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

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT03535129

Collaborator

(none)

116

Enrollment

Location

Arms

58.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Alcohol Drinking Related Problems Alcohol-Related Disorders	Behavioral: Real time fMRI neurofeedback	N/A

Detailed 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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Investigating a Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder

Actual Study Start Date :

Sep 20, 2018

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Stage 1 Pilot portion to optimize intervention and achievecorrelational research aims
Experimental: Stage 2 Main Clinical Trial with random assignment	Behavioral: Real time fMRI neurofeedback During fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.

Arm

Intervention/Treatment

No Intervention: Stage 1

Pilot portion to optimize intervention and achievecorrelational research aims

Experimental: Stage 2

Main Clinical Trial with random assignment

Behavioral: Real time fMRI neurofeedback

During fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.

Outcome Measures

Primary Outcome Measures

Alcohol Craving [Acute, 1, 3, 6 months]
Self-report craving, change in cue reactivity
Alcohol Attention Bias [Acute, 1, 3, 6 months]
Socioemotional Alcohol Attention Task

Secondary Outcome Measures

Alcohol consumption [1, 3, 6 months]
Measured by alcohol timeline followback
Community functioning [1, 3, 6 months]
Measured by Drinker Inventory of Consequences, self-reported employment and residential stability
Antisocial behavior [1, 3, 6 months]
Specifically, self-reported crime and police contacts, and intimate partner aggression

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Stage 1:

INCLUSION CRITERIA:

21 to 65 years old
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)
AUD participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent SCID 5 diagnosis

EXCLUSION CRITERIA:

Significant history of head trauma or cranial surgery
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.
Physical health concern that would significantly impair or increase the risk of study participation.
Healthy volunteers only: Have fulfilled DSM-5 criteria for a current substance or alcohol use disorder
Female participants only: Currently pregnant
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
Any flag on the NIAAA MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)
History of non-substance related psychosis
Lack of experience with alcohol (defined as less than 3 lifetime drinks

Stage 2:

INCLUSION CRITERIA:

21 to 65 years old
Inpatient currently seeking treatment for alcohol use disorder

EXCLUSION CRITERIA:

Significant history of head trauma or cranial surgery,
History of neurological disease based on self-report and neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.
Physical health concern that would significantly impair or increase the risk of study participation.
Presence of any contraindication for fMRI as determined by the NIAAA MRI Safety Screening Questionnaire
Any flag on the NIAAA MRI Safety Screening Questionnaire, unless
History of non-substance related psychosis
Female participants only: Currently pregnant

Inpatients who have been admitted into the behavioral unit at the Clinical Center for AUD treatment, maybe considered for this study. Upon completion of consenting procedure, any data necessary (but not readily available) to determine eligibility maybe collected under this study. However, to avoid undue discomfort, burden, and inconvenience, this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data up to 30 days prior to the consenting date. Participants who do not satisfy any of the above criteria will not participate in the study procedures at the time. They may be re-scheduled for a future date(s) when they fulfill all inclusion/exclusionary criteria.