Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

Binge Drinking Clinical Trial

Official title:

Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369169
• Other study ID #: Pro2021001073
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: July 2022
• Source: Rutgers, The State University of New Jersey
• Contact: Ian R Frazier, Ph.D.
• Phone: 352-284-7304
• Email: irf9[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Drinking

Intervention

Behavioral:
• Resonance breathing
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 task
Different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles

Locations

Country	Name	City	State
United States	Rutgers, The State University of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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