to Adrenocorticotropic Hormone (ACTH) ratio indicates the relationship between cortisol secretion and ACTH stimulation at baseline. Cortisol is measured in micrograms per deciliter (µg/dL) and ACTH (adrenocorticotropic hormone) is measured in picograms per milliliter (pg/mL). Therefore, the unit of cortisol to ACTH ratio is expressed in µg/dL per pg/mL. Stress hormone samples were collected during the MRI scan.

  baseline

• Time to Relapse

  The first day of alcohol consumption after treatment during the 90-day follow-up period. Alcohol use data was measured using the Timeline Follow-Back (TLFB) method, a calendar-based self-report tool to track alcohol use. Participants recalled their drinking behavior using a calendar and reported both the days they consumed alcohol and the number of drinks consumed on each of those days. Alcohol use data during the 90-day follow-up period is available only for the AUD/ET and AUD/NT groups, as the MD/ET and MD/NT groups had not initiated treatment.

  up to 90 days

Secondary Outcomes (2)

• Amount of Alcohol Consumption (Weekly)

  up to 90 days

• Frequency of Alcohol Use (Percentage)

  up to 90 days

Study Arms (4)

Alcohol use disorder with early trauma

OTHER

Individuals with alcohol use disorder participated in an equivalent 8-week outpatient treatment program.

Behavioral: 8-week outpatient treatment

Alcohol use disorder without early trauma

OTHER

Individuals with alcohol use disorder participated in an equivalent 8-week outpatient treatment program.

Behavioral: 8-week outpatient treatment

Controls with early trauma

NO INTERVENTION

Control participants did not receive any treatment.

Controls without early trauma

NO INTERVENTION

Control participants did not receive any treatment.

Interventions

8-week outpatient treatment BEHAVIORAL

Individuals with AUD participated in an 8-week treatment program integrating cognitive behavioral techniques focused on emotion regulation with breathing-based stress management.

Alcohol use disorder with early trauma; Alcohol use disorder without early trauma

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Alcohol use disorder
• Either low or high early trauma (based on the Childhood Trauma Questionnaire)
• Body mass index (BMI) up to 35 (due to weight limitations of the MRI scanner)

You may not qualify if:

• Current or past substance use disorder other than alcohol; excluding caffeine and nicotine
• Psychiatric disorders except for mood and anxiety disorders
• Any significant current medical conditions
• Women who are peri- and post- menopausal, pregnant or lactating

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06492, United States

Location

MeSH Terms

Conditions

Alcoholism; Wounds and Injuries

Interventions

Ambulatory Care

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dongju Seo
• Organization: Department of Psychiatry, Yale University School of Medicine

dongju.seo@yale.edu

475-441-3457

Study Officials

• Dongju Seo, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following baseline assessments including multimodal neuroimaging, AUD individuals with and without a history of early trauma received an equivalent 8-week outpatient treatment. Control participants with and without early trauma did not receive any treatment after baseline assessments.

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: October 3, 2019
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-10

Locations

US (1)