Healthy VolunteersNCT03535129

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

A study testing Real time fMRI neurofeedback in people with Healthy Volunteers and Alcohol Drinking Related Problems, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Healthy Volunteers, Alcohol Drinking Related Problems, Alcohol-Related Disorders
What is being tested?: Real time fMRI neurofeedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 1 siteUnited States
Study dates: 20 Sep 2018to 23 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage 1:
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)
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
21 to 65 years old
Inpatient currently seeking treatment for alcohol use disorder

Who cannot join

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

Show all 20Show fewer

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:
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 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
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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 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.

Read the detailed description

Study Description:

In the first stage, participants will undergo functional magnetic resonance imaging (fMRI) while looking at socioemotional stimuli and alcohol cues and will pilot a neurofeedback training protocol. Personality traits and executive function will also be investigated. This is the pilot stage that will be used to test and refine the neurofeedback parameters and procedure, and to compare neural responses and alcohol attention bias between participants with AUD and healthy controls.

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)

Conditions: Healthy Volunteers, Alcohol Drinking Related Problems, Alcohol-Related Disorders
Being tested: Real time fMRI neurofeedback
Keywords: Alcohol, Socioemotional, Functional Magnetic Resonance Imaging (fMRI), Neurofeedback, Drug Relapse
Medical subject headings: Alcohol-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03535129
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: Behavioral: Real time fMRI neurofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 1, 3, & 6 months after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 201823 Mar 2025

First posted24 May 2018
Study start20 Sep 2018
Primary completion23 Mar 2025
Study completion23 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03535129
Sponsor's protocol ID: 180098
Other IDs: 18-AA-0098
Status last verified: Apr 2026
First submitted: 23 May 2018
Last updated: 23 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Study results will be posted on ClinicalTrials.gov and published in peer-reviewed journals. De-identified data from this study may be shared with NIH collaborators and qualified researchers after completion of the primary analyses.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating a Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder
ClinicalTrials.gov ID: NCT03535129
Acronym / sponsor ID: 180098
Conditions: Healthy Volunteers, Alcohol Drinking Related Problems, Alcohol-Related Disorders
Keywords: Alcohol, Socioemotional, Functional Magnetic Resonance Imaging (fMRI), Neurofeedback, Drug Relapse
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: National Institutes of Health Clinical Center (CC)US National Institutes of Health
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 20 Sep 2018 (actual)
Primary completion: 23 Mar 2025 (actual)
Study completion: 23 Mar 2025 (actual)
First posted: 24 May 2018 (actual)
Results: Posted 23 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

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.

Detailed description

Study Description:

Objectives:

Endpoints:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Pilot: Stage 1, Participants with Alcohol Use Disorder	Experimental	Behavioral: Real time fMRI neurofeedbackTreatment-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).
Pilot: Stage 1, Healthy Control Volunteer	Experimental	Behavioral: Real time fMRI neurofeedbackMedically 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).
Stage 2, Participants with Alcohol Use Disorder, Neurofeedback	Experimental	Behavioral: Real time fMRI neurofeedbackTreatment-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).
Stage 2, Participants with Alcohol Use Disorder, Sham	Sham comparator	Behavioral: Real time fMRI neurofeedbackTreatment-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).

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Real time fMRI neurofeedbackDuring fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.	Behavioural	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

Primary outcome

Alcohol Attention Bias Signal - Stage 1
Time frame: On day of fMRI scan
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.
Change in Alcohol Craving - Stage 1
Time frame: On day of fMRI scan
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.
Change in Alcohol Attention Bias - Stage 2
Time frame: Week 4 - week 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 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).
Change in Alcohol Craving - Stage 2
Time frame: On day of scan during week 1 and week 4
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.
Mean Alcohol Craving Score
Time frame: 1, 3, & 6 months after discharge
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.

Results and safety

Results posted to the registry on 23 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pilot: Stage 1, Participants With Alcohol Use Disorder	30	30
Pilot: Stage 1, Healthy Control Volunteer	30	28
Stage 2, Participants With Alcohol Use Disorder, Neurofeedback	0	0
Stage 2, Participants With Alcohol Use Disorder, Sham	0	0

Primary outcome: Alcohol Attention Bias Signal - Stage 1

Time frame: On day of fMRI scan. Mean (Standard Deviation). Unit: Arbitrary units (A.U)

Measure	Pilot: Stage 1, Participants With Alcohol Use Disorder n = 27	Pilot: Stage 1, Healthy Control Volunteer n = 25
Orbital Frontal Cortex (OFC)	0.007121461 (0.327895448)	0.135970228 (0.285163587)
Anterior Cingulate Cortex (ACC)	-0.015216812 (0.338332735)	0.112620872 (0.332702319)
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 9)	0.006437261 (0.50737507)	-0.011383586 (0.323403315)
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 10)	-0.013205257 (0.318677681)	0.104476342 (0.362396504)
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 11)	0.080610542 (0.37063007)	-0.061145134 (0.416462789)
Left Amygdala	0.019106567 (0.398518836)	0.008899921 (0.298389161)
Right Amygdala	0.220618513 (0.499181653)	0.076372304 (0.539774953)
Posterior Cingulate Cortex (DPCC) Dorsal (Brodmann's Area 23)	-0.003441241 (0.362168586)	-0.102112951 (0.46095139)

Population analysed: Analysis included participants enrolled in Stage 1 of the protocol only, as it was pre-specified that Stage 1 participants would complete a single scan only. Furthermore, analysis included only those participants who completed the fMRI brain scan, had good quality imaging data, and who successfully completed the socio-emotional processing behavioral task in the pilot study.

Primary outcome: Change in Alcohol Craving - Stage 1

Time frame: On day of fMRI scan. Mean (Standard Deviation). Unit: units on a scale

Measure	Pilot: Stage 1, Participants With Alcohol Use Disorder (ALC) n = 30	Pilot: Stage 1, Healthy Control Volunteer (HCV) n = 28
Value	0.02 (0.58)	0.12 (0.46)

Population analysed: Analysis included participants enrolled in Stage 1 of the protocol only, as it was pre-specified that Stage 1 participants would complete a single scan only. Furthermore, analysis included only those participants who completed the fMRI brain scan and who completed both the pre- and post-scan craving assessments.

Primary outcome: Change in Alcohol Attention Bias - Stage 2

Time frame: Week 4 - week 1. Mean (Standard Deviation). Unit: Arbitrary units (A.U)

Measure	Stage 2, Participants With Alcohol Use Disorder, Neurofeedback n = 9	Stage 2, Participants With Alcohol Use Disorder, Sham n = 11
Orbital Frontal Cortex (OFC)	-0.231955025 (0.823091458)	0.184816519 (0.318534026)
Anterior Cingulate Cortex (ACC)	0.575760441 (0.747864551)	-0.009628402 (0.542949389)
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 9)	0.420713313 (0.66484282)	0.288568992 (0.50816038)
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 10)	0.113213063 (0.656196322)	0.111225034 (0.423595514)
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 11)	0.192920751 (1.163170559)	0.32901542 (0.768852637)
Left Amygdala	0.29012645 (0.307965135)	0.137116835 (0.448289159)
Right Amygdala	0.20689625 (0.71644675)	0.104729369 (0.659124983)
Posterior Cingulate Cortex (DPCC) Dorsal (Brodmann's Area 23)	-0.249853897 (0.420351659)	0.270314656 (0.367829968)

Population analysed: Analysis included participants enrolled in Stage 2 of the protocol only, as it was pre-specified that Stage 2 participants would complete two scans. Furthermore, analysis included only those participants who completed both the pre-neurofeedback and post-neurofeedback fMRI scans, had good quality imaging data for both scans, and who successfully completed the socioemotional processing behavioral task during both scans.

Primary outcome: Change in Alcohol Craving - Stage 2

Time frame: On day of scan during week 1 and week 4. Mean (Standard Deviation). Unit: units on a scale

Measure	Stage 2, Participants With Alcohol Use Disorder, Neurofeedback n = 17	Stage 2, Participants With Alcohol Use Disorder, Sham n = 20
Week 1	-0.35 (0.78)	-0.50 (0.96)
Week 4	-0.03 (0.23)	-0.04 (0.75)

Population analysed: Analysis included participants enrolled in Stage 2 of the protocol only, as it was pre-specified that Stage 2 participants would complete two scans. For week 1, analysis included only those participants who completed the pre-neurofeedback fMRI scan and who completed both the pre- and post-scan craving assessments. For week 4, analysis included only those participants who completed the post-neurofeedback fMRI scan and who completed both the pre- and post-scan craving assessments.

Adverse events

Time frame: From enrollment in the study up through 6-month follow-up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pilot: Stage 1, Participants With Alcohol Use Disorder (ALC)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Pilot: Stage 1, Healthy Control Volunteer (HCV)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Stage 2, Participants With Alcohol Use Disorder, Neurofeedback	0 of 20 (0%)	1 of 20 (5%)	0 of 20
Stage 2, Participants With Alcohol Use Disorder, Sham	0 of 21 (0%)	1 of 21 (4.8%)	1 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Study results will be posted on ClinicalTrials.gov and published in peer-reviewed journals. De-identified data from this study may be shared with NIH collaborators and qualified researchers after completion of the primary analyses.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melanie L Schwandt, Ph.D. principal investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Attention Bias Signal - Stage 1 (time frame: On day of fMRI scan). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.