Alcohol & Men's Sexual Risk Behaviors

NCT06158880 | Recruiting

• 2 other identifiers: STUDY000183694R37AA025212
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

This project extends the investigators' previous research regarding the intersecting risks of alcohol, sexual risk behavior (SRB), and sexual aggression (SA) in male drinkers who have sex with women by examining the mediating and moderating roles of both intrapersonal and interpersonal emotional factors. While independent streams of research consistently document alcohol's role in SRB and SA, the investigators' work has demonstrated that these behaviors are related, and that alcohol exacerbates their likelihood both independently and synergistically. The researchers' investigations focus on a particular type of SRB: men's resistance to condom use with female partners who want to have protected sex. Condom use resistance (CUR) is common and normative among young male drinkers, with up to 80% of men reporting engaging in CUR. Of particular concern, research demonstrates that up to 42% of men report using coercive CUR tactics such as emotional manipulation, deception, condom sabotage, and force to obtain unprotected sex. Investigators will evaluate hypotheses that distal and proximal emotional and alcohol factors influence in-the-moment SRB/CUR intentions as well as daily alcohol use and SRB/CUR. The investigators will also examine whether the relationships among assessed variables are similar across experimental and naturalistic settings. That is, investigate the extent to which men's responses in the lab parallel their real-world drinking and SRB/CUR behaviors, particularly regarding self and partner emotions, empathy, and interpersonal stress.

Conditions

Sexual Behavior; Alcohol Drinking; Sexual Aggression; Emotions

Keywords

Condom use resistance; Emotion dysregulation

Outcome Measures

Primary Outcomes (1)

• Mean score of sexual risk intentions

  Self-reported ratings of unprotected sex likelihood in a hypothetical scenario Scale range: 1 (not at all likely) to 7 (very likely). A higher value is a worse outcome. This is one total scale (no subscales). Items are averaged to compute a mean score.

  within one hour of receiving the intervention

Secondary Outcomes (1)

• Sexual risk behavior

  6 months

Study Arms (4)

Alcoholic beverage

EXPERIMENTAL

Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%.

Behavioral: Alcoholic Beverage

Non-alcoholic beverage

ACTIVE COMPARATOR

Participants will receive a beverage that does not contain alcohol (fruit juice only).

Behavioral: Non-alcoholic Beverage

Partner Negative Mood Manipulation

EXPERIMENTAL

Participants receive an experimental manipulation describing negative emotions in a hypothetical sexual partner.

Behavioral: Partner Negative Mood Manipulation

Partner Positive Mood Manipulation

ACTIVE COMPARATOR

Participants receive an experimental manipulation describing positive emotions in a hypothetical sexual partner.

Behavioral: Partner Positive Mood Manipulation

Interventions

Alcoholic Beverage BEHAVIORAL

Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight.

Alcoholic beverage

Non-alcoholic Beverage BEHAVIORAL

Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.

Non-alcoholic beverage

Partner Negative Mood Manipulation BEHAVIORAL

Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.

Partner Negative Mood Manipulation

Partner Positive Mood Manipulation BEHAVIORAL

Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.

Partner Positive Mood Manipulation

Eligibility Criteria

• Age: 21 Years - 30 Years
• Gender Eligibility Details: Self-defined as male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Single
• Male
• Ages 21-30
• Engagement in unprotected intercourse with a woman at least once in the past year
• Consumed alcohol at least 1 time per week in the past 30 days
• Had sex with a woman at least 2 times in the past 30 days

You may not qualify if:

• A history of alcohol problems
• A medical condition and/or medications which contraindicate alcohol consumption
• In a relationship that is monogamous and has lasted longer than 6 months

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Georgia State University: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Sexual Behavior; Alcohol Drinking

Interventions

Alcoholic Beverages

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kelly Davis, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Davis, PhD

CONTACT

6024963217; Kelly.Cue.Davis@asu.edu

Nolan Eldridge

CONTACT

neldrid2@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: June 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Immediately following publication and ending 3 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal for the use of the data. Data will also be made available through the NIAAA Data Archive.

Locations

US (1)