Neurobiological Responses in Alcoholism and Early Trauma

NCT ID: NCT04128228

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-03
• Study Completion Date: 2023-09-08

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.

Detailed Description

The study recruited four demographically matched groups (age, sex ratio): individuals with AUD with and without a history of early trauma, and moderate drinkers with and without early trauma. Study procedures involved functional magnetic resonance imaging (fMRI), an eight-week outpatient treatment program, and a 90-day follow-up period. During fMRI sessions, participants engaged in a validated emotion provocation task, viewing stress, alcohol-cue, and neutral images while concurrent brain and stress hormone data are collected. Individuals with AUD completed baseline assessments, including multimodal neuroimaging, and then participated in an 8-week treatment program consisting of two sessions per week. This program integrated cognitive-behavioral techniques focused on emotion regulation with breathing-based stress management. Control participants completed baseline assessments including multimodal neuroimaging but did not receive any treatment. Following the treatment, participants with AUD were prospectively followed for 90 days, with remote follow-up interviews conducted at 14, 30, 90 days via video communication.

Conditions

Alcohol Use Disorder; Early Trauma Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Alcohol use disorder with early trauma

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

Group Type: OTHER

8-week outpatient treatment

Intervention Type: 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 without early trauma

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

Group Type: OTHER

8-week outpatient treatment

Intervention Type: BEHAVIORAL

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

Controls with early trauma

Control participants did not receive any treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Controls without early trauma

Control participants did not receive any treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

8-week outpatient treatment

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongju Seo, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1R01AA026844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000024809

Identifier Type: -

Identifier Source: org_study_id