Alcohol's Impact on Men's Sexual Risk Behavior

Overseen By Nolan Eldridge

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Alcohol contraindications

Disqualifiers: Alcohol problems, Monogamous relationship, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have a medical condition or take medications that make alcohol consumption unsafe.

What data supports the effectiveness of the treatment Alcoholic Beverage, Non-alcoholic Beverage, Partner Negative Mood Manipulation, Partner Positive Mood Manipulation on men's sexual risk behavior?

Research shows that alcohol can increase sexual risk behaviors, especially when combined with sexual arousal and certain expectations about alcohol's effects. This suggests that alcohol consumption may influence men's decisions in risky sexual situations, which is relevant for understanding its impact on sexual risk behavior. ^{1 2 3 4 5}

Is alcohol generally safe for humans in clinical trials related to sexual behavior?

Research shows that alcohol can affect sexual behavior and risk, but it doesn't specifically address safety in terms of health risks. Alcohol is widely used and generally considered safe in moderate amounts, but excessive use can lead to health problems. ^{1 2 3 6 7}

How does the treatment involving alcohol and mood manipulation differ from other treatments for sexual risk behavior in men?

This treatment is unique because it combines the effects of alcohol consumption with mood manipulation to study their impact on men's sexual risk behavior, unlike other treatments that may focus solely on behavioral interventions or education. The research highlights how alcohol and mood can influence sexual decision-making, which is not typically addressed in standard treatments. ^{1 2 3 7 8}

Research Team

Kelly Davis, PhD

Principal Investigator

Arizona State University

Eligibility Criteria

This trial is for single men aged 21-30 who have had unprotected sex with a woman at least once in the past year, drink alcohol twice a week, and have been sexually active recently. Men with alcohol problems or medical issues that make drinking unsafe can't participate.

Inclusion Criteria

I have had sex with a woman at least twice in the last month.

I have had unprotected sex with a woman in the last year.

I have drunk alcohol at least twice a week in the last month.

Exclusion Criteria

In a relationship that is monogamous and has lasted longer than 6 months

I cannot drink alcohol due to my health condition or medications.

A history of alcohol problems

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Manipulation

Participants receive experimental manipulations involving mood and alcohol consumption to assess sexual risk behaviors

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for sexual risk behaviors over a period of time

6 months

Treatment Details

Interventions

• Alcoholic Beverage
• Non-alcoholic Beverage
• Partner Negative Mood Manipulation
• Partner Positive Mood Manipulation

Trial Overview The study looks at how alcohol affects sexual risk behaviors and aggression in men when interacting with women. It tests if men's emotions and their partner's mood influence these behaviors under the effects of both alcoholic and non-alcoholic beverages.

Participant Groups

Group I: Partner Negative Mood Manipulation Experimental Treatment 1 Intervention

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

Group II: Alcoholic beverage Experimental Treatment 1 Intervention

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

Group III: Partner Positive Mood Manipulation Active Control 1 Intervention

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

Group IV: Non-alcoholic beverage Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Georgia State University

Collaborator

Trials

71

Recruited

33,600+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The effects of alcohol and sexual arousal on determinants of sexual risk in men who have sex with men. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Alcohol and Sexual Health Behavior: "What We Know and How We Know It". [2020]

3. England pubmed.ncbi.nlm.nih.gov

Alcohol expectancies and male sexuality: review and implications for sex therapy. [2005]

4. United States pubmed.ncbi.nlm.nih.gov

Research on the Effects of Alcohol and Sexual Arousal on Sexual Risk in Men who have Sex with Men: Implications for HIV Prevention Interventions. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Protocol for a Controlled Experiment to Identify the Causal Role of Acute Alcohol Consumption in Condomless Sex among HIV-Positive MSM: Study Procedures, Ethical Considerations, and Implications for HIV Prevention. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Do Men Use More Sexually Aggressive Tactics When Intoxicated? A Within-Person Examination of Naturally Occurring Episodes of Sex. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Alcohol and sexual behaviour. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of alcohol, expectancies, and partner type on condom use in college males: event-level analyses. [2019]