Clinical trial NCT06865872: Alcohol and Sexual Communication Among Couples in the Laboratory
Official title: Alcohol and Sexual Communication Among Couples in the Laboratory
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Intoxication
Sexual Communication
Intimate Partner Violence (IPV)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-03-10
Enrollment: 480
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Intimate Partner Sexual Violence (IPSV) is a significant and understudied public health problem among sexual minority (SM) and heterosexual 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 (50% SM) 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 sexual 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 .08, 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, sexual communication, and (3) actor alcohol use will increase IPSV toward partners who are also drinking and use indirect, relative to direct, sexual communication.


Eligibility criteria: 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. Couples must either self-report that they are (1) different-sex couples in which both partners identify as cisgender and heterosexual, (2) same-sex couples in which both partners are cisgender men with a sexual minoritized identity (gay or bi/bi+), or (3) different-sex couples in which Partner A is a cisgender, heterosexual man and Partner B is a cisgender woman who identifies specifically as bi/bi+.
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.

Primary outcomes:
measure: Sexual Violence Perpetration as Measured by the Sexual Imposition Paradigm
timeFrame: up to 1 hour post beverage consumption
measure: Sexual Violence Perpetration Length of Time as Measured by the Sexual Imposition Paradigm
timeFrame: up to 1 hour post beverage consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References: