Alcohol Use Disorder (AUD)NeurofeedbackNCT07746154
Alpha Down Electroencephalography (EEG) Neurofeedback for Alcohol Use Disorder: Feasibility Trial
A study testing EEG Neurofeedback in people with Alcohol Use Disorder (AUD), run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- EEG Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ages 18-65
- Meets DSM-5 criteria for current Alcohol Use Disorder
- Willing and able to provide informed consent
- Alcohol consumption within the past 30 days
- Not requiring inpatient withdrawal management at the time of enrollment
Who cannot join
- 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 electroencephalography (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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Alpha Down EEG Neurofeedback for Alcohol Use Disorder: Feasibility Trial
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.
Read the 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- EEG Neurofeedback
- Keywords
- Alcohol Use Disorder, EEG neurofeedback
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG NeurofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Not described Receives: Device: EEG Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant retention rate over 1 week
Proportion of participants who complete all study visits
Measured: one week
Proportion of participants experiencing adverse events during neurofeedback sessions over 1 week
Number and severity of adverse events
Measured: One week
Proportion of scheduled neurofeedback sessions completed over 1 week
Proportion of scheduled neurofeedback sessions completed
Measured: One week
Secondary outcomes (2)
Change in alcohol craving (Penn Alcohol Craving Scale [PACS] total score) from baseline to Visit 3 (~1 week)
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS). PACS total scores range from 0 to 30, with higher scores indicating greater alcohol craving. Change in PACS total score from baseline to Visit 3 (~1 week) will be analyzed.
Measured: One week
Change in alcohol consumption measured by Timeline Follow-Back (TLFB) from baseline (Visit 1) to post-intervention (Visit 3, ~1 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.
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Terechin, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746154
- Sponsor's protocol ID
- 2026P000000
- Acronym
- Neurofeedback
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no current plan to make de-identified individual participant data collected in this study available to researchers outside the study team.
Publications
Imperatori C, Della Marca G, Amoroso N, Maestoso G, Valenti EM, Massullo C, Carbone GA, Contardi A, Farina B. Alpha/Theta Neurofeedback Increases Mentalization and Default Mode Network Connectivity in a Non-Clinical Sample. Brain Topogr. 2017 Nov;30(6):822-831. doi: 10.1007/s10548-017-0593-8. Epub 2017 Sep 21.
PubMed 28936792Wan H, Chen B, Li X, Bu J. Effect of EEG neurofeedback therapy on addiction disorders: A systematic review and meta-analysis. Addiction. 2026 Feb;121(2):225-238. doi: 10.1111/add.70164. Epub 2025 Aug 12.
PubMed 40798852Affan RO, Huang S, Cruz SM, Holcomb LA, Nguyen E, Marinkovic K. High-intensity binge drinking is associated with alterations in spontaneous neural oscillations in young adults. Alcohol. 2018 Aug;70:51-60. doi: 10.1016/j.alcohol.2018.01.002. Epub 2018 Jan 8.
PubMed 29778070
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha Down EEG Neurofeedback for Alcohol Use Disorder: Feasibility Trial
- ClinicalTrials.gov ID
- NCT07746154
- Acronym / sponsor ID
- Neurofeedback / 2026P000000
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Use Disorder, EEG neurofeedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: EEG Neurofeedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ages 18-65
- Meets DSM-5 criteria for current Alcohol Use Disorder
- Willing and able to provide informed consent
- Alcohol consumption within the past 30 days
- Not requiring inpatient withdrawal management at the time of enrollment
Key exclusion criteria (7 listed)
- 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 electroencephalography (EEG) procedures
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 |
|---|---|---|
| EEG NeurofeedbackParticipants 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. | Device | Neurofeedback |
Primary outcome
Participant retention rate over 1 week
Time frame: one week
Proportion of participants who complete all study visits
Proportion of participants experiencing adverse events during neurofeedback sessions over 1 week
Time frame: One week
Number and severity of adverse events
Proportion of scheduled neurofeedback sessions completed over 1 week
Time frame: One week
Proportion of scheduled neurofeedback sessions completed
2 secondary outcomes
Change in alcohol craving (Penn Alcohol Craving Scale [PACS] total score) from baseline to Visit 3 (~1 week)
Time frame: One week
Change in alcohol consumption measured by Timeline Follow-Back (TLFB) from baseline (Visit 1) to post-intervention (Visit 3, ~1 week)
Time frame: One week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 28936792Imperatori C, Della Marca G, Amoroso N, Maestoso G, Valenti EM, Massullo C, Carbone GA, Contardi A, Farina B. Alpha/Theta Neurofeedback Increases Mentalization and Default Mode Network Connectivity in a Non-Clinical Sample. Brain Topogr. 2017 Nov;30(6):822-831. doi: 10.1007/s10548-017-0593-8. Epub 2017 Sep 21.
- Background: PubMed 40798852Wan H, Chen B, Li X, Bu J. Effect of EEG neurofeedback therapy on addiction disorders: A systematic review and meta-analysis. Addiction. 2026 Feb;121(2):225-238. doi: 10.1111/add.70164. Epub 2025 Aug 12.
- Background: PubMed 29778070Affan RO, Huang S, Cruz SM, Holcomb LA, Nguyen E, Marinkovic K. High-intensity binge drinking is associated with alterations in spontaneous neural oscillations in young adults. Alcohol. 2018 Aug;70:51-60. doi: 10.1016/j.alcohol.2018.01.002. Epub 2018 Jan 8.
- Individual participant dataSharing planned: No. There is no current plan to make de-identified individual participant data collected in this study available to researchers outside the study team.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing EEG Neurofeedback in people with Alcohol Use Disorder (AUD), run by Brigham and Women's Hospital.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi Rosenblum (8572054415, nrosenblum@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention rate over 1 week (time frame: one week). The study lists 3 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 NCT07746154, which also lists 3 linked publications.
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 1 Oct 2026.