Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resonance breathing

Low demand cognitive task

About this trial

This is an interventional basic science trial for Binge Drinking focused on measuring 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

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rutgers, The State University of New JerseyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resonance paced breathing

Low demand vanilla control

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05369169

First Posted

March 16, 2022

Last Updated

July 15, 2022

Sponsor

Rutgers, The State University of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT05369169

Brief Title

Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

Official Title

Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resonance paced breathing

Arm Type

Experimental

Arm Description

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)

Arm Title

Low demand vanilla control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Resonance breathing

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Low demand cognitive task

Intervention Description

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

Primary Outcome Measure Information:

Title

N2 ERP amplitude (in microvolts) elicited from an Alcohol Cued Go/No-Go task

Description

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

Time Frame