- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05369169
Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control
April 15, 2026 updated by: Brandon Alderman, Ph.D., Rutgers, The State University of New Jersey
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Rutgers, The State University of New Jersey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must report at least 2 binge drinking episodes in the past month
- Have normal or corrected-to-normal vision
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resonance paced breathing
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)
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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)
|
|
Active Comparator: Low demand vanilla control
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
|
Different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
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
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
|
Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brandon L Alderman, Ph.D., Rutgers, The State University of New Jersey
- Principal Investigator: Marsha E Bates, Ph.D., Rutgers, The State University of New Jersey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
March 16, 2022
First Submitted That Met QC Criteria
May 5, 2022
First Posted (Actual)
May 11, 2022
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2021001073
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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)
IPD Sharing Time Frame
At the conclusion of data collection and no later than 24 months after the NIH award end date or 6 months post-publication of the final data set (whichever date occurs first).
There is no restriction for how long the data will be available.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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