Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence

NCT03037749 | Completed Early Phase 1

• 1 other identifier: 12-433
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per year with over $6 billion in direct medical and mental health costs alone. Alcohol is present in most incidents of IPV, and contributes to more frequent and severe IPV incidents. These facts, coupled with the fact that there are no effective interventions for IPV, make understanding mechanisms through which alcohol is associated with IPV critical.

Conditions

Domestic Violence; Alcohol Consumption

Outcome Measures

Primary Outcomes (6)

• neurophysiological arousal collected via electroencephalography

  electroencephalography. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses. Greater alpha and beta frequencies relative to reduced to theta and delta frequencies indicate greater cortical arousal. The experimental conditions of this study will allow us to determine if distressed violent partners experience greater cortical arousal in certain conditions.

  two years

• neurophysiological arousal collected via electrocardiogram

  respiratory sinus arrythymia. This is a measure of heart rate variability that is an index of a person's ability to regulate their emotion. The responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.

  two years

• neurophysiological arousal collected via galvanic skin response

  galvanic skin response. When people are neurophysiologically aroused, their skin sweats more. This responses on this measures these changes between conditions and groups, and are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.

  two years

• neurophysiological response collected via respiration

  respiration. When neurophysiologically aroused people breathe faster. This responses on this measure will are evaluated against the comparison group to determine if the distressed violent group is more neurophysiologically aroused in certain experimental conditions. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.

  two years

• neurophysiological response collected via eye tracking

  pupillary response. When people are neurophysiologically aroused their pupils dilate. This responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.

  two years

• emotion regulation

  This is an experimental task that all participants in both the distressed violent group and the distressed nonviolent group complete. In the emotion regulation task, an comparison of the aggregated primary outcome measures will be compared between groups to determine if distressed violent participants experience greater neurophysiological arousal than distressed nonviolent participants.

  two years

Study Arms (2)

Distressed violent

EXPERIMENTAL

Distressed violent partners participated in a within-subjects placebo-controlled alcohol administration arm with an emotion-regulation task.

Drug: Alcohol beverage; Drug: Placebo beverage

Distressed nonviolent

EXPERIMENTAL

Distressed nonviolent partners participated in a within-subjects placebo-controlled alcohol administration arm with an emotion-regulation task.

Drug: Alcohol beverage; Drug: Placebo beverage

Interventions

Alcohol beverage DRUG

Alcohol beverage measured to have participant achieve a BAC of 0.08%

Distressed nonviolent; Distressed violent

Placebo beverage DRUG

Placebo beverage measured to mimic the smell and taste of the alcohol beverage.

Distressed nonviolent; Distressed violent

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English-speaking
• Heterosexual,
• Be in a distressed relationship
• consume at least one to two alcoholic drinks per sitting each week for females and three to four alcoholic drinks for males
• report two binge drinking episodes (\>4 drinks for males, \>3 drinks for females) in month prior to assessment
• be married or cohabitating for at least six months
• both partners must be willing to participate
• must have a breath alcohol level of 0.0 g% at all visits.
• Distressed Violent couples must have a history of at least mild physical aggression in the past six months (e.g.,twisted partner's arm or hair).

You may not qualify if:

• currently separated
• an order of protection in place
• facing violence-related criminal charges
• currently in a domestic violence shelter
• evidence of psychosis or severe personality disturbance
• pregnant
• taking a medication contraindicated for use with alcohol
• currently taking insulin or oral hypoglycemic medication,
• an AUDIT score greater than 19 indicating dependent drinking
• illicit drug use (except marijuana)
• provide a positive urinalysis at first emotion-regulation session

Sponsors & Collaborators

• University of New Mexico: lead
• The Mind Research Network: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Brandi C Fink, Ph.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Eric D. Claus, Ph.D.

  The Mind Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both distressed violent and distressed nonviolent partners participated in two experimental sessions and were counter-balanced to receive either an alcohol beverage or a placebo beverage in the first or second experimental session.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a within subjects design where distressed violent and distressed nonviolent partners participated in a placebo-controlled alcohol administration study with an emotion-regulation task.

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: January 31, 2017
• Study Start: September 27, 2015
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)