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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535129
• Other study ID #: 180098
• Secondary ID: 18-AA-0098
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: June 21, 2024

Study information

• Verified date: May 21, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Beth A Lee, R.N.
• Phone: (301) 451-6964
• Email: beth.lee[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Description:

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.

Objectives:

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 socioemotional processing in individuals with alcohol use disorder and investigate how moderating that deficit affects socioemotional processing and negative drinking consequences.

Endpoints:

Brain engagement during exposure to socioemotional stimuli, alcohol cues, and neurofeedback training (fMRI-Scan Portion)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 21, 2024
• Est. primary completion date: June 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

• INCLUSION AND EXCLUSION 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

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 reported in history and physical or on Lifetime Drinking History)

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 ferromagnetic objects in the body that may be aversively

affected by or contraindicated for MRI as determined by the NIAAA MRI Safety Screening Questionnaire

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

6. History of non-substance related psychosis

7. 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.

We will utilize SCID diagnoses (from other studies such as 14-AA-0181) to determine AUD diagnosis and any potential Axis I disorders. However, for inpatients, since the nursing practice is initially focused on patient detoxification and treatment, the SCID diagnoses might not always take place within the first week of the patient admission to the alcohol unit. This could seriously hamper the subject recruitment in the second stage of this study. We will conduct the MR scan of eligible participants (based on the above inclusion/exclusion criterion) according to study timeline regardless of the availability of SCID diagnoses.

Inpatients are admitted based on the clinical opinion of medical staff that the individual has a pattern of alcohol use disorder. We will enroll inpatients with this opinion but the SCID diagnoses will be completed in order to have consistent research data on symptomology and severity, and to use any potential Axis I disorder as a study confound. Additionally, we will collect information on medications being taken by patients currently or within the last month, including dose, schedule, and timeline. This will be used as a covariate in the statistical design to control for variation associated with these medications.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Drinking Related Problems
• Alcohol-Related Disorders
• Alcoholism
• Healthy Volunteers

Intervention

Behavioral:
• Real time fMRI neurofeedback
During fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Craving	Self-report craving, change in cue reactivity	Acute, 1, 3, 6 months
Primary	Alcohol Attention Bias	Socioemotional Alcohol Attention Task	Acute, 1, 3, 6 months
Secondary	Alcohol consumption	Measured by alcohol timeline followback	1, 3, 6 months
Secondary	Community functioning	Measured by Drinker Inventory of Consequences, self-reported employment and residential stability	1, 3, 6 months
Secondary	Antisocial behavior	Specifically, self-reported crime and police contacts, and intimate partner aggression	1, 3, 6 months

External Links

•   NIH Clinical Center Detailed Web Page