Domestic ViolenceEarly Phase 1NCT03037749
Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
A Early Phase 1 study testing Alcohol beverage in people with Domestic Violence and Alcohol Consumption, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Alcohol Consumption
- What is being tested?
- Alcohol beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2015to 31 Aug 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
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.
Read the 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
- Domestic Violence, Alcohol Consumption
- Being tested
- Alcohol beverage, Placebo beverage
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol beverageDrug
Alcohol beverage measured to have participant achieve a BAC of 0.08%
Placebo beverageDrug
Placebo beverage measured to mimic the smell and taste of the alcohol beverage.
| Study group | Role | What they receive |
|---|---|---|
| Distressed violent | Experimental | Distressed violent partners participated in a within-subjects placebo-controlled alcohol administration arm with an emotion-regulation task. Receives: 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. Receives: Drug: Alcohol beverage; Drug: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start27 Sep 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- The Mind Research Network
- Responsible party
- Principal investigator, Brandi C. Fink, PhD, University of New Mexico
- Investigators
- Brandi C Fink, Ph.D., Principal investigator, University of OklahomaEric D. Claus, Ph.D., Principal investigator, The Mind Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037749
- Sponsor's protocol ID
- 12-433
- Status last verified
- Oct 2024
- First submitted
- 19 Apr 2016
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT03037749
- Acronym / sponsor ID
- 12-433
- Conditions
- Domestic Violence, Alcohol Consumption
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- The Mind Research Network
- Study start
- 27 Sep 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Distressed violent | Experimental | Drug: Alcohol beverage, Drug: Placebo beverageDistressed violent partners participated in a within-subjects placebo-controlled alcohol administration arm with an emotion-regulation task. |
| Distressed nonviolent | Experimental | Drug: Alcohol beverage, Drug: Placebo beverageDistressed nonviolent partners participated in a within-subjects placebo-controlled alcohol administration arm with an emotion-regulation task. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol beverageAlcohol beverage measured to have participant achieve a BAC of 0.08% | Drug | Distressed nonviolent, Distressed violent |
| Placebo beveragePlacebo beverage measured to mimic the smell and taste of the alcohol beverage. | Drug | Distressed nonviolent, Distressed violent |
Primary outcome
neurophysiological arousal collected via electroencephalography
Time frame: two years
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.
neurophysiological arousal collected via electrocardiogram
Time frame: two years
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.
neurophysiological arousal collected via galvanic skin response
Time frame: two years
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.
neurophysiological response collected via respiration
Time frame: two years
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.
neurophysiological response collected via eye tracking
Time frame: two years
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.
emotion regulation
Time frame: two years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandi C Fink, Ph.D. principal investigator
University of Oklahoma
Eric D. Claus, Ph.D. principal investigator
The Mind Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol beverage in people with Domestic Violence and Alcohol Consumption, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurophysiological arousal collected via electroencephalography (time frame: two years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.