Alcohol and Sexual Communication Among Couples in the Laboratory

NCT ID: NCT06865872

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2028-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Intoxication Intimate Partner Violence (IPV) Communication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alcohol Consumption + Direct Communication

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

Group Type EXPERIMENTAL

Direct Communication

Intervention Type OTHER

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

Alcohol (Ethanol)

Intervention Type 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 + Indirect Communication

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

Group Type EXPERIMENTAL

Indirect Communication

Intervention Type OTHER

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

Alcohol (Ethanol)

Intervention Type 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 + 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.

Group Type EXPERIMENTAL

Direct Communication

Intervention Type OTHER

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

No-Alcohol Control

Intervention Type OTHER

Participants assigned to a no-alcohol control beverage.

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.

Group Type EXPERIMENTAL

Indirect Communication

Intervention Type OTHER

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

No-Alcohol Control

Intervention Type OTHER

Participants assigned to a no-alcohol control beverage.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Direct Communication

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

Intervention Type OTHER

Indirect Communication

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

Intervention Type OTHER

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.

Intervention Type DRUG

No-Alcohol Control

Participants assigned to a no-alcohol control beverage.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ruschelle M Leone, PhD

Role: CONTACT

303-724-7052

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ruschelle M Leone, PhD

Role: primary

303-724-7052

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AA031666

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1867

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Intervention Following Sexual Assault
NCT04582695 ACTIVE_NOT_RECRUITING NA
Alcohol Use and Relationships - III
NCT01753986 UNKNOWN PHASE2