Clinical Trials Directory

Trials / Completed

CompletedNCT03037749

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

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
42 (actual)
Sponsor
University of New Mexico · Academic / Other
Sex
All
Age
21 Years – 45 Years
Healthy volunteers
Accepted

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.

Detailed description

Intimate partner violence (IPV) is a significant public health problem for which there are currently no effective treatments. Alcohol use is present in most instances of IPV and is associated with an increase in the frequency and severity of IPV. The investigators believe that alcohol may be related to the increase in frequency and severity of IPV through a process of over-arousal that results from the cortically and psychophysiological arousing effects of alcohol during the ascending limb of intoxication and at peak Blood Alcohol Concentration (BAC) compounded by the unique behavioral and affective patterns of violent couples. The first aim of the proposal is to determine if increases in arousal after alcohol exposure is potentiated by evocative partner stimuli and is greater for distressed violent (DV) partners than distressed nonviolent (DNV) partners. A second aim is to determine if alcohol induced arousal interferes with DV partners' ability to regulate emotion in response to evocative partner stimuli compared to DNV partners. The proposed study is an experimental comparison of the effects of alcohol on arousal and emotion regulation between 35 DV and 35 DNV partners. One partner from each DV couple will be pseudo-randomly selected and yoked to a DNV partner of the same sex and comparable relationship satisfaction for participant in the experiment. To test the overall hypothesis that over-arousal is a mechanism through which alcohol is associated with increases in the frequency and severity of IPV, the selected partners will participate in a counter-balanced placebo session and an alcohol administration session during which electroencephalography (EEG), psychophysiology and pupillary response measurements of arousal will be collected during an emotion regulation task. The data will be analyzed using a repeated measures ANOVA with a between-subjects factor. The investigators expect that DV partners will experience significantly greater arousal than DNV partners during the evocative stimuli condition. The investigators also expect that DV partners will experience greater difficulty regulating emotion during evocative stimuli than DNV partners and that this effect will be compounded during the alcohol administration condition. Findings from this study will provide firm evidence that alcohol is associated with IPV through a mechanism of over-arousal and provide key targets for intervention to prevent future IPV. The data from the current proposal will be used to test biofeedback as an adjunct to a novel behavioral intervention to reduce drinking and increase behavioral flexibility in couples with a history of IPV.

Conditions

Interventions

TypeNameDescription
DRUGAlcohol beverageAlcohol beverage measured to have participant achieve a BAC of 0.08%
DRUGPlacebo beveragePlacebo beverage measured to mimic the smell and taste of the alcohol beverage.

Timeline

Start date
2015-09-27
Primary completion
2018-08-31
Completion
2018-08-31
First posted
2017-01-31
Last updated
2024-10-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03037749. Inclusion in this directory is not an endorsement.