Sexual BehaviorNCT06158880
Alcohol & Men's Sexual Risk Behaviors
A study testing Alcoholic Beverage, Non-alcoholic Beverage and Partner Negative Mood Manipulation in people with Sexual Behavior and Alcohol Drinking, run by Arizona State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men only
- Conditions the study is for
- Sexual Behavior, Alcohol Drinking, Sexual Aggression
- What is being tested?
- Alcoholic Beverage, Non-alcoholic Beverage and Partner Negative Mood Manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nolan Eldridge contact
United States1 site, 1 recruiting
- Recruiting
Arizona State University
Phoenix, Arizona, 85004
Kelly Davis, PhD, 602-496-3217, kelly.cue.davis@asu.edu
Nolan Eldridge, neldrid2@asu.edu
About this study
Official title: Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors (Extension)
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
- Being tested
- Alcoholic Beverage, Non-alcoholic Beverage, Partner Negative Mood Manipulation, Partner Positive Mood Manipulation
- Keywords
- Condom use resistance, Emotion dysregulation
- Medical subject headings
- Sexual Behavior, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcoholic BeverageBehavioural
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 BeverageBehavioural
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 ManipulationBehavioural
Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.
Partner Positive Mood ManipulationBehavioural
Participants will engage in a laboratory task and will then report their own and their partner's emotions following the task.
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic beverage | Experimental | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Receives: Behavioral: Alcoholic Beverage |
| Non-alcoholic beverage | Active comparator | Participants will receive a beverage that does not contain alcohol (fruit juice only). Receives: Behavioral: Non-alcoholic Beverage |
| Partner Negative Mood Manipulation | Experimental | Participants receive an experimental manipulation describing negative emotions in a hypothetical sexual partner. Receives: Behavioral: Partner Negative Mood Manipulation |
| Partner Positive Mood Manipulation | Active comparator | Participants receive an experimental manipulation describing positive emotions in a hypothetical sexual partner. Receives: Behavioral: Partner Positive Mood Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one hour of receiving the intervention
Secondary outcomes (1)
Sexual risk behavior
Number of unprotected sexual intercourse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start17 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Georgia State University
- Responsible party
- Sponsor
- Investigators
- Kelly Davis, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158880
- Sponsor's protocol ID
- STUDY00018369
- Other IDs
- 4R37AA025212
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make available individual, de-identified participant data that underlie disseminated results.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors (Extension)
- ClinicalTrials.gov ID
- NCT06158880
- Acronym / sponsor ID
- STUDY00018369
- Conditions
- Sexual Behavior, Alcohol Drinking, Sexual Aggression, Emotions
- Keywords
- Condom use resistance, Emotion dysregulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Georgia State University
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcoholic beverage | Experimental | Behavioral: Alcoholic BeverageParticipants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. |
| Non-alcoholic beverage | Active comparator | Behavioral: Non-alcoholic BeverageParticipants will receive a beverage that does not contain alcohol (fruit juice only). |
| Partner Negative Mood Manipulation | Experimental | Behavioral: Partner Negative Mood ManipulationParticipants receive an experimental manipulation describing negative emotions in a hypothetical sexual partner. |
| Partner Positive Mood Manipulation | Active comparator | Behavioral: Partner Positive Mood ManipulationParticipants receive an experimental manipulation describing positive emotions in a hypothetical sexual partner. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcoholic BeverageParticipants 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. | Behavioural | Alcoholic beverage |
| Non-alcoholic BeverageParticipants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. | Behavioural | Non-alcoholic beverage |
| Partner Negative Mood ManipulationParticipants will engage in a laboratory task and will then report their own and their partner's emotions following the task. | Behavioural | Partner Negative Mood Manipulation |
| Partner Positive Mood ManipulationParticipants will engage in a laboratory task and will then report their own and their partner's emotions following the task. | Behavioural | Partner Positive Mood Manipulation |
Primary outcome
Mean score of sexual risk intentions
Time frame: within one hour of receiving the intervention
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.
1 secondary outcome
Sexual risk behavior
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. We will make available individual, de-identified participant data that underlie disseminated results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nolan Eldridge contact
Kelly Davis, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcoholic Beverage, Non-alcoholic Beverage and Partner Negative Mood Manipulation in people with Sexual Behavior and Alcohol Drinking, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Davis, PhD (6024963217, Kelly.Cue.Davis@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score of sexual risk intentions (time frame: within one hour of receiving the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.