An interventional study of Direct Communication and Indirect Communication in Alcohol Intoxication, Intimate Partner Violence (IPV) and Communication, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-28.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science
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.
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
This study's planned enrollment of 480 is above the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Please contact clinical site for additional inclusion criteria.
Exclusion Criteria:
Any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration via self-report:
Please contact clinical site for additional exclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be assigned to drink alcohol and to receive direct communication about their sexual preferences from their partner.
Other: Direct Communication · Drug: Alcohol (Ethanol)
Participants will be assigned to drink alcohol and to receive indirect communication about their sexual preferences from their partner.
Other: Indirect Communication · Drug: Alcohol (Ethanol)
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 Communication · Other: No-Alcohol Control
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 Communication · Other: No-Alcohol Control
Participants assigned to receive direct communication about their sexual preferences from their partner.
Participants assigned to receive indirect communication about their sexual preferences from their partner.
Participants assigned to moderate alcohol dose condition (target BrAC .10%) with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) approved alcohol administration procedures.
Participants assigned to a no-alcohol control beverage.
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).
Time frame: 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.
Time frame: up to 1 hour post beverage consumption
Plan to share: Yes — IPD will be available in the NIAAA Data Archive.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Feb 2028, 34 months after the start.
Of 29 interventional studies with no phase under Alcoholic Intoxication, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 58. This study's planned 34 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ethanol
University of Colorado, Denver →