Trial Outcomes & Findings for A Response Modulation Hypothesis of Socioemotional Processing Associated With Alcohol Use Disorder (NCT NCT03535129)

NCT ID: NCT03535129

Last Updated: 2026-04-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

On day of fMRI scan

Results posted on

2026-04-23

Participant Flow

Participant milestones

Participant milestones
Measure
Pilot: Stage 1, Participants With Alcohol Use Disorder
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).
Pilot: Stage 1, Healthy Control Volunteer
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).
Stage 2, Participants With Alcohol Use Disorder, Neurofeedback
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).
Stage 2, Participants With Alcohol Use Disorder, Sham
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).
Stage 1 - Pilot
STARTED
30
30
0
0
Stage 1 - Pilot
COMPLETED
30
28
0
0
Stage 1 - Pilot
NOT COMPLETED
0
2
0
0
Stage 2
STARTED
0
0
20
21
Stage 2
COMPLETED
0
0
12
15
Stage 2
NOT COMPLETED
0
0
8
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Pilot: Stage 1, Participants With Alcohol Use Disorder
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).
Pilot: Stage 1, Healthy Control Volunteer
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).
Stage 2, Participants With Alcohol Use Disorder, Neurofeedback
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).
Stage 2, Participants With Alcohol Use Disorder, Sham
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).
Stage 1 - Pilot
Withdrawal by Subject
0
1
0
0
Stage 1 - Pilot
Physician Decision
0
1
0
0
Stage 2
Adverse Event
0
0
1
0
Stage 2
Physician Decision
0
0
1
1
Stage 2
Withdrawal by Subject
0
0
4
3
Stage 2
Technical difficulties
0
0
2
2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pilot: Stage 1, Participants With Alcohol Use Disorder (ALC)
n=30 Participants
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).
Pilot: Stage 1, Healthy Control Volunteer (HCV)
n=30 Participants
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).
Stage 2, Participants With Alcohol Use Disorder, Neurofeedback
n=20 Participants
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).
Stage 2, Participants With Alcohol Use Disorder, Sham
n=21 Participants
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).
Total
n=101 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
0 Participants
n=7 Participants
0 Participants
n=3 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
n=60 Participants
30 Participants
n=56 Participants
20 Participants
n=116 Participants
21 Participants
n=7 Participants
101 Participants
n=3 Participants
Age, Categorical
>=65 years
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
0 Participants
n=7 Participants
0 Participants
n=3 Participants
Sex: Female, Male
Female
12 Participants
n=60 Participants
13 Participants
n=56 Participants
4 Participants
n=116 Participants
5 Participants
n=7 Participants
34 Participants
n=3 Participants
Sex: Female, Male
Male
18 Participants
n=60 Participants
17 Participants
n=56 Participants
16 Participants
n=116 Participants
16 Participants
n=7 Participants
67 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=60 Participants
4 Participants
n=56 Participants
6 Participants
n=116 Participants
0 Participants
n=7 Participants
15 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=60 Participants
25 Participants
n=56 Participants
14 Participants
n=116 Participants
20 Participants
n=7 Participants
84 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=60 Participants
1 Participants
n=56 Participants
0 Participants
n=116 Participants
1 Participants
n=7 Participants
2 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
0 Participants
n=7 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Asian
0 Participants
n=60 Participants
4 Participants
n=56 Participants
1 Participants
n=116 Participants
1 Participants
n=7 Participants
6 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
0 Participants
n=7 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=60 Participants
12 Participants
n=56 Participants
7 Participants
n=116 Participants
7 Participants
n=7 Participants
34 Participants
n=3 Participants
Race (NIH/OMB)
White
19 Participants
n=60 Participants
13 Participants
n=56 Participants
6 Participants
n=116 Participants
12 Participants
n=7 Participants
50 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=60 Participants
0 Participants
n=56 Participants
3 Participants
n=116 Participants
1 Participants
n=7 Participants
6 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=60 Participants
1 Participants
n=56 Participants
3 Participants
n=116 Participants
0 Participants
n=7 Participants
5 Participants
n=3 Participants

PRIMARY outcome

Timeframe: On day of fMRI scan

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Stage 2, Participants With Alcohol Use Disorder, Sham
n=25 Participants
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).
Pilot: Stage 1, Participants With Alcohol Use Disorder
n=27 Participants
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).
Alcohol Attention Bias Signal - Stage 1
Left Temporoparietal Junction (TPJ)
0.064501835 Arbitrary units (A.U)
Standard Deviation 0.281825924
0.183969647 Arbitrary units (A.U)
Standard Deviation 0.34868387
Alcohol Attention Bias Signal - Stage 1
Right Temporoparietal Junction (TPJ)
0.111716536 Arbitrary units (A.U)
Standard Deviation 0.515234536
0.012449894 Arbitrary units (A.U)
Standard Deviation 0.293952328
Alcohol Attention Bias Signal - Stage 1
Orbital Frontal Cortex (OFC)
0.135970228 Arbitrary units (A.U)
Standard Deviation 0.285163587
0.007121461 Arbitrary units (A.U)
Standard Deviation 0.327895448
Alcohol Attention Bias Signal - Stage 1
Anterior Cingulate Cortex (ACC)
0.112620872 Arbitrary units (A.U)
Standard Deviation 0.332702319
-0.015216812 Arbitrary units (A.U)
Standard Deviation 0.338332735
Alcohol Attention Bias Signal - Stage 1
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 9)
-0.011383586 Arbitrary units (A.U)
Standard Deviation 0.323403315
0.006437261 Arbitrary units (A.U)
Standard Deviation 0.50737507
Alcohol Attention Bias Signal - Stage 1
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 10)
0.104476342 Arbitrary units (A.U)
Standard Deviation 0.362396504
-0.013205257 Arbitrary units (A.U)
Standard Deviation 0.318677681
Alcohol Attention Bias Signal - Stage 1
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 11)
-0.061145134 Arbitrary units (A.U)
Standard Deviation 0.416462789
0.080610542 Arbitrary units (A.U)
Standard Deviation 0.37063007
Alcohol Attention Bias Signal - Stage 1
Left Amygdala
0.008899921 Arbitrary units (A.U)
Standard Deviation 0.298389161
0.019106567 Arbitrary units (A.U)
Standard Deviation 0.398518836
Alcohol Attention Bias Signal - Stage 1
Right Amygdala
0.076372304 Arbitrary units (A.U)
Standard Deviation 0.539774953
0.220618513 Arbitrary units (A.U)
Standard Deviation 0.499181653
Alcohol Attention Bias Signal - Stage 1
Posterior Cingulate Cortex (DPCC) Dorsal (Brodmann's Area 23)
-0.102112951 Arbitrary units (A.U)
Standard Deviation 0.46095139
-0.003441241 Arbitrary units (A.U)
Standard Deviation 0.362168586
Alcohol Attention Bias Signal - Stage 1
Posterior Cingulate Cortex (DPCC) Dorsal (Brodmann's Area 31)
-0.046216303 Arbitrary units (A.U)
Standard Deviation 0.487777574
-0.088683965 Arbitrary units (A.U)
Standard Deviation 0.367981568
Alcohol Attention Bias Signal - Stage 1
Left Insula
0.081265483 Arbitrary units (A.U)
Standard Deviation 0.241184165
-0.085572187 Arbitrary units (A.U)
Standard Deviation 0.277603935
Alcohol Attention Bias Signal - Stage 1
Right Insula
0.032656324 Arbitrary units (A.U)
Standard Deviation 0.198707016
0.086284786 Arbitrary units (A.U)
Standard Deviation 0.282598996
Alcohol Attention Bias Signal - Stage 1
Superior Temporal Gyrus (STG)
0.061087056 Arbitrary units (A.U)
Standard Deviation 0.232965421
0.055685878 Arbitrary units (A.U)
Standard Deviation 0.384959716
Alcohol Attention Bias Signal - Stage 1
Medial Temporal Gyrus (MTG)
-0.068502781 Arbitrary units (A.U)
Standard Deviation 0.350253829
0.097750836 Arbitrary units (A.U)
Standard Deviation 0.312679212

PRIMARY outcome

Timeframe: On day of fMRI scan

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Stage 2, Participants With Alcohol Use Disorder, Sham
n=28 Participants
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).
Pilot: Stage 1, Participants With Alcohol Use Disorder
n=30 Participants
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).
Change in Alcohol Craving - Stage 1
0.12 units on a scale
Standard Deviation 0.46
0.02 units on a scale
Standard Deviation 0.58

PRIMARY outcome

Timeframe: Week 4 - week 1

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Stage 2, Participants With Alcohol Use Disorder, Sham
n=11 Participants
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).
Pilot: Stage 1, Participants With Alcohol Use Disorder
n=9 Participants
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).
Change in Alcohol Attention Bias - Stage 2
Right Temporoparietal Junction (TPJ)
0.065423193 Arbitrary units (A.U)
Standard Deviation 0.713271388
0.061200551 Arbitrary units (A.U)
Standard Deviation 0.773585752
Change in Alcohol Attention Bias - Stage 2
Orbital Frontal Cortex (OFC)
0.184816519 Arbitrary units (A.U)
Standard Deviation 0.318534026
-0.231955025 Arbitrary units (A.U)
Standard Deviation 0.823091458
Change in Alcohol Attention Bias - Stage 2
Anterior Cingulate Cortex (ACC)
-0.009628402 Arbitrary units (A.U)
Standard Deviation 0.542949389
0.575760441 Arbitrary units (A.U)
Standard Deviation 0.747864551
Change in Alcohol Attention Bias - Stage 2
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 9)
0.288568992 Arbitrary units (A.U)
Standard Deviation 0.50816038
0.420713313 Arbitrary units (A.U)
Standard Deviation 0.66484282
Change in Alcohol Attention Bias - Stage 2
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 10)
0.111225034 Arbitrary units (A.U)
Standard Deviation 0.423595514
0.113213063 Arbitrary units (A.U)
Standard Deviation 0.656196322
Change in Alcohol Attention Bias - Stage 2
Right Amygdala
0.104729369 Arbitrary units (A.U)
Standard Deviation 0.659124983
0.20689625 Arbitrary units (A.U)
Standard Deviation 0.71644675
Change in Alcohol Attention Bias - Stage 2
Posterior Cingulate Cortex (DPCC) Dorsal (Brodmann's Area 23)
0.270314656 Arbitrary units (A.U)
Standard Deviation 0.367829968
-0.249853897 Arbitrary units (A.U)
Standard Deviation 0.420351659
Change in Alcohol Attention Bias - Stage 2
Posterior Cingulate Cortex (DPCC) Dorsal (Brodmann's Area 31)
-0.152840254 Arbitrary units (A.U)
Standard Deviation 0.703493163
-0.00584145 Arbitrary units (A.U)
Standard Deviation 0.577968122
Change in Alcohol Attention Bias - Stage 2
Left Insula
0.042388635 Arbitrary units (A.U)
Standard Deviation 0.336752509
-0.027365188 Arbitrary units (A.U)
Standard Deviation 0.217034981
Change in Alcohol Attention Bias - Stage 2
Right Insula
-0.009776571 Arbitrary units (A.U)
Standard Deviation 0.458290057
-0.0792186 Arbitrary units (A.U)
Standard Deviation 0.304977976
Change in Alcohol Attention Bias - Stage 2
Superior Temporal Gyrus (STG)
-0.230101298 Arbitrary units (A.U)
Standard Deviation 0.617054688
0.15895405 Arbitrary units (A.U)
Standard Deviation 0.791140358
Change in Alcohol Attention Bias - Stage 2
Medial Temporal Gyrus (MTG)
0.354600222 Arbitrary units (A.U)
Standard Deviation 0.283388715
-0.032349013 Arbitrary units (A.U)
Standard Deviation 0.937345564
Change in Alcohol Attention Bias - Stage 2
Left Temporoparietal Junction (TPJ)
-0.16982444 Arbitrary units (A.U)
Standard Deviation 0.507555922
0.04975482 Arbitrary units (A.U)
Standard Deviation 0.501069128
Change in Alcohol Attention Bias - Stage 2
Medial Prefrontal Cortex (mPFC) (Brodmann's Area 11)
0.32901542 Arbitrary units (A.U)
Standard Deviation 0.768852637
0.192920751 Arbitrary units (A.U)
Standard Deviation 1.163170559
Change in Alcohol Attention Bias - Stage 2
Left Amygdala
0.137116835 Arbitrary units (A.U)
Standard Deviation 0.448289159
0.29012645 Arbitrary units (A.U)
Standard Deviation 0.307965135

PRIMARY outcome

Timeframe: On day of scan during week 1 and week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Stage 2, Participants With Alcohol Use Disorder, Sham
n=20 Participants
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).
Pilot: Stage 1, Participants With Alcohol Use Disorder
n=17 Participants
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).
Change in Alcohol Craving - Stage 2
Week 1
-0.50 units on a scale
Standard Deviation 0.96
-0.35 units on a scale
Standard Deviation 0.78
Change in Alcohol Craving - Stage 2
Week 4
-0.04 units on a scale
Standard Deviation 0.75
-0.03 units on a scale
Standard Deviation 0.23

PRIMARY outcome

Timeframe: 1, 3, & 6 months after discharge

Population: Analysis included participants enrolled in Stage 2 of the protocol only, as it was pre-specified that only Stage 2 participants would be assessed during a follow-up period. Furthermore, analysis included those participants who presented for follow up visits for each timepoint.

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.

Outcome measures

Outcome measures
Measure
Stage 2, Participants With Alcohol Use Disorder, Sham
n=9 Participants
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).
Pilot: Stage 1, Participants With Alcohol Use Disorder
n=12 Participants
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).
Mean Alcohol Craving Score
6 months after discharge
3.11 units on a scale
Standard Deviation 1.85
2.94 units on a scale
Standard Deviation 1.37
Mean Alcohol Craving Score
1 month after discharge
2.42 units on a scale
Standard Deviation 1.13
3.12 units on a scale
Standard Deviation 0.99
Mean Alcohol Craving Score
3 months after discharge
3.60 units on a scale
Standard Deviation 2.13
3.69 units on a scale
Standard Deviation 2.08

Adverse Events

Pilot: Stage 1, Participants With Alcohol Use Disorder (ALC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Pilot: Stage 1, Healthy Control Volunteer (HCV)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Stage 2, Participants With Alcohol Use Disorder, Neurofeedback

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Stage 2, Participants With Alcohol Use Disorder, Sham

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Pilot: Stage 1, Participants With Alcohol Use Disorder (ALC)
n=30 participants at risk
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).
Pilot: Stage 1, Healthy Control Volunteer (HCV)
n=30 participants at risk
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).
Stage 2, Participants With Alcohol Use Disorder, Neurofeedback
n=20 participants at risk
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).
Stage 2, Participants With Alcohol Use Disorder, Sham
n=21 participants at risk
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).
Psychiatric disorders
Anxiety
0.00%
0/30 • From enrollment in the study up through 6-month follow-up
0.00%
0/30 • From enrollment in the study up through 6-month follow-up
5.0%
1/20 • From enrollment in the study up through 6-month follow-up
0.00%
0/21 • From enrollment in the study up through 6-month follow-up
Psychiatric disorders
Emotional distress
0.00%
0/30 • From enrollment in the study up through 6-month follow-up
0.00%
0/30 • From enrollment in the study up through 6-month follow-up
0.00%
0/20 • From enrollment in the study up through 6-month follow-up
4.8%
1/21 • From enrollment in the study up through 6-month follow-up

Additional Information

Dr Melanie Schwandt

National Institute on Alcohol Abuse and Alcoholism

Phone: 1-301-451-6960

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place