Binge DrinkingNCT05369169
Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control
A study testing Resonance breathing and Low demand cognitive task in people with Binge Drinking, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Conscious attempts to regulate alcohol use are often undermined by automatic attention and arousal processes activated by alcohol cues, as well as by diminished ability to inhibit in-the-moment behaviors. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking
- What is being tested?
- Resonance breathing and Low demand cognitive task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2024
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must report at least 2 binge drinking episodes in the past month
- Have normal or corrected-to-normal vision
Who cannot join
- History or presence of serious psychiatric disorders, neurological disorders, or head injury resulting in a loss of consciousness
- Presence of any serious medical condition
- Report of more than a few occasions (3-4) of illicit drug use, except for cannabis, in the preceding year
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901
About this study
Conscious attempts to regulate alcohol use are often undermined by automatic attention and arousal processes activated by alcohol cues, as well as by diminished ability to inhibit in-the-moment behaviors. The current study will examine whether a brief behavioral intervention of slow breathing paced at a resonance frequency of the cardiovascular system can interrupt automatic alcohol cue reactivity and enhance cognitive control in binge drinkers. Results from the proposed study may provide new prevention and intervention targets to interrupt unhealthy drinking behaviors.
- Conditions
- Binge Drinking
- Being tested
- Resonance breathing, Low demand cognitive task
- Keywords
- Alcohol Consumption, Baroreflex, Arousal, Breathing, Cardiovascular System, Cognition, Electrophysiology, Event-Related Potentials, Heavy Drinking, Attention, Individual Differences, Alcohol Cue, Brief Intervention, Cognitive Control, Cue Reactivity, Drinking Behavior, Young Adult, Heart Rate Variability
- Medical subject headings
- Binge Drinking, Alcohol Drinking, Respiratory Aspiration, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance breathingBehavioural
Participants will synchronize their breathing with a visual pacer (E-Z Air, Thought Technology, Ltd., Plattsburgh, NY) that moves up (inhale) and down (exhale) at the rate of 0.1 Hz (6 breaths per min)
Low demand cognitive taskBehavioural
Different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles
| Study group | Role | What they receive |
|---|---|---|
| Resonance paced breathing | Experimental | Active resonance breathing task consisting of synchronizing breathing with a visual pacer (E-Z Air, Thought Technology, Ltd., Plattsburgh, NY) that moves up (inhale) and down (exhale) at the rate of 0.1 Hz (6 breaths per min) Receives: Behavioral: Resonance breathing |
| Low demand vanilla control | Active comparator | A low-demand cognitive "vanilla" task wherein different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles Receives: Behavioral: Low demand cognitive task |
What is being measured
The primary outcome is the main question the study is designed to answer.
N2 ERP amplitude (in microvolts) elicited from an Alcohol Cued Go/No-Go task
The N2 component (in microvolts) of the event-related potential occurring 250-350 ms after stimulus presentation at frontal and central electrode sites during an Alcohol Cued Go/No-Go task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
N2pc ERP amplitude (in microvolts) elicited from a visual dot probe detection task
The N2pc component of the event-related potential occurring 200-275 ms after stimulus presentation at parietal and occipital electrode sites (ipsilateral minus contralateral hemisphere activity) during a modified visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
P3b ERP amplitude (in microvolts) elicited from a picture-viewing task
The P3b component of the event-related potential occurring 300-600 ms after stimulus presentation at central and parietal electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
N2 ERP latency (in milliseconds) elicited from an Alcohol Cued Go/No-Go task
The latency of the N2 component of the event-related potential from frontal and central electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
N2pc ERP latency (in milliseconds) elicited from a visual dot probe detection task
The latency of the N2pc component of the event-related potential from parietal and occipital electrode sites during a visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
P3b ERP latency (in milliseconds) elicited from a picture-viewing task
The latency of the P3b component of the event-related potential from central and parietal electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Task accuracy from the behavioral response during the Alcohol Cued Go/No-Go task
Task accuracy as a percentage of correct behavioral responses to the task during the Alcohol Cued Go/No-Go ERP task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Reaction time from the behavioral response during the Alcohol Cued Go/No-Go task
Reaction time for the correct behavioral responses to the task measured in milliseconds during the Alcohol Cued Go/No-Go ERP task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Task accuracy from the behavioral response during the visual dot probe detection task
Task accuracy as a percentage of correct behavioral responses to the task during the visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Reaction time from the behavioral response during the visual dot probe detection task
Reaction time for the correct behavioral responses to the task measured in milliseconds during the visual dot probe ERP task following a 5-minute course of resonance breathing compared to a low-demand control task
Measured: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will complete an active treatment of slow resonance paced breathing and a control visual color block task on separate days, separated by approximately one week
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Alderman, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Brandon L Alderman, Ph.D., Principal investigator, Rutgers, The State University of New JerseyMarsha E Bates, Ph.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369169
- Sponsor's protocol ID
- Pro2021001073
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share data via the NIAAA Data Archive (NIAAADA) repository within the larger National Institute of Mental Health (NIMH) Data Archive (NDA). Data generated by the proposed project include the following information on participants (male and female) aged 18-35 years: Surveys: * Basic Demographics (Age, Sex, Race/Ethnicity, Height/Weight) * Current Alcohol and Substance Use * Alcohol Use Questionnaire (AUQ), Penn Alcohol Craving Scale (PACS), and Alcohol Sensitivity Questionnaire Electrophysiological Data: * N2pc, P3b, and N2 components of the human event-related brain potential (ERP) * Collected during three cognitive tasks of cue reactivity (2) and inhibitory control (1)
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control
- ClinicalTrials.gov ID
- NCT05369169
- Acronym / sponsor ID
- Pro2021001073
- Conditions
- Binge Drinking
- Keywords
- Alcohol Consumption, Baroreflex, Arousal, Breathing, Cardiovascular System, Cognition, Electrophysiology, Event-Related Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 May 2022 (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.
Conscious attempts to regulate alcohol use are often undermined by automatic attention and arousal processes activated by alcohol cues, as well as by diminished ability to inhibit in-the-moment behaviors. The current study will examine whether a brief behavioral intervention of slow breathing paced at a resonance frequency of the cardiovascular system can interrupt automatic alcohol cue reactivity and enhance cognitive control in binge drinkers. Results from the proposed study may provide new prevention and intervention targets to interrupt unhealthy drinking behaviors.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will complete an active treatment of slow resonance paced breathing and a control visual color block task on separate days, separated by approximately one week
| Arm | Type | Receives |
|---|---|---|
| Resonance paced breathing | Experimental | Behavioral: Resonance breathingActive resonance breathing task consisting of synchronizing breathing with a visual pacer (E-Z Air, Thought Technology, Ltd., Plattsburgh, NY) that moves up (inhale) and down (exhale) at the rate of 0.1 Hz (6 breaths per min) |
| Low demand vanilla control | Active comparator | Behavioral: Low demand cognitive taskA low-demand cognitive "vanilla" task wherein different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must report at least 2 binge drinking episodes in the past month
- Have normal or corrected-to-normal vision
Key exclusion criteria (3 listed)
- History or presence of serious psychiatric disorders, neurological disorders, or head injury resulting in a loss of consciousness
- Presence of any serious medical condition
- Report of more than a few occasions (3-4) of illicit drug use, except for cannabis, in the preceding year
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 |
|---|---|---|
| Resonance breathingParticipants will synchronize their breathing with a visual pacer (E-Z Air, Thought Technology, Ltd., Plattsburgh, NY) that moves up (inhale) and down (exhale) at the rate of 0.1 Hz (6 breaths per min) | Behavioural | Resonance paced breathing |
| Low demand cognitive taskDifferent colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles | Behavioural | Low demand vanilla control |
Primary outcome
N2 ERP amplitude (in microvolts) elicited from an Alcohol Cued Go/No-Go task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
The N2 component (in microvolts) of the event-related potential occurring 250-350 ms after stimulus presentation at frontal and central electrode sites during an Alcohol Cued Go/No-Go task following a 5-minute course of resonance breathing compared to a low-demand control task
N2pc ERP amplitude (in microvolts) elicited from a visual dot probe detection task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
The N2pc component of the event-related potential occurring 200-275 ms after stimulus presentation at parietal and occipital electrode sites (ipsilateral minus contralateral hemisphere activity) during a modified visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task
P3b ERP amplitude (in microvolts) elicited from a picture-viewing task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
The P3b component of the event-related potential occurring 300-600 ms after stimulus presentation at central and parietal electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task
N2 ERP latency (in milliseconds) elicited from an Alcohol Cued Go/No-Go task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
The latency of the N2 component of the event-related potential from frontal and central electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions
N2pc ERP latency (in milliseconds) elicited from a visual dot probe detection task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
The latency of the N2pc component of the event-related potential from parietal and occipital electrode sites during a visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions
P3b ERP latency (in milliseconds) elicited from a picture-viewing task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
The latency of the P3b component of the event-related potential from central and parietal electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions
Task accuracy from the behavioral response during the Alcohol Cued Go/No-Go task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Task accuracy as a percentage of correct behavioral responses to the task during the Alcohol Cued Go/No-Go ERP task following a 5-minute course of resonance breathing compared to a low-demand control task
Reaction time from the behavioral response during the Alcohol Cued Go/No-Go task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Reaction time for the correct behavioral responses to the task measured in milliseconds during the Alcohol Cued Go/No-Go ERP task following a 5-minute course of resonance breathing compared to a low-demand control task
Task accuracy from the behavioral response during the visual dot probe detection task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Task accuracy as a percentage of correct behavioral responses to the task during the visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task
Reaction time from the behavioral response during the visual dot probe detection task
Time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
Reaction time for the correct behavioral responses to the task measured in milliseconds during the visual dot probe ERP task following a 5-minute course of resonance breathing compared to a low-demand control task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. We plan to share data via the NIAAA Data Archive (NIAAADA) repository within the larger National Institute of Mental Health (NIMH) Data Archive (NDA). Data generated by the proposed project include the following information on participants (male and female) aged 18-35 years: Surveys: * Basic Demographics (Age, Sex, Race/Ethnicity, Height/Weight) * Current Alcohol and Substance Use * Alcohol Use Questionnaire (AUQ), Penn Alcohol Craving Scale (PACS), and Alcohol Sensitivity Questionnaire Electrophysiological Data: * N2pc, P3b, and N2 components of the human event-related brain potential (ERP) * Collected during three cognitive tasks of cue reactivity (2) and inhibitory control (1)
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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.
Brandon L Alderman, Ph.D. principal investigator
Rutgers, The State University of New Jersey
Marsha E Bates, Ph.D. principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonance breathing and Low demand cognitive task in people with Binge Drinking, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 20 Apr 2026. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
N2 ERP amplitude (in microvolts) elicited from an Alcohol Cued Go/No-Go task (time frame: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart). The study lists 10 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 20 Apr 2026.