Alcohol & Men's Sexual Risk Behaviors

Alcohol Drinking Clinical Trial

Official title:

Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors (Extension)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158880
• Other study ID #: STUDY00018369
• Secondary ID: 4R37AA025212
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: Arizona State University
• Contact: Kelly Davis, PhD
• Phone: 6024963217
• Email: Kelly.Cue.Davis[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 30 Years

Eligibility

Inclusion Criteria:

• Single

• Male

• Ages 21-30

• Engagement in unprotected intercourse with a woman at least once in the past year

• Consumed alcohol at least 2 times per week in the past 30 days

• Had sex with a woman at least 2 times in the past 30 days

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aggression
• Alcohol Drinking
• Emotions
• Sexual Aggression
• Sexual Behavior

Intervention

Behavioral:
• Alcoholic Beverage
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.
• Non-alcoholic Beverage
Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
• Partner Negative Mood Manipulation
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
Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Georgia State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sexual risk behavior	Number of unprotected sexual intercourse events	6 months