Sexual BehaviorNCT03900650
Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
A study testing High provocation manipulation, Low provocation manipulation and Alcoholic beverage in people with Sexual Behavior and Alcohol Drinking, run by Arizona State University at 1 site in United States.
Trial summary
Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors… 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?
- High provocation manipulation, Low provocation manipulation and Alcoholic beverage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 times 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.
About this study
Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.
- Conditions
- Sexual Behavior, Alcohol Drinking, Sexual Aggression, Emotions
- Being tested
- High provocation manipulation, Low provocation manipulation, Alcoholic beverage, Non-alcoholic beverage
- 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.
High provocation manipulationBehavioural
Participants will engage in a laboratory task and will then report their emotions following the task.
Low provocation manipulationBehavioural
Participants will engage in a laboratory task and will then report their emotions following the task.
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.
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic beverage, High Provocation Manipulation | Experimental | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. Receives: Behavioral: High provocation manipulation; Behavioral: Alcoholic beverage |
| Non-alcoholic beverage, High Provocation Manipulation | Experimental | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. Receives: Behavioral: High provocation manipulation; Behavioral: Non-alcoholic beverage |
| Alcoholic beverage, Low provocation manipulation | Experimental | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. Receives: Behavioral: Low provocation manipulation; Behavioral: Alcoholic beverage |
| Non-alcoholic beverage, Low provocation manipulation | Experimental | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Receives: Behavioral: Low provocation manipulation; Behavioral: Non-alcoholic beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score of Sexual Risk Intentions
Scale name: Intentions to have unprotected sex Construct: 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
Sexual Risk Behavior
Number of unprotected sexual intercourse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start7 Mar 2019
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 420 participants (actual)
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
- NCT03900650
- Sponsor's protocol ID
- STUDY00008097
- Other IDs
- 5R37AA025212
- Status last verified
- Nov 2023
- First submitted
- 28 Mar 2019
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Nov 2023. 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
- ClinicalTrials.gov ID
- NCT03900650
- Acronym / sponsor ID
- STUDY00008097
- Conditions
- Sexual Behavior, Alcohol Drinking, Sexual Aggression, Emotions
- Keywords
- Condom use resistance, Emotion dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Georgia State University
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcoholic beverage, High Provocation Manipulation | Experimental | Behavioral: High provocation manipulation, Behavioral: Alcoholic beverageParticipants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. |
| Non-alcoholic beverage, High Provocation Manipulation | Experimental | Behavioral: High provocation manipulation, Behavioral: Non-alcoholic beverageParticipants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. |
| Alcoholic beverage, Low provocation manipulation | Experimental | Behavioral: Low provocation manipulation, Behavioral: Alcoholic beverageParticipants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. |
| Non-alcoholic beverage, Low provocation manipulation | Experimental | Behavioral: Low provocation manipulation, Behavioral: Non-alcoholic beverageParticipants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. |
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 2 times 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 |
|---|---|---|
| High provocation manipulationParticipants will engage in a laboratory task and will then report their emotions following the task. | Behavioural | Alcoholic beverage, High Provocation Manipulation, Non-alcoholic beverage, High Provocation Manipulation |
| Low provocation manipulationParticipants will engage in a laboratory task and will then report their emotions following the task. | Behavioural | Alcoholic beverage, Low provocation manipulation, Non-alcoholic beverage, Low provocation manipulation |
| 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, High Provocation Manipulation, Alcoholic beverage, Low provocation manipulation |
| 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, High Provocation Manipulation, Non-alcoholic beverage, Low provocation manipulation |
Primary outcome
Mean Score of Sexual Risk Intentions
Time frame: within one hour of receiving the intervention
Scale name: Intentions to have unprotected sex Construct: 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.
Sexual Risk Behavior
Time frame: 30 days
Number of unprotected sexual intercourse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 High provocation manipulation, Low provocation manipulation and Alcoholic beverage 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: finished, as of the sponsor's last update on 29 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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). The study lists 2 primary outcomes in all. 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 29 Nov 2023.