A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
Background:

 Problem drinking affects nearly half the people who drink alcohol. Drinking alcohol affects a
 person s social behavior and brain structure, but researchers don t have a good understanding
 of how. They want to test a technique called neurofeedback to learn more about how to treat
 problem drinking.

 Objectives:

 To study what happens in the brains of people who drink alcohol when they look at pictures of
 social things and of alcohol. To learn if people can control brain activity in a magnetic
 resonance imaging (MRI) scanner and if this helps people with drinking.

 Eligibility:

 Adults ages 21 65 who have an alcohol use disorder.

 Healthy volunteers ages 21 65

 Design:

 Participants will be screened with

 Physical exam

 Medical history

 Blood, urine, and heart tests

 Mental health interview

 Questions about their alcohol drinking.

 At each session, participants will have:

 A urine test for drugs and pregnancy. If they test positive, they cannot participate.

 A breath alcohol test and assessment for alcohol withdrawal.

 Participants will complete surveys, talk to researchers about behaviors, and play games.

 Participants will have MRI brain scans. The scanner is a metal cylinder in a strong magnetic
 field. They will lie on a table that slides in and out of the scanner for 1 2 hours.

 Participants will do tasks in the scanner:

 They will look at pictures, sometimes of alcohol.

 They will try to hit a goal. Some participants will get feedback during this task. They will
 see how their brain activity changes or how someone else s changes.

 Participants may have follow-up phone questions at least 3 times over about 6 months.
1. 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.

 2. Study Population

 Community participants both with and without alcohol use disorder and Inpatients with
 alcohol use disorder.

 3. 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.

 4. 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.
-  INCLUSION CRITERIA:

 Stage 1:

 INCLUSION CRITERIA:

 1. 21 to 65 years old

 2. Healthy volunteers only: Consuming on average 7 or less standard drinks/week if
 female; 14 or less standard drinks/week if male (as determined by the most recent
 measurement within the past 90 days Alcohol Timeline Followback)

 3. AUD participants only: Diagnosed with current moderate to severe alcohol use disorder
 according to most recent SCID 5 diagnosis

 EXCLUSION CRITERIA:

 1. Significant history of head trauma or cranial surgery

 2. History of neurological disease based on self-report and neuromotor physical exam,
 conducted by a health care provider, that would interfere with neuroimaging research.
 Posthoc, clinical MRI scans done according to NIH Clinical Center policy may be
 reviewed and if there is evidence from that scan of past or current neuroabnormalities
 that, in the PI or MAI s expert opinion, interfere with research neuroimaging data,
 the subject may be excluded from data analysis.

 3. Physical health concern that would significantly impair or increase the risk of study
 participation.

 4. Healthy volunteers only: Have fulfilled DSM-5 criteria for a current substance or
 alcohol use disorder

 5. Female participants only: Currently pregnant

 6. Presence of any ferromagnetic objects in the body that may be aversively affected by
 or contraindicated for MRI as determined by the NIAAA MRI Safety Screening
 Questionnaire of the screening protocol 14-AA-0181

 7. Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically
 responsible staff (MD/NP)

 8. History of non-substance related psychosis

 9. Lack of experience with alcohol (defined as less than 3 lifetime drinks

 Stage 2:

 INCLUSION CRITERIA:

 1. 21 to 65 years old

 2. Inpatient currently seeking treatment for alcohol use disorder

 EXCLUSION CRITERIA:

 1. Significant history of head trauma or cranial surgery,

 2. History of neurological disease based on self-report and neuromotor physical exam,
 conducted by a health care provider, that would interfere with neuroimaging research.

 3. Physical health concern that would significantly impair or increase the risk of study
 participation.

 4. Presence of any contraindication for fMRI as determined by the NIAAA MRI Safety
 Screening Questionnaire of the screening protocol 14-AA-0181

 5. Any flag on the NIAAA MRI Safety Screening Questionnaire, unless

 6. History of non-substance related psychosis

 7. Female participants only: Currently pregnant