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

NCT04192448 | Terminated Results

• 2 other identifiers: 19-10-132P20GM103436
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcohol Intoxication; Anger

Keywords

Sexual Violence; Alcohol consumption

Outcome Measures

Primary Outcomes (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

  20 minutes

Secondary Outcomes (2)

• Physical Aggression Intentions

  20 minutes

• Psychological Aggression Intentions

  20 minutes

Study Arms (4)

AlcoholxAnger

EXPERIMENTAL

Participant 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.

Other: Alcohol Administration; Other: Mood Induction

AlcoholxControl

EXPERIMENTAL

Participant 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.

Other: Alcohol Administration; Other: Mood Induction

SoberxAnger

EXPERIMENTAL

Participant 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.

Other: Alcohol Administration; Other: Mood Induction

SoberxControl

SHAM COMPARATOR

Participant 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.

Other: Alcohol Administration; Other: Mood Induction

Interventions

Alcohol Administration OTHER

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

AlcoholxAnger; AlcoholxControl; SoberxAnger; SoberxControl

Mood Induction OTHER

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.

AlcoholxAnger; AlcoholxControl; SoberxAnger; SoberxControl

Eligibility Criteria

• Age: 21 Years - 35 Years
• Gender Eligibility Details: Participants must be biologically male participants whose gender identity is male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elizabeth C Neilson: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Morehead State University

Morehead, Kentucky, 40351, United States

Location

Related Publications (9)

• 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.

  PMID: 28375675 BACKGROUND

• 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.

  PMID: 12022717 BACKGROUND

• 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.

  PMID: 26048214 BACKGROUND

• 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.

  PMID: 29606897 BACKGROUND

• 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.

  PMID: 17690811 BACKGROUND

• 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.

  PMID: 8271813 BACKGROUND

• 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.

  PMID: 9358690 BACKGROUND

• 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.

  PMID: 19515289 BACKGROUND

• 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.

  PMID: 29348701 BACKGROUND

Related Links

• Recommended council guidelines on ethyl alcohol administration in human experimentation

MeSH Terms

Conditions

Alcoholic Intoxication; Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

The most notable limitation to the current study is the sample size. The study was terminated after three participants were enrolled from October 2020 to May 2021. Extensive efforts were undertaken to improve recruitment, however administrative limitations placed upon the study by the institution and the ongoing COVID-19 pandemic presented barriers to recruitment. While the Results presented indicate the scores obtained from the data, the sample is too small to draw any meaningful conclusions.

Results Point of Contact

• Title: Elizabeth Neilson
• Organization: Eastern Michigan University

eneilso1@emich.edu

734-487-4988

Study Officials

• Elizabeth C Neilson, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will only be blind to emotion condition. Participants will be informed of their alcohol condition. Investigator and experimenter will be aware of participants' assigned condition.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 10, 2019
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)