Clinical trial NCT04128228: Neurobiological Responses in Alcoholism and Early Trauma
Official title: Neurobiological Responses in Alcoholism and Early Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Early Trauma Complications
Keywords: Alcohol use disorder
Early trauma
fMRI
Stress hormone
Alcohol relapse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-10-16
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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)

Primary outcomes:
measure: Brain Response
timeFrame: baseline
measure: Stress Hormone Response (Cortisol to ACTH Ratio)
timeFrame: baseline
measure: Time to Relapse
timeFrame: up to 90 days
Secondary outcomes:
measure: Amount of Alcohol Consumption (Weekly)
timeFrame: up to 90 days
measure: Frequency of Alcohol Use (Percentage)
timeFrame: up to 90 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Dongju Seo, PhD
role: PRINCIPAL_INVESTIGATOR
References: