NCT06865872

Brief Summary

Intimate Partner Sexual Violence (IPSV) is a significant and understudied public health problem among couples, yet little is known about factors that contribute to IPSV perpetration. This proposal aims to determine the acute effect of alcohol and sexual communication on IPSV. In this study, 240 couples who drink alcohol will be recruited from the Metro-Denver area. Upon arrival to the laboratory, a trained research assistant will check the participant's ID, verify that they adhered to the pre-session guidelines, administer a breath test to ensure a breath alcohol content (BrAC) of 0.00 and conduct a field sobriety test. They will also obtain informed consent for each member of the couple separately. Female participants will take a pregnancy test to ensure a negative result. All participants will complete measures to reverify eligibility criteria and be weighed to determine their correct alcohol dose. Partners will separately complete a baseline survey measuring demographic factors, alcohol use, sexual communication, and daily experiences. After completing the survey, participants will be assigned a beverage condition (alcohol or no-alcohol control) and couples will be randomly assigned to a communication condition (direct verbal or indirect verbal). Participants will be seated in a room separate from their partner, where they will drink an alcoholic or no-alcohol control beverage. Upon reaching a breath alcohol content (BrAC) of .07, or immediately after drinking in the No-Alcohol control condition, participants will complete a laboratory assessment of sexual violence. The main hypotheses are: (1) one's alcohol use will increase IPSV toward partners who are also drinking, (2) one's alcohol use will increase IPSV among partners who use indirect, relative to direct, communication, and (3) actor alcohol use will increase IPSV toward partners who are also drinking and use indirect, relative to direct, communication.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Apr 2025Feb 2028

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 18, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

2.8 years

First QC Date

March 4, 2025

Last Update Submit

October 24, 2025

Conditions

Alcohol IntoxicationIntimate Partner Violence (IPV)Communication

Outcome Measures

Primary Outcomes (2)

  • Sexual Violence Perpetration as Measured by the Sexual Imposition Paradigm

    The Sexual Imposition Paradigm measures sexual violence perpetration. Possible scores are 0 (no perpetration) to 1 (perpetration).

    up to 1 hour post beverage consumption

  • Sexual Violence Perpetration Length of Time as Measured by the Sexual Imposition Paradigm

    The Sexual Imposition Paradigm measures sexual violence perpetration length of time. Scores range from 0 to 120 seconds, with higher scores indicating longer perpetration.

    up to 1 hour post beverage consumption

Study Arms (4)

Alcohol Consumption + Direct Communication

EXPERIMENTAL

Participants will be assigned to drink alcohol and to receive direct communication about their sexual preferences from their partner.

Other: Direct CommunicationDrug: Alcohol (Ethanol)

Alcohol Consumption + Indirect Communication

EXPERIMENTAL

Participants will be assigned to drink alcohol and to receive indirect communication about their sexual preferences from their partner.

Other: Indirect CommunicationDrug: Alcohol (Ethanol)

No Alcohol + Direct Communication

EXPERIMENTAL

Participants will be assigned to drink a no-alcohol control beverage and to receive direct communication about their sexual preferences from their partner.

Other: Direct CommunicationOther: No-Alcohol Control

No Alcohol + Indirect Communication

EXPERIMENTAL

Participants will be assigned to drink a no-alcohol control beverage and to receive indirect communication about their sexual preferences from their partner.

Other: Indirect CommunicationOther: No-Alcohol Control

Interventions

Direct CommunicationOTHER

Participants assigned to receive direct communication about their sexual preferences from their partner.

Alcohol Consumption + Direct CommunicationNo Alcohol + Direct Communication
Indirect CommunicationOTHER

Participants assigned to receive indirect communication about their sexual preferences from their partner.

Alcohol Consumption + Indirect CommunicationNo Alcohol + Indirect Communication
Alcohol (Ethanol)DRUG

Participants assigned to moderate alcohol dose condition (target BrAC .10%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures.

Alcohol Consumption + Direct CommunicationAlcohol Consumption + Indirect Communication
No-Alcohol ControlOTHER

Participants assigned to a no-alcohol control beverage.

No Alcohol + Direct CommunicationNo Alcohol + Indirect Communication

Eligibility Criteria

Age21 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth partners must identify as cisgender and at least one partner must identify as a man.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and lifestyle considerations.
  • Both partners must identify as cisgender via self-report on the Baseline Questionnaire.
  • At least one partner within the couple must be a man via self-report on the Baseline Questionnaire.
  • Both partners must be between 21 and 65 years old, verified by a photo ID.
  • In an intimate relationship lasting at least one month in which they engaged in sexual activity at least once in the past month with their partner via self-report on the Baseline Questionnaire.
  • Both partners must report that they consumed a weight-based amount of alcohol that is equal to or greater than the dose to be administered in the lab at least three times during the past year via self-report on question #5 of the NIAAA Alcohol Consumption Measure.

You may not qualify if:

  • Treatment for Alcohol or Drug Use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use via self-report.
  • Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration via self-report:
  • Cardiac Pacemaker
  • Asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year
  • Head Injury: any past serious head injuries
  • Acute Psychiatric Symptomatology: elevated psychological distress as indicated by a score greater than 65 on the Brief Symptom Inventory
  • Self-report that a participant is trying to get pregnant, currently pregnant, or currently breastfeeding or a positive pregnancy test.
  • Combined height and weight that is either less than 6 feet tall and over 230 lbs, or over 250 lbs and over 6 ft tall as measured during the lab visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Alcoholic IntoxicationCommunication

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Central Study Contacts

Ruschelle M Leone, PhD

CONTACT

303-724-7052ruschelle.leone@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

April 18, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

October 28, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

IPD will be available in the NIAAA Data Archive.

Locations

US(1)