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NCT Number: NCT06865872

Alcohol and Sexual Communication Among Couples in the Laboratory

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.

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Key information

Conditions

Alcohol Intoxication Alcohol-Related Disorders Alcoholic Intoxication Behavior Chemically-Induced Disorders Communication Intimate Partner Violence (IPV) Mental Disorders Substance-Related Disorders

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Ruschelle M Leone, PhD

CONTACT

[email protected]

303-724-7052

Ruschelle M Leone, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Please contact clinical site for additional inclusion criteria.

Exclusion criteria

  • 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.

Please contact clinical site for additional exclusion criteria.

Treatment and study plan

Direct Communication

Other

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

Indirect Communication

Other

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

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.

No-Alcohol Control

Other

Participants assigned to a no-alcohol control beverage.

Primary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruschelle M Leone, PhD

CONTACT

[email protected]

303-724-7052

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2025
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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