Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

NCT ID: NCT05369169

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Binge Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Resonance breathing

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Low demand cognitive task

Intervention Type BEHAVIORAL

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

Interventions

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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)

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Brandon Alderman, Ph.D.

Associate Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon L Alderman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Marsha E Bates, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Rutgers, The State University of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ian R Frazier, Ph.D.

Role: CONTACT

352-284-7304

Andrew A Ude, B.A.

Role: CONTACT

631-295-6649

Facility Contacts

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Brandon Alderman, PhD

Role: primary

848-445-9336

Marsha Bates, PhD

Role: backup

Other Identifiers

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Pro2021001073

Identifier Type: -

Identifier Source: org_study_id

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