Neurobiological Responses in Alcoholism and Early Trauma

Yale University

Status: Completed

Conditions: Early Trauma Complications; Alcohol Use Disorder

Treatments: Behavioral: 8-week outpatient treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04128228

1R01AA026844 (U.S. NIH Grant/Contract)

2000024809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

AUD 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)

AUD 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
• MRI specific exclusion criteria (e.g., claustrophobia, implanted metal in the body)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

148 participants in 4 patient groups

Alcohol use disorder with early trauma

Other group

Description:

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

Treatment:

Behavioral: 8-week outpatient treatment

Alcohol use disorder without early trauma

Other group

Description:

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

Treatment:

Behavioral: 8-week outpatient treatment

Controls with early trauma

No Intervention group

Description:

Control participants did not receive any treatment.

Controls without early trauma

No Intervention group

Description:

Control participants did not receive any treatment.