A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/3/2019 |
| Start Date: | September 20, 2018 |
| End Date: | February 28, 2023 |
| Contact: | Samantha J Fede |
| Email: | samantha.fede@nih.gov |
| Phone: | (301) 594-7416 |
Investigating 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.
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.
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. Physically healthy
3. 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)
4. 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. Healthy volunteers only: Have fulfilled DSM-5 criteria for a current substance or
alcohol use disorder
4. Female participants only: Currently pregnant
5. Presence of any contraindication for fMRI as determined by the NIAAA MRI Safety
Screening Questionnaire of the screening protocol 14-AA-0181
6. History of non-substance related psychosis
7. Lack of experience with alcohol (defined as less than 3 lifetime drinks reported in
history and physical or on Lifetime Drinking History)
Stage 2:
INCLUSION CRITERIA:
1. 21 to 65 years old
2. Physically healthy
3. 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. Presence of any contraindication for fMRI as determined by the NIAAA MRI Safety
Screening Questionnaire of the screening protocol 14-AA-0181
4. History of non-substance related psychosis
5. Female participants only: Currently pregnant
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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