Alcohol DrinkingNCT04252755
Enhancing Brain Processing Via Neurofeedback in Addictive Disorders
A study testing EEG Neurofeedback in people with Alcohol Drinking, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- EEG Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current undergraduate student, can be registered in the SONA research participant pool
- 18 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).
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Brain Processing Via Neurofeedback in Addictive Disorders: A Pilot Study
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.
Read the detailed description
The NFB studies conducted to date have utilized a wide range of methodologies and NFB training protocols. The outcome measures of NFB efficacy have also varied widely. As mentioned above, the studies also used expensive, non-portable equipment which may limit the application of NFB in treatment settings. This study seeks to address these limitations by using a commercially-available neurotechnology, the Muse™ headband by InteraXon (Toronto, ON, Canada) and using their standard NFB protocol built into the device application. This will maximize the standardization and portability of the NFB as essentially an "out of the box" intervention. The outcome measures will also capture multiple relevant domains, including clinical outcomes (e.g., drinking motivation) and neurocognitive performance (e.g., cognitive control / response inhibition).
The purpose of this study is to investigate the effects of NFB training on measures of cognitive control and alcohol motivation among young adults who engage in heavy episodic drinking (defined as exceeding 4+/5+ drinks per occasion for men/women).
The study will examine whether NFB reduces motivation/attention and craving for alcohol and attentional bias to alcohol-related cues. The primary outcome will be assessed by changes in the alcohol purchase task and approach/avoidance task, which participants will complete pre- and post-NFB training.
A secondary outcome is to determine whether NFB results in transfer of heightened fronto-cortical activity to improvements on general executive functioning following 8 sessions of NFB training. The secondary outcome will be assessed via changes in neurocognitive tasks assessing behavioural inhibition, risky decision making, and executive functioning, all of which will be administered pre- and post-NFB training.
- Conditions
- Alcohol Drinking
- Being tested
- EEG Neurofeedback
- Keywords
- Electroencephalography (EEG), Neurofeedback, Alcohol Use, Cognition
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG NeurofeedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EEG Neurofeedback | Other | Within-subjects sessions of EEG neurofeedback Receives: Behavioral: EEG Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Alcohol craving
Subjective alcohol craving will be assessed via a visual analog scale (0-100, with 100 equal to maximum craving)
Measured: 14 days
Secondary outcomes (3)
Behavioural inhibition
Behavioural inhibition will be assessed via computerized task of inhibitory control (go/no-go task) requiring suppression of inappropriate behavioural responses to "no-go" cues. Primary dependent measure is the percentage of correct trials and percentage of inhibitory failures
Measured: 14 days
Risky decision-making
Risky decision making will be assessed via a Balloon Analogue Risk Task involving pumping a hypothetical balloon with an unknown air capacity. Each pump results in greater points earned, but a popped balloon results in loss of all accumulated points. Primary dependent variable from this task is the total number of pumps and number of exploded balloons. Higher values for each variable reflect greater risk taking
Measured: 14 days
Interference control
Interference control will be assessed via the Erikson Flanker Task involving making a behavioural response to a central stimulus (left/right arrow) that is flanked by arrows that either point in same direction (congruent) or opposite direction (incongruent). Primary dependent variable is the percentage of correct trials in congruent vs incongruent conditions.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Why it stopped: Study stopped prior to initiation due to COVID-19 complications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Amlung, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252755
- Sponsor's protocol ID
- HIREB#8178
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain Processing Via Neurofeedback in Addictive Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT04252755
- Acronym / sponsor ID
- HIREB#8178
- Conditions
- Alcohol Drinking
- Keywords
- Electroencephalography (EEG), Neurofeedback, Alcohol Use, Cognition
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped prior to initiation due to COVID-19 complications
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Feb 2020 (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.
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.
Detailed description
The NFB studies conducted to date have utilized a wide range of methodologies and NFB training protocols. The outcome measures of NFB efficacy have also varied widely. As mentioned above, the studies also used expensive, non-portable equipment which may limit the application of NFB in treatment settings. This study seeks to address these limitations by using a commercially-available neurotechnology, the Muse™ headband by InteraXon (Toronto, ON, Canada) and using their standard NFB protocol built into the device application. This will maximize the standardization and portability of the NFB as essentially an "out of the box" intervention. The outcome measures will also capture multiple relevant domains, including clinical outcomes (e.g., drinking motivation) and neurocognitive performance (e.g., cognitive control / response inhibition).
The purpose of this study is to investigate the effects of NFB training on measures of cognitive control and alcohol motivation among young adults who engage in heavy episodic drinking (defined as exceeding 4+/5+ drinks per occasion for men/women).
The study will examine whether NFB reduces motivation/attention and craving for alcohol and attentional bias to alcohol-related cues. The primary outcome will be assessed by changes in the alcohol purchase task and approach/avoidance task, which participants will complete pre- and post-NFB training.
A secondary outcome is to determine whether NFB results in transfer of heightened fronto-cortical activity to improvements on general executive functioning following 8 sessions of NFB training. The secondary outcome will be assessed via changes in neurocognitive tasks assessing behavioural inhibition, risky decision making, and executive functioning, all of which will be administered pre- and post-NFB training.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EEG Neurofeedback | Other | Behavioral: EEG NeurofeedbackWithin-subjects sessions of EEG neurofeedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current undergraduate student, can be registered in the SONA research participant pool
- 18 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).
Key exclusion criteria (4 listed)
- 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.)
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 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. | Behavioural | EEG Neurofeedback |
Primary outcome
Alcohol motivation
Time frame: 14 days
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.
Alcohol approach/avoidance bias
Time frame: 14 days
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.
Alcohol craving
Time frame: 14 days
Subjective alcohol craving will be assessed via a visual analog scale (0-100, with 100 equal to maximum craving)
3 secondary outcomes
Behavioural inhibition
Time frame: 14 days
Risky decision-making
Time frame: 14 days
Interference control
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
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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. This study is not recruiting at the moment.
Michael Amlung, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG Neurofeedback in people with Alcohol Drinking, run by McMaster University at 1 site in Canada.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol motivation (time frame: 14 days). 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?
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 6 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.