Alcohol Use Disorder (AUD)
Conditions
Keywords
Alcohol Use Disorder, EEG neurofeedback
Brief summary
This pilot study is testing a short brain training program called neurofeedback in adults with alcohol use disorder. Participants will complete three sessions over about one week. The goal is to learn if this approach is easy to complete, well tolerated, and acceptable to participants. We will also explore whether it is associated with changes in alcohol cravings and drinking.
Detailed description
Alcohol use disorder (AUD) is a common condition, and many individuals do not respond fully to existing treatments. Neurofeedback is a non-invasive method that uses real-time electroencephalography (EEG) signals to provide feedback, allowing individuals to learn to modulate their brain activity. This pilot study will evaluate a brief EEG-based neurofeedback intervention in adults with AUD. Participants will complete three in-person sessions over approximately one week. During each session, EEG sensors are placed on the scalp to measure brain activity, and participants receive real-time feedback based on these signals. The neurofeedback protocol targets downregulation of alpha-band activity (8-12 Hz). This approach differs from traditional alpha-theta neurofeedback and is intended to target patterns of brain activity related to attention, inhibitory control, and craving. The primary aim is to assess feasibility, tolerability, and acceptability. Feasibility will be evaluated through recruitment, retention, and session completion. Tolerability will be assessed by monitoring adverse events, and acceptability will be assessed through participant-reported experience. Exploratory outcomes will include changes in alcohol craving and alcohol use based on self-report measures. These analyses are exploratory and intended to inform future studies.
Interventions
DEVICEEEG Neurofeedback
Participants will receive a brief course of EEG-based neurofeedback consisting of three sessions over approximately one week. During each session, scalp electrodes are placed to record brain activity using electroencephalography (EEG). Real-time feedback is provided to guide participants in modulating their brain activity. The neurofeedback protocol targets downregulation of alpha-band activity (8-12 Hz). Training is delivered using a standardized protocol with real-time visual and/or auditory feedback. Each session lasts approximately 20 minutes, with additional time for setup and brief assessments.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Adults ages 18-65 Meets DSM-5 criteria for current Alcohol Use Disorder Willing and able to provide informed consent Participants must report alcohol consumption within the past 30 days. Not requiring inpatient withdrawal management at the time of enrollment
Exclusion criteria
History of epilepsy or seizure disorder (excluding uncomplicated alcohol withdrawal seizures) Current psychosis, mania, or acute suicidality, or any psychiatric condition that would impair the ability to provide informed consent or safely participate Acute alcohol intoxication at the time of study visits (as determined by breathalyzer) Pregnancy or breastfeeding Implanted electronic medical devices or metal in the head (excluding dental work), if incompatible with EEG procedures Severe cognitive impairment interfering with informed consent or participation Any medical or psychiatric condition that, in the opinion of the investigators, would make participation unsafe or interfere with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention rate over 1 week | one week | Proportion of participants who complete all study visits |
| Proportion of participants experiencing adverse events during neurofeedback sessions over 1 week | One week | Number and severity of adverse events |
| Proportion of scheduled neurofeedback sessions completed over 1 week | One week | Proportion of scheduled neurofeedback sessions completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in alcohol craving (PACS total score) from baseline to Visit 3 (~1 week) | One week | Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS). Change in total PACS score from baseline to the final visit will be analyzed. |
| Change in alcohol consumption measured by Timeline Follow-Back (TLFB) from baseline (Visit 1) to post-intervention (Visit 3, ~1 week) | One week | Alcohol consumption will be assessed using the Timeline Follow-Back (TLFB) method. Change in number of standard drinks over the assessment period from baseline to the final visit will be analyzed. |
Contacts
CONTACTNaomi Rosenblum
Outcome results
None listed