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Neurobiological Responses in Alcoholism and Early Trauma

Primary Purpose

Alcohol Use Disorder, Early Trauma Complications

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8-week outpatient treatment
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder focused on measuring Alcohol use disorder, Early trauma, fMRI, Stress hormone, Alcohol relapse

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Alcohol use disorder

Controls

Arm Description

All patients with alcohol use disorder will receive the same 8 week outpatient treatment.

Control participants with and without early trauma will receive baseline assessment and no outpatient treatment.

Outcomes

Primary Outcome Measures

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.
Stress hormone response
Cortisol response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task.
Alcohol relapse
Time to relapse (event based); the first day of drink during the follow-up period.

Secondary Outcome Measures

Alcohol use (frequency)
The total number of days of alcohol use during the follow-up period.
Alcohol use (quantity)
The average amount of alcohol use per day during the follow-up period.

Full Information

First Posted
October 14, 2019
Last Updated
May 19, 2023
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04128228
Brief Title
Neurobiological Responses in Alcoholism and Early Trauma
Official Title
Neurobiological Responses in Alcoholism and Early Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Early trauma is associated with clinical challenges in treatment alcoholism, including complex clinical symptoms and higher relapse rates. To better understand this phenomena, this study will examine the neurobiological mechanisms underlying alcoholism, early trauma, and high relapse risk. The current study utilizes a multimodal neuroimaging technique combining brain and hypothalamic-pituitary-adrenal axis (HPA) measures in a prospective clinical outcome design.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Early Trauma Complications
Keywords
Alcohol use disorder, Early trauma, fMRI, Stress hormone, Alcohol relapse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol use disorder
Arm Type
Other
Arm Description
All patients with alcohol use disorder will receive the same 8 week outpatient treatment.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Control participants with and without early trauma will receive baseline assessment and no outpatient treatment.
Intervention Type
Behavioral
Intervention Name(s)
8-week outpatient treatment
Intervention Description
All patients will receive outpatient treatment for alcohol use disorder for 8 weeks. There will be two appointments each week for individual therapy sessions using cognitive behavioral therapy combined with stress management.
Primary Outcome Measure Information:
Title
Dynamic neural response
Description
Brain response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task using functional magnetic resonance imaging.
Time Frame
baseline, after treatment (up to 8 weeks)
Title
Stress hormone response
Description
Cortisol response during the viewing of stress and alcohol-cue pictures in a sustained emotion provocation task.
Time Frame
baseline, after treatment (up to 8 weeks)
Title
Alcohol relapse
Description
Time to relapse (event based); the first day of drink during the follow-up period.
Time Frame
up to 90 days
Secondary Outcome Measure Information:
Title
Alcohol use (frequency)
Description
The total number of days of alcohol use during the follow-up period.
Time Frame
up to 90 days
Title
Alcohol use (quantity)
Description
The average amount of alcohol use per day during the follow-up period.
Time Frame
up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongju Seo
Phone
203-737-3361
Email
dongju.seo@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongju Seo, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Neurobiological Responses in Alcoholism and Early Trauma

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