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Alcohol IntoxicationMMANCT04192448

Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression

A study testing Alcohol Administration and Mood Induction in people with Alcohol Intoxication and Anger, run by Elizabeth C Neilson at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. Read more about this study

Who is it for?
Ages 21 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Alcohol Intoxication, Anger
What is being tested?
Alcohol Administration and Mood Induction
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 31 Aug 2021
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 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Biologically male and identify their gender as male
  • Between the ages of 21-35
  • Must be Interested in sexual activity with women
  • Must have engaged in at least one instance of sex without a condom in the last six months
  • Must on average consume between 5 and 25 standard drinks per week
  • Must have previously had an instance of heavy episodic drinking (HED; at least five alcoholic drinks in two hours) in the last six months
  • No history of or current alcohol problems (as determined by the Brief Michigan Alcoholism Screening Test)
  • No past or current medical condition or take medications which contraindicate alcohol consumption

Who cannot join

  • being in a monogamous relationship of longer than six months or not having sexual intercourse at all within the past six months
  • Any history or current alcohol problems (as determined by the Brief Michigan Alcoholism Screening Test)
  • Currently taking medications which contraindicate alcohol consumption
  • Currently or ever diagnosed with a medical condition that contraindicates alcohol consumption
  • Currently enrolled as a student at Morehead State University

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Morehead State University

    Morehead, Kentucky, 40351

Other trials in United States

About this study

Official title: The Roles of Acute Alcohol Intoxication, State Anger, and Emotion Regulation on Men's Sexual Aggression Intentions

Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition [alcohol (target BAC= .08gm%) or control (no alcohol control)] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.

Read the detailed description

Males ages 21 to 35 will be recruited from the community through fliers and advertisements in bars and local publications (print and electronic) and instructed to call the lab for telephone screening or complete an online web-screening survey. Sexual aggression is a pervasive and highly prevalent problem on college campuses, so the project will heavily advertise at the local college campus. The screening will include an assessment of typical alcohol consumption patterns, risk for current or past alcohol use disorder, and sexual risk-taking.

Participants (N=180) will be compensated $10 per hour of lab participation for a maximum payment of $80. Participants will begin by completing a series of background measures (see Measures) related to alcohol consumption and expectations, sexual aggression perpetration history, trait anger, and trait emotion regulation. Participants will complete factors of personality that have demonstrated associations with both emotion regulation and sexual aggression as covariates, including psychopathy, sensation seeking, and impulsivity.

Participants will be randomly assigned to receive beverages consisting of either an alcohol dose (target peak BAC =.08gm%) or a control (non-alcoholic) beverage. Participants will be informed into which alcohol condition they have been assigned. Using a double-blind procedure, participants will be block randomized by self-reported sexual aggression perpetration history [(none = no history of perpetration) vs. (low = history of unwanted sexual contact or sexual coercion) vs. (high = attempted or completed perpetration of incapacitated or forced rape)]. A computer algorithm will be used to assign participants to the experimental conditions such that participants with none, low, and high perpetration history are evenly distributed across beverage conditions. Individuals assigned to the alcohol condition will consume a beverage comprised of cranberry juice and 100 proof vodka, while individuals assigned to the control condition will consume a beverage comprised of cranberry juice and water. The total liquid is divided equally between three cups, and participant is given nine minutes to consume the total amount (e.g., three minutes per cup). To ensure stable absorption of alcohol and decrease the likelihood of nausea, the experimenter will instruct the participant to consume the beverages evenly and to avoid drinking quickly. Following beverage administration, participants will be Breathalyzed every five minutes until they attain two Breathalyzer readings of .08%gm to ensure their BAC will descend during the emotion induction and sexual aggression analog. A yoking procedure will be employed for control participants in which each control participant is paired with an alcohol dose participant and receive an equal number of Breathalyzer checks.

Participants will also be randomly assigned to an emotion induction condition consisting of either an anger emotion induction or a control emotion induction. This study will employ deception as individuals will not be told they have been assigned to different emotion induction conditions. The emotion induction consists of two parts: 1) an emotion recall task; and 2) provocation task. Individuals assigned to the anger induction will be instructed to recall an incident in the last 30 days when they felt angry, frustrated, or "pissed off". They will then be given five minutes to write as much as possible about that incident and their response. Participants in the control condition will be instructed to write for five minutes about a neutral topic (e.g., cooking dinner, going for a walk; Marci et al., 2007). The writing samples from all participants will be collected and coded by independent coders to identify whether participants accurately engaged in the task. Following the emotion recall portion of the induction, participants will begin a provocation task. Both groups will begin an attention task. Participants assigned to the anger condition will be given negative feedback about their performance. Participants assigned to the control condition will complete the task without feedback and then will be thanked for their participation.

Upon completion of both portions of the emotion induction, participants will read and project themselves into a written hypothetical sexual situation displayed on a computer. The stimulus story will be approximately 1,600 words and be written at a 5th grade reading level. The story will depict a sexual encounter between the participant and a hypothetical female, in which the female in the story will initially engage in consensual sexual activity however will gradually display and express resistance to engaging in intercourse. Participants will then complete assessment of outcome measures.

Immediately after completing the scenario, participants will be required to watch one of three neutral videos (e.g., comedy clips, nature documentaries) to assist with distancing and detaching from the content of the story. After completing the videos, sober participants will be debriefed and paid for their time. Intoxicated participants will be provided with food, beverages, and entertainment until their BAC descended to below .04%gm. Once their BAC has descended to below .04%gm, these participants will be debriefed and paid for their time.

Being tested
Alcohol Administration, Mood Induction
Keywords
Sexual Violence, Alcohol consumption
Medical subject headings
Alcoholic Intoxication, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alcohol AdministrationOther

    The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).

  • Mood InductionOther

    The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.

Study groups in NCT04192448
Study groupRoleWhat they receive
AlcoholxAngerExperimentalParticipant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Receives: Other: Alcohol Administration; Other: Mood Induction
AlcoholxControlExperimentalParticipant will receive alcohol, the dose of which will be administered to result in a BAC of .08%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Receives: Other: Alcohol Administration; Other: Mood Induction
SoberxAngerExperimentalParticipant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
Receives: Other: Alcohol Administration; Other: Mood Induction
SoberxControlSham comparatorParticipant will not receive alcohol, therefore their BAC will be .00%. Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
Receives: Other: Alcohol Administration; Other: Mood Induction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexual Aggression Intentions

    Mean score of 22 items assessing behavioral intentions (1 = Not at Likely to 7 = Very Likely) to act sexually aggressively against a hypothetical female

    Measured: 20 minutes

Secondary outcomes (2)
  1. Physical Aggression Intentions

    Mean score of 5 items assessing behavioral intentions (1 = Not at All to 7 = Extremely) of intentions to act physically aggressively against a hypothetical female

    Measured: 20 minutes

  2. Psychological Aggression Intentions

    Mean score of 3 items assessing behavioral intentions (1 = Not at All to 7 = Extremely) of intentions to act psychologically aggressively against a hypothetical female

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2019
  2. Study start1 Sep 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Why it stopped: Procedures not feasible due to COVID-19 and administrative concerns

Resources

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
Parallel groups
Model description
The study utilizes a 2x2 (Alcohol and Emotion) design in which participants will be randomly assigned to one of four groups: AlcoholxAnger, AlcoholxControl, SoberxAnger, SoberxControl
Masking
Single blind
Who is masked
Participant
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04192448
Sponsor's protocol ID
19-10-13
Other IDs
2P20GM103436
Acronym
MMA
Status last verified
May 2024
First submitted
7 Dec 2019
Last updated
29 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Muehlenhard CL, Peterson ZD, Humphreys TP, Jozkowski KN. Evaluating the One-in-Five Statistic: Women's Risk of Sexual Assault While in College. J Sex Res. 2017 May-Jun;54(4-5):549-576. doi: 10.1080/00224499.2017.1295014. Epub 2017 Apr 4.

    PubMed 28375675
  • Abbey A. Alcohol-related sexual assault: a common problem among college students. J Stud Alcohol Suppl. 2002 Mar;(14):118-28. doi: 10.15288/jsas.2002.s14.118.

    PubMed 12022717
  • Abbey A, Wegner R. Using Experimental Paradigms to Examine Alcohol's Role in Men's Sexual Aggression: Opportunities and Challenges in Proxy Development. Violence Against Women. 2015 Aug;21(8):975-96. doi: 10.1177/1077801215589378. Epub 2015 Jun 5.

    PubMed 26048214
  • DeGue S, Valle LA, Holt MK, Massetti GM, Matjasko JL, Tharp AT. A systematic review of primary prevention strategies for sexual violence perpetration. Aggress Violent Behav. 2014 Jul-Aug;19(4):346-362. doi: 10.1016/j.avb.2014.05.004.

    PubMed 29606897
  • Connor JP, Grier M, Feeney GF, Young RM. The validity of the Brief Michigan Alcohol Screening Test (bMAST) as a problem drinking severity measure. J Stud Alcohol Drugs. 2007 Sep;68(5):771-79. doi: 10.15288/jsad.2007.68.771.

    PubMed 17690811
  • Martin CS, Sayette MA. Experimental design in alcohol administration research: limitations and alternatives in the manipulation of dosage-set. J Stud Alcohol. 1993 Nov;54(6):750-61. doi: 10.15288/jsa.1993.54.750.

    PubMed 8271813
  • Giancola PR, Zeichner A. The biphasic effects of alcohol on human physical aggression. J Abnorm Psychol. 1997 Nov;106(4):598-607. doi: 10.1037//0021-843x.106.4.598.

    PubMed 9358690
  • Davis KC, George WH, Norris J, Schacht RL, Stoner SA, Hendershot CS, Kajumulo KF. Effects of alcohol and blood alcohol concentration limb on sexual risk-taking intentions. J Stud Alcohol Drugs. 2009 Jul;70(4):499-507. doi: 10.15288/jsad.2009.70.499.

    PubMed 19515289
  • Laber EB, Shedden K. Statistical Significance and the Dichotomization of Evidence: The Relevance of the ASA Statement on Statistical Significance and p-values for Statisticians. J Am Stat Assoc. 2017;112(519):902-904. doi: 10.1080/01621459.2017.1311265. Epub 2017 Oct 30. No abstract available.

    PubMed 29348701

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol Administration and Mood Induction in people with Alcohol Intoxication and Anger, run by Elizabeth C Neilson 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 May 2024. 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. Some participants in this study may receive a placebo. 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 May 2024). 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?

Sexual Aggression Intentions (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04192448, which also lists 9 linked publications.

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 May 2024.

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