Alcohol IntoxicationNCT06865872
Alcohol and Sexual Communication Among Couples in the Laboratory
A study testing Direct Communication, Indirect Communication and Alcohol (Ethanol) in people with Alcohol Intoxication and Intimate Partner Violence (IPV), run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intoxication, Intimate Partner Violence (IPV), Communication
- What is being tested?
- Direct Communication, Indirect Communication and Alcohol (Ethanol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Ruschelle M Leone, PhD, 303-724-7052, ruschelle.leone@cuanschutz.edu
Ruschelle M Leone, PhD
About this study
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.
- Being tested
- Direct Communication, Indirect Communication, Alcohol (Ethanol), No-Alcohol Control
- Medical subject headings
- Alcoholic Intoxication, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct CommunicationOther
Participants assigned to receive direct communication about their sexual preferences from their partner.
Indirect CommunicationOther
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 ControlOther
Participants assigned to a no-alcohol control beverage.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Consumption + Direct Communication | Experimental | Participants will be assigned to drink alcohol and to receive direct communication about their sexual preferences from their partner. Receives: Other: Direct Communication; Drug: 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. Receives: Other: Indirect Communication; Drug: 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. Receives: Other: Direct Communication; Other: 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. Receives: Other: Indirect Communication; Other: No-Alcohol Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: up to 1 hour post beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start18 Apr 2025
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol IntoxicationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865872
- Sponsor's protocol ID
- 24-1867
- Other IDs
- R01AA031666
- Status last verified
- Oct 2025
- First submitted
- 4 Mar 2025
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available in the NIAAA Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Sexual Communication Among Couples in the Laboratory
- ClinicalTrials.gov ID
- NCT06865872
- Acronym / sponsor ID
- 24-1867
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol Consumption + Direct Communication | Experimental | Other: Direct Communication, Drug: Alcohol (Ethanol)Participants will be assigned to drink alcohol and to receive direct communication about their sexual preferences from their partner. |
| Alcohol Consumption + Indirect Communication | Experimental | Other: Indirect Communication, Drug: Alcohol (Ethanol)Participants will be assigned to drink alcohol and to receive indirect communication about their sexual preferences from their partner. |
| No Alcohol + Direct Communication | Experimental | Other: Direct Communication, Other: No-Alcohol ControlParticipants will be assigned to drink a no-alcohol control beverage and to receive direct communication about their sexual preferences from their partner. |
| No Alcohol + Indirect Communication | Experimental | Other: Indirect Communication, Other: No-Alcohol ControlParticipants will be assigned to drink a no-alcohol control beverage and to receive indirect communication about their sexual preferences from their partner. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct CommunicationParticipants assigned to receive direct communication about their sexual preferences from their partner. | Other | Alcohol Consumption + Direct Communication, No Alcohol + Direct Communication |
| Indirect CommunicationParticipants assigned to receive indirect communication about their sexual preferences from their partner. | Other | Alcohol Consumption + Indirect Communication, No Alcohol + Indirect Communication |
| 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. | Drug | Alcohol Consumption + Direct Communication, Alcohol Consumption + Indirect Communication |
| No-Alcohol ControlParticipants assigned to a no-alcohol control beverage. | Other | No Alcohol + Direct Communication, No Alcohol + Indirect Communication |
Primary outcome
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Individual participant dataSharing planned: Yes. IPD will be available in the NIAAA Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Communication, Indirect Communication and Alcohol (Ethanol) in people with Alcohol Intoxication and Intimate Partner Violence (IPV), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruschelle M Leone, PhD (303-724-7052, ruschelle.leone@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Violence Perpetration as Measured by the Sexual Imposition Paradigm (time frame: up to 1 hour post beverage consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025.