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

NCT03535129 | Completed Results

• 2 other identifiers: 18009818-AA-0098
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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 to 65 who have an alcohol use disorder.
• Healthy volunteers ages 21 to 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.

Conditions

Healthy Volunteers; Alcohol Drinking Related Problems; Alcohol-Related Disorders

Keywords

Alcohol; Socioemotional; Functional Magnetic Resonance Imaging (fMRI); Neurofeedback; Drug Relapse

Outcome Measures

Primary Outcomes (5)

• Alcohol Attention Bias Signal - Stage 1

  Contrast in the estimated blood-oxygen-level-dependent (BOLD) response between the conditions of # 1) negative socioemotional cue paired with an alcohol cue, and #2) negative Socioemotional cue paired with a neutral cue during the fMRI brain scan. The contrast value was calculated by subtracting the BOLD response value for condition #1 from the BOLD response value from condition #2.

  On day of fMRI scan

• Change in Alcohol Craving - Stage 1

  Alcohol craving was measured using a modified version of the Alcohol Craving Questionnaire Short Form (ACQ-SF-R). The ACQ-SF-R is a 12-item assessment measuring craving for alcohol among alcohol users in the current context. Each item is scored on the scale of 1 (strongly disagree) to 7 (strongly agree). The total general craving score is derived by summing the score of all 12 items, then dividing by 12. Higher score indicates higher craving. The change measure was calculated as craving measured prior to the fMRI scan subtracted from craving measured post-scan.

  On day of fMRI scan

• Change in Alcohol Attention Bias - Stage 2

  Contrast in the estimated blood-oxygen-level-dependent (BOLD) response between the conditions of # 1) negative socioemotional cue paired with an alcohol cue, and #2) negative Socioemotional cue paired with a neutral cue during the fMRI brain scan. The contrast value was calculated by subtracting the BOLD response value for condition #1 from the BOLD response value from condition #2 for week one and week four. Analysis is the pre-post difference in BOLD contrast value from the pre-neurofeedback scan (week 1 scan) subtracted from the BOLD contrast value from the post-neurofeedback scan (week 4 scan).

  Week 4 - week 1

• Change in Alcohol Craving - Stage 2

  Alcohol craving was measured using a modified version of the Alcohol Craving Questionnaire Short Form (ACQ-SF-R). The ACQ-SF-R is a 12-item assessment measuring craving for alcohol among alcohol users in the current context. Each item is scored on the scale of 1 (strongly disagree) to 7 (strongly agree). The total general craving score is derived by summing the score of all 12 items, then dividing by 12. Higher score indicates higher craving. The change measure was calculated as craving measured prior to the fMRI scan subtracted from craving measured post-scan.

  On day of scan during week 1 and week 4

• Mean Alcohol Craving Score

  Alcohol craving was measured using a modified version of the Alcohol Craving Questionnaire Short Form (ACQ-SF-R). The ACQ-SF-R is a 12-item assessment measuring craving for alcohol among alcohol users in the current context. Each item is scored on the scale of 1 (strongly disagree) to 7 (strongly agree). The total general craving score is derived by summing the score of all 12 items, then dividing by 12. Higher score indicates higher craving. Analysis was done as the mean value for participants.

  1, 3, & 6 months after discharge

Study Arms (4)

Pilot: Stage 1, Participants with Alcohol Use Disorder

EXPERIMENTAL

Treatment-seeking adults meeting DSM-5 criteria for alcohol use disorder (AUD). Participants underwent a single fMRI brain scan during which they performed the socioemotional processing task while in the MRI scanner, prior to real time active neurofeedback (displaying the participant's own neural signal).

Behavioral: Real time fMRI neurofeedback

Pilot: Stage 1, Healthy Control Volunteer

EXPERIMENTAL

Medically and psychologically healthy control volunteers, without alcohol use disorder. Participants underwent a single fMRI brain scan during which they performed the socioemotional processing task while in the MRI scanner, prior to real time active neurofeedback (displaying the participant's own neural signal).

Behavioral: Real time fMRI neurofeedback

Stage 2, Participants with Alcohol Use Disorder, Neurofeedback

EXPERIMENTAL

Treatment-seeking adults meeting DSM-5 criteria for alcohol use disorder (AUD). Participants underwent two fMRI brain scans week 1 and week 4 of the study. During the week 1, participants underwent the fMRI brain scan during which they performed the socioemotional processing task while in the MRI scanner prior to the real time active neurofeedback (displaying the participant's own neural signal). During week 4, participants underwent the fMRI brain scan during which they performed the socioemotional processing task while in the MRI scanner, after the real time active neurofeedback (displaying the participant's own neural signal).

Behavioral: Real time fMRI neurofeedback

Stage 2, Participants with Alcohol Use Disorder, Sham

SHAM COMPARATOR

Treatment-seeking adults meeting DSM-5 criteria for alcohol use disorder (AUD). Participants underwent two fMRI brain scans week 1 and week 4 of the study. During the week 1, participants underwent the fMRI brain scan during which they performed the socioemotional processing task while in the MRI scanner prior to the real time sham neurofeedback (displaying a different participant's neural signal). During week 4, participants underwent the fMRI brain scan during which they performed the socioemotional processing task while in the MRI scanner, after the real time sham neurofeedback (displaying a different participant's neural signal).

Behavioral: Real time fMRI neurofeedback

Interventions

Real time fMRI neurofeedback BEHAVIORAL

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

Pilot: Stage 1, Healthy Control Volunteer; Pilot: Stage 1, Participants with Alcohol Use Disorder; Stage 2, Participants with Alcohol Use Disorder, Neurofeedback; Stage 2, Participants with Alcohol Use Disorder, Sham

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Stage 1:
• 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)
• Alcohol use disorder (AUD) participants only: Diagnosed with current moderate to severe alcohol use disorder according to most recent Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (SCID-5) diagnosis
• 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 neuro-abnormalities 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 the 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 three lifetime drinks reported in history and physical or on Lifetime Drinking History)
• Stage 2:
• to 65 years old

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Melanie Schwandt
• Organization: National Institute on Alcohol Abuse and Alcoholism

melanies@mail.nih.gov

1-301-451-6960

Study Officials

• Melanie L Schwandt, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: May 24, 2018
• Study Start: September 20, 2018
• Primary Completion: March 23, 2025
• Study Completion: March 23, 2025
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data from this study may be requested by other researchers after the completion of the primary endpoint and publication of results.
• Access Criteria: Data from this study may be requested by other researchers after the completion of the primary endpoint by contacting the principal investigator. De-identified data may be uploaded directly alongside publications as possible.

Locations

US (1)