ClinicalTrials.gg
RecruitingNCT06158880Updated Jul 17, 2026

Alcohol & Men's Sexual Risk Behaviors

An interventional study of Alcoholic Beverage and Non-alcoholic Beverage in Sexual Behavior, Alcohol Drinking and Sexual Aggression, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to male participants aged 21 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Arizona State University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
21 Years to 30 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Sexual Behavior
  • Alcohol Drinking
  • Sexual Aggression
  • Emotions

Keywords

  • Condom use resistance
  • Emotion dysregulation
03

In context

Sexual Behavior

224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.

This study's planned enrollment of 320 is above the median of 264 across 179 interventional studies indexed under Sexual Behavior.

Browse Sexual Behavior studies →

Lead sponsor

Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 1 time per week in the past 30 days
  • Had sex with a woman at least 2 times in the past 30 days

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
320 participants (estimated)

Study arms

  • Experimental
    Alcoholic beverage

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

    Behavioral: Alcoholic Beverage

  • Active comparator
    Non-alcoholic beverage

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

    Behavioral: Non-alcoholic Beverage

  • Experimental
    Partner Negative Mood Manipulation

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

    Behavioral: Partner Negative Mood Manipulation

  • Active comparator
    Partner Positive Mood Manipulation

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

    Behavioral: Partner Positive Mood Manipulation

Interventions

  • BehavioralAlcoholic 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.

  • BehavioralNon-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.

  • BehavioralPartner Negative Mood Manipulation

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

  • BehavioralPartner Positive Mood Manipulation

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

06

What researchers measure

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.

    Time frame: within one hour of receiving the intervention

Secondary outcomes

  1. Sexual risk behavior

    Number of unprotected sexual intercourse events

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — We will make available individual, de-identified participant data that underlie disseminated results.

Supporting information: Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 42 months after the start.

Of 106 non-industry interventional studies with no phase under Sexual Behavior, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 42 months is above that.

Counting every sponsor, half of 107 studies reached it within 23 months; a quarter within 11 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2023
First posted
Dec 6, 2023
StartActual
Jun 17, 2024
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Jul 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06158880
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Georgia State University
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Jun 17, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 17, 2026

Study contacts

Kelly Davis, PhD
Contact
Kelly.Cue.Davis@asu.edu
6024963217
Nolan Eldridge
Contact
neldrid2@asu.edu
Kelly Davis, PhD
principal investigator · Arizona State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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