Neurobiological Responses in Alcoholism and Early Trauma

Alcohol Use Disorder Clinical Trial

Official title:

Neurobiological Responses in Alcoholism and Early Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04128228
• Other study ID #: 2000024809
• Secondary ID: 1R01AA026844
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Est. completion date: September 8, 2023

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alcohol use disorder with early trauma is associated with clinical challenges, including high comorbid symptoms and relapse rates. To better understand this phenomenon, this study will examine the neurobiological mechanisms underlying the relationship between alcohol use disorder, early trauma, and the high relapse risk. The current study utilizes a multimodal neuroimaging technique combining brain and hypothalamic-pituitary-adrenal axis (HPA) measures within a prospective clinical outcome design.

Description:

The current study intends to recruit four groups matched in demographic characteristics (age, sex ratio, education years). These groups include individuals with alcohol use disorder (AUD) with and without a history of early trauma, as well as healthy controls with and without a history of early trauma. The study procedures involve functional magnetic resonance imaging (fMRI) scan(s), eight weeks of outpatient treatment, and a follow-up phase. During the fMRI session, all participants will engage in a well-validated sustained emotion provocation task, involving the viewing of stress, alcohol-cue, and neutral pictures, while concurrent collection of brain and stress hormone data takes place. Control participants will undergo a single fMRI session at baseline, whereas AUD participants will partake in two fMRI sessions before and after outpatient treatment. Following the scan(s), a prospective follow-up will be conducted to monitor stress, alcohol, and health-related behaviors, which involves face-to-face interviews at 14, 30, 90 days, alongside daily monitoring using a smartphone app. Control participants will be followed for 30 days, while AUD participants will be followed for 90 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: September 8, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Early Trauma Complications
• Wounds and Injuries

Intervention

Behavioral:
• 8-week outpatient treatment
Individuals with alcohol use disorder will receive an 8-week outpatient treatment, involving two sessions per week that integrate cognitive behavioral therapy with breathing-based stress management.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic neural response	Brain response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task using functional magnetic resonance imaging.	baseline, after treatment (up to 8 weeks)
Primary	Stress hormone response	Cortisol response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task.	baseline, after treatment (up to 8 weeks)
Primary	Alcohol relapse	Time to relapse (event based); the first day of drink during the follow-up period.	up to 90 days
Secondary	Alcohol use (frequency)	The total number of days of alcohol use during the follow-up period.	up to 90 days
Secondary	Alcohol use (quantity)	The average amount of alcohol use per day during the follow-up period.	up to 90 days