Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

NCT05369169 | Completed

• 1 other identifier: Pro2021001073
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

Study Arms (2)

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)

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

Behavioral: Low demand cognitive task

Interventions

Resonance breathing BEHAVIORAL

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)

Resonance paced breathing

Low demand cognitive task BEHAVIORAL

Different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles

Low demand vanilla control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Participants will self-identify gender identity on an approved demographic questionnaire
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must report at least 2 binge drinking episodes in the past month
• Have normal or corrected-to-normal vision

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Binge Drinking; Alcohol Drinking; Respiratory Aspiration; Drinking Behavior

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Chair

Model Details: 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

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 11, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)