NCT04252755

Brief Summary

The purpose of this study is to investigate the effects of neurofeedback training on measures of cognitive control and alcohol motivation among young adults who drink alcohol on a regular basis. Neurofeedback is a cognitive training technique that uses portable electroencephalography (EEG) technology to adjust brain activity through immediate sensory feedback. This study is using a type of EEG device called a MuseTM headset that monitors ongoing brain activity and synchronizes this information with a mindfulness training app on a mobile device. This study is a pilot study to examine the feasibility and effects of neurofeedback training in a sample of young adults. Future studies may use similar protocols with people who have substance use disorders or other mental health disorders.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 30, 2020

Last Update Submit

February 3, 2023

Conditions

Alcohol Drinking

Keywords

Electroencephalography (EEG)NeurofeedbackAlcohol UseCognition

Outcome Measures

Primary Outcomes (3)

  • Alcohol motivation

    Alcohol demand will be assessed via a hypothetical purchase task measuring self-reported consumption of alcohol across a range of prices. Primary dependent measure of this task is the amount of alcohol purchased and money spent.

    14 days

  • Alcohol approach/avoidance bias

    Approach-avoidance bias will be assessed via an implicit approach/avoidance task involving pushing or pulling images closer/farther away using a joystick. Primary dependent measure from this task is latency of response to alcohol vs. neutral images for the approach and avoidance conditions.

    14 days

  • Alcohol craving

    Subjective alcohol craving will be assessed via a visual analog scale (0-100, with 100 equal to maximum craving)

    14 days

Secondary Outcomes (3)

  • Behavioural inhibition

    14 days

  • Risky decision-making

    14 days

  • Interference control

    14 days

Study Arms (1)

EEG Neurofeedback

OTHER

Within-subjects sessions of EEG neurofeedback

Behavioral: EEG Neurofeedback

Interventions

EEG NeurofeedbackBEHAVIORAL

Participants will undergo a baseline (pre) session, then be scheduled for 8 sessions of NFB, and finish with another session (post) after completion of all NFB sessions.

EEG Neurofeedback

Eligibility Criteria

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

You may qualify if:

  • Current undergraduate student, can be registered in the SONA research participant pool
  • years or older
  • At least one self-reported heavy drinking episode in the last two weeks (e.g., consumption of 5/4+ alcoholic drinks in a single drinking episode for men/women).

You may not qualify if:

  • History of stroke, seizures, or traumatic brain injury
  • Any history of severe psychiatric disorders, including schizophrenia-spectrum, bipolar disorder, Post-traumatic stress disorder.
  • Presence of skin conditions/headwear that cannot be removed on the forehead/scalp that could interfere with EEG signal (e.g., open cuts, eczema, heavy acne, or psoriasis)
  • Greater than weekly use of cannabis or greater than monthly use of other illicit drugs (e.g. cocaine, methamphetamine, opioids, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Michael Amlung, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study will utilize a pre-post within-subjects design. All participants will undergo a baseline (pre) session, then be scheduled for 8 sessions of neurofeedback, and finish with another session (post) after completion of all neurofeedback sessions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

CA(1)