NCT03956238

Brief Summary

The present project integrates previous research on factors associated with alcohol-involved sexual assault, with research on how intoxication alters attention and social perceptions in ways that increase the risk of sexual aggression and victimization. Specifically, this project examines whether alcohol intoxication on the part of a male perpetrator impairs attentional capacity and leads to a narrowing of the perceptual field causing a dehumanizing perspective of women as sexual objects for men's pleasure rather than individuals with thoughts and feelings, thereby increasing the propensity for sexual aggression. The present research also examines whether women's responses to this sexual objectification from men interfere with risk perception in sexual situations, particularly when women are drinking, increasing the likelihood of sexual victimization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
359

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

3.7 years

First QC Date

May 2, 2019

Last Update Submit

July 6, 2023

Conditions

Keywords

Alcohol intoxicationAlcohol useDrinkingSexual assaultSexual violenceAggressionAttentionVictimizationPublic health

Outcome Measures

Primary Outcomes (2)

  • Laboratory analogue of sexual aggression

    After learning that a woman does not like sexual media, male participants choose to show her a sexually explicit video or control video (selection of the sexually explicit video indicates more sexual aggression)

    20 minutes post alcohol or placebo dosing

  • Sexual assault vignette measure of risk perception

    Female participants read 18 vignettes describing a sexual interaction between a man and a woman that gets progressively riskier for sexual assault and indicate when they would leave the interaction (scores range from 1-18 and higher scores indicate worse risk perception)

    20 minutes post alcohol or placebo dosing

Secondary Outcomes (8)

  • Eye-tracking measure of sexual objectification

    2 minutes post alcohol or placebo dosing

  • Eye-tracking measure of self-objectification

    2 minutes post alcohol or placebo dosing

  • Object brief-implicit association task

    25 minutes post alcohol or placebo dosing

  • Self-object brief-implicit association task

    25 minutes post alcohol or placebo dosing

  • Self-report state mindful attention awareness scale

    30 minutes post alcohol or placebo dosing

  • +3 more secondary outcomes

Study Arms (6)

Males and Alcohol Intoxication

EXPERIMENTAL

Men assigned to alcohol intoxication arm (target BAC .08%)

Behavioral: Alcohol intoxication

Males and Placebo Control

PLACEBO COMPARATOR

Men assigned to placebo control arm

Behavioral: Alcohol intoxication

Females and Alcohol Intoxication and Objectifying Gazes

EXPERIMENTAL

Women assigned to alcohol intoxication arm (target BAC .08%) and objectifying gazes arm

Behavioral: Alcohol intoxicationBehavioral: Objectification

Females and Alcohol Intoxication and Eye Gazes

EXPERIMENTAL

Women assigned to alcohol intoxication arm (target BAC .08%) and eye gazes arm

Behavioral: Alcohol intoxicationBehavioral: Objectification

Females and Placebo Control and Objectifying Gazes

EXPERIMENTAL

Women assigned to placebo control arm and objectifying gazes arm

Behavioral: Alcohol intoxicationBehavioral: Objectification

Females and Placebo Control and Eye Gazes

PLACEBO COMPARATOR

Women assigned to placebo control arm and eye gazes arm

Behavioral: Alcohol intoxicationBehavioral: Objectification

Interventions

Men and women assigned to moderate alcohol dose condition (target BAC .08%) or placebo control condition with NIAAA approved alcohol administration procedures

Females and Alcohol Intoxication and Eye GazesFemales and Alcohol Intoxication and Objectifying GazesFemales and Placebo Control and Eye GazesFemales and Placebo Control and Objectifying GazesMales and Alcohol IntoxicationMales and Placebo Control
ObjectificationBEHAVIORAL

Women assigned to objectifying gazes condition or eye contact control condition

Females and Alcohol Intoxication and Eye GazesFemales and Alcohol Intoxication and Objectifying GazesFemales and Placebo Control and Eye GazesFemales and Placebo Control and Objectifying Gazes

Eligibility Criteria

Age21 Years - 30 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants who self-identify as men will participate in Study 1 and participants who self-identify as women will participant in Study 2
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • at least social drinkers
  • single
  • men attracted to women, women attracted to men

You may not qualify if:

  • current/past alcohol dependence (as assessed by a score of 8 or higher on the Alcohol Dependence Scale), alcohol-related treatment, or hospitalization due to alcohol use
  • any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
  • serious psychological symptoms (defined as past psychotic, paranoid, or bipolar disorders, or current major depression)
  • abstinence from alcohol use
  • a condition or medication use in which alcohol consumption is medically contraindicated
  • any legal restriction against drinking (e.g., as condition of probation or parole)
  • presence of a positive breath alcohol concentration (BAC) upon arrival to the laboratory
  • if the participant is less than six feet tall and weighs over 250 pounds or is over six feet tall and weighs over 300 pounds
  • if a female participant is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

Location

MeSH Terms

Conditions

Alcoholic IntoxicationAlcohol DrinkingAggression

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehaviorAberrant Motor Behavior in DementiaBehavioral SymptomsSocial Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Sarah Gervais, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 20, 2019

Study Start

April 22, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data may be shared with other researchers (e.g., posted to the Open Science Framework) to aid with reproducibility and replicability of science.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
De-identified data may be made available to interested researchers when papers based on that data are published in scientific journals.
Access Criteria
Interested researchers will be required to have an Open Science Framework account.

Locations