NCT07746154

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Feb 2028

First Submitted

Initial submission to the registry

July 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use DisorderEEG neurofeedback

Outcome Measures

Primary Outcomes (3)

  • Participant retention rate over 1 week

    Proportion of participants who complete all study visits

    one week

  • Proportion of participants experiencing adverse events during neurofeedback sessions over 1 week

    Number and severity of adverse events

    One week

  • Proportion of scheduled neurofeedback sessions completed over 1 week

    Proportion of scheduled neurofeedback sessions completed

    One week

Secondary Outcomes (2)

  • Change in alcohol craving (PACS total score) from baseline to Visit 3 (~1 week)

    One week

  • Change in alcohol consumption measured by Timeline Follow-Back (TLFB) from baseline (Visit 1) to post-intervention (Visit 3, ~1 week)

    One week

Study Arms (1)

Neurofeedback

EXPERIMENTAL
Device: EEG Neurofeedback

Interventions

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.

Neurofeedback

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 28936792BACKGROUND

  • Wan 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.

    PMID: 40798852BACKGROUND

  • Affan 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.

    PMID: 29778070BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Naomi Rosenblum

CONTACT

8572054415nrosenblum@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

August 4, 2026

Record last verified: 2026-07