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Alcoholic beverage for Sexual Assault

N/A

Waitlist Available

Led By Kelly Davis, PhD

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial looks at the emotional factors that lead to young men not using condoms and engaging in other sexual risk behaviors. It uses multiple methods to gather data and will help inform prevention and intervention programs.

Eligible Conditions

Sexual Assault
Alcohol Consumption
Sexual Activity
Emotions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one hour of receiving the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within one hour of receiving the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and within one hour of receiving the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Score of Sexual Risk Intentions

Sexual Risk Behavior

Side effects data

From 2011 Phase 1 trial • 28 Patients • NCT01380691

10%

Menstruation irregular

10%

Pelvic pain

Non-cardiac chest pain

Dizziness

Headache

Haematochezia

Hyperhidrosis

Vomiting

Nausea

Palpitations

Ear pain

Somnolence

Burns first degree

100%

80%

60%

40%

20%

Study treatment Arm

LY2216684 + Alcohol

LY2216684 + Placebo-matching Alcohol

Placebo-matching LY2216684 + Placebo-matching Alcohol

Placebo-matching LY2216684 + Alcohol

Trial Design

4Treatment groups

Experimental Treatment

Group I: Non-alcoholic beverage, Low provocation manipulationExperimental Treatment2 Interventions

Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions.

Group II: Non-alcoholic beverage, High Provocation ManipulationExperimental Treatment2 Interventions

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.

Group III: Alcoholic beverage, Low provocation manipulationExperimental Treatment2 Interventions

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.

Group IV: Alcoholic beverage, High Provocation ManipulationExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low provocation manipulation

2019

N/A

~420

High provocation manipulation

2019

N/A

~420

Non-alcoholic beverage

2019

N/A

~420

Alcoholic beverage

2019

Completed Phase 1

~450

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

799 Previous Clinical Trials

1,362,091 Total Patients Enrolled

4 Trials studying Sexual Assault

554 Patients Enrolled for Sexual Assault

Arizona State UniversityLead Sponsor

283 Previous Clinical Trials

109,094 Total Patients Enrolled

2 Trials studying Sexual Assault

3,465 Patients Enrolled for Sexual Assault

Georgia State UniversityOTHER

57 Previous Clinical Trials

25,009 Total Patients Enrolled

2 Trials studying Sexual Assault

3,465 Patients Enrolled for Sexual Assault

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently recruitment for this research endeavor?

"Affirmative. According to information posted on clinicaltrials.gov, the trial is actively enrolling participants since it was first shared on March 7th 2019 and its most recent update occurring May 19th 2022. The total target number of patients needed for this study across one site is 420 individuals."

Answered by AI

Is the age restriction for this trial surpassing eighty years?

"The terms of participation in this trial necessitate that applicants are between 21 and 30 years old. There exist 47 studies for minors below 18, as well as 220 trials available to those over 65."

Answered by AI

Could I be eligible to participate in this experiment?

"This trial requires that participants between 21 and 30 years old have an alcohol drinking history. Currently, 420 individuals are sought after to join the study."

Answered by AI

To what extent are volunteers involved in this research?

"Affirmative. According to information hosted on clinicaltrials.gov, this experiment began recruitment on March 7th 2019 and is presently seeking 420 candidates from one centre. The posting was most recently updated on May 19th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03900650.