Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alcohol Drinking Related Problems
  • Alcohol Related Disorders
  • Healthy Volunteers
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Care Provider)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 65 years
Gender
Both males and females

Description

Objective The purpose of this protocol is to understand the mechanism whereby neural processes of socioemotional cognition associated with alcohol use disorders lead to negative drinking consequences. This study is a two-stage procedure to both provide evidence of a response modulation deficit assoc...

Objective The purpose of this protocol is to understand the mechanism whereby neural processes of socioemotional cognition associated with alcohol use disorders lead to negative drinking consequences. This study is a two-stage procedure to both provide evidence of a response modulation deficit associated with socioemotioal processing in individuals with alcohol use disorder and investigate how moderating that deficit affects socioemotional processing and negative drinking consequences. Study Population Community participants both with and without alcohol use disorder and Inpatients with alcohol use disorder. Design In the first stage, participants will undergo functional magnetic resonance imaging while looking at socioemotional stimuli and alcohol cues and will pilot a neurofeedback training protocol. Personality traits and executive function will also be investigated. In the second stage, inpatient participants with alcohol use disorder will be randomly assigned to receive active or sham neurofeedback. Participants will undergo two functional magnetic resonance imaging sessions including looking at socioemotional stimuli and alcohol cues, resting state fMRI, and real time neurofeedback during alcohol craving. Ability to inhibit attention to alcohol cues and craving will be assessed prior to and following the neurofeedback as well. Participants will be contacted approximately 1 month, 3 months, and 6 months post release from inpatient treatment to assess outcomes. Outcome The primary outcome of this study is to demonstrate that deficits in response modulation in the presence of alcohol cues drive socioemotional processing and negative drinking outcomes. The mechanism will be demonstrated through less socioemotional neural processing in alcohol cued compared to non-alcohol cued conditions, and through evidence that down regulation of alcohol cue salience reduces the alcohol cue effect on socioemotional processing.

Tracking Information

NCT #
NCT03535129
Collaborators
Not Provided
Investigators
Principal Investigator: Reza Momenan, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)