Neurobiological Responses in Alcoholism and Early Trauma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alcohol Use Disorder
- Early Trauma Complications
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: All patents will receive the same 8-week outpatient treatment and the effects of intervention will be assessed before and after the treatment.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 21 years and 50 years
- Gender
- Both males and females
Description
The current study will recruit four demographically-matched groups (total N=160; N=40 each; equal gender) including alcohol use disorder (AUD) patients with and without early trauma, and healthy controls with and without early trauma. General study procedures include functional magnetic resonance im...
The current study will recruit four demographically-matched groups (total N=160; N=40 each; equal gender) including alcohol use disorder (AUD) patients with and without early trauma, and healthy controls with and without early trauma. General study procedures include functional magnetic resonance imaging (fMRI) scan(s), eight weeks of outpatient treatment, and a follow-up phase. During the fMRI session, participants will engage in a task involving the viewing of stress, alcohol, neutral pictures using a well-validated sustained emotion provocation task, while their brain and stress hormone data are concurrently collected. Controls will participate in a single fMRI session at baseline, and AUD patients will participate in two fMRI sessions before and after outpatient treatment. Subsequently after the scan(s), all participants will be prospectively followed for daily monitoring of stress, alcohol, and health related behaviors using a smartphone app. Controls will be followed for 30 days. AUD patients will be followed for 90 days, which includes face-to-face interviews at 14, 30, 90 days in addition to daily monitoring using a mobile app.
Tracking Information
- NCT #
- NCT04128228
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Principal Investigator: Dongju Seo, PhD Yale University