Alcohol and Sexual Communication Among Couples in the Laboratory

October 24, 2025 updated by: University of Colorado, Denver
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Ruschelle M Leone, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and lifestyle considerations.
  3. Both partners must identify as cisgender via self-report on the Baseline Questionnaire.
  4. At least one partner within the couple must be a man via self-report on the Baseline Questionnaire.
  5. Both partners must be between 21 and 65 years old, verified by a photo ID.
  6. 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.
  7. 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.

Please contact clinical site for additional inclusion criteria.

Exclusion Criteria:

  1. 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.

  2. 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
  3. Self-report that a participant is trying to get pregnant, currently pregnant, or currently breastfeeding or a positive pregnancy test.
  4. 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.

Please contact clinical site for additional exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol Consumption + Direct Communication
Participants will be assigned to drink alcohol and to receive direct communication about their sexual preferences from their partner.
Drug: Alcohol (Ethanol)
Participants assigned to moderate alcohol dose condition (target BrAC .10%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures.
Other: Direct Communication
Participants assigned to receive direct communication about their sexual preferences from their partner.
Experimental: Alcohol Consumption + Indirect Communication
Participants will be assigned to drink alcohol and to receive indirect communication about their sexual preferences from their partner.
Drug: Alcohol (Ethanol)
Participants assigned to moderate alcohol dose condition (target BrAC .10%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures.
Other: Indirect Communication
Participants assigned to receive indirect communication about their sexual preferences from their partner.
Experimental: No Alcohol + Direct Communication
Participants will be assigned to drink a no-alcohol control beverage and to receive direct communication about their sexual preferences from their partner.
Other: No-Alcohol Control
Participants assigned to a no-alcohol control beverage.
Other: Direct Communication
Participants assigned to receive direct communication about their sexual preferences from their partner.
Experimental: No Alcohol + Indirect Communication
Participants will be assigned to drink a no-alcohol control beverage and to receive indirect communication about their sexual preferences from their partner.
Other: No-Alcohol Control
Participants assigned to a no-alcohol control beverage.
Other: Indirect Communication
Participants assigned to receive indirect communication about their sexual preferences from their partner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual Violence Perpetration as Measured by the Sexual Imposition Paradigm
Time Frame: up to 1 hour post beverage consumption
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
Time Frame: up to 1 hour post beverage consumption
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-1867
  • R01AA031666 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be available in the NIAAA Data Archive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Communication

Clinical Trials on No-Alcohol Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe