An interventional study of Alcohol Administration and Mood Induction in Alcohol Intoxication and Anger, sponsored by Elizabeth C Neilson. Terminated at 1 site in United States. Open to male participants aged 21 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Elizabeth C Neilson · Not applicable, Interventional, and Basic science
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.
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.
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
This study's enrollment of 3 is below the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →This is the only study on the registry with Elizabeth C Neilson as lead sponsor.
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Exclusion Criteria:
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
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
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
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
The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
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.
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
Time frame: 20 minutes
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
Time frame: 20 minutes
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
Time frame: 20 minutes
Recruitment for the study began in September 2020 after IRB approval was obtained for study modifications necessary to comply with COVID-related safety precautions. Advertisements were placed in local business, emphasizing alcohol-serving establishments, and authorized posting areas in local community colleges and four-year universities. Online advertisements were posted in social media sites (e.g., Facebook, Instagram) and forums (e.g., Reddit, Craiglist). Recruitment continued until May 2021.
| Milestone | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl |
|---|---|---|---|---|
| Started | 1 | 1 | 0 | 1 |
| Completed | 1 | 1 | 0 | 1 |
| Not completed | 0 | 0 | 0 | 0 |
Mean score of 22 items assessing behavioral intentions (1 = Not at Likely to 7 = Very Likely) to act sexually aggressively against a hypothetical female
| score on a scale | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl |
|---|---|---|---|---|
| Sexual Aggression Intentions | 2.18 | 4.73 | — | 1.64 |
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
| score on a scale | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl |
|---|---|---|---|---|
| Physical Aggression Intentions | 1.0 | 1.25 | — | 1.0 |
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
| score on a scale | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl |
|---|---|---|---|---|
| Psychological Aggression Intentions | 1.67 | 2.33 | — | 1.33 |
Collected over Adverse event data were directly collected during the course of a participant's engagement in the study, which was approximately 5 to 7 1/2 hours. Participants were provided with contact information for the research team and IRB and encouraged to contact either the PI or IRB if they believed they had been negatively affected by the study. The PI monitored study email and voicemail for 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AlcoholxAnger | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| AlcoholxControl | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| SoberxAnger | — | — | — |
| SoberxControl | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
The baseline population met all the inclusion criteria as outlined in the initial proposal, thus were cisgender men who engaged in moderate to heavy drinking and sexual risk-taking. The number enrolled is substantively different than proposed due to administrative barriers to the study and COVID-related barriers that impacted recruitment (closure of alcohol-serving establishments, community concern regarding participation in in-person studies during the pandemic).
| Age, Continuous(years) | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl | Total |
|---|---|---|---|---|---|
| Mean | 31 ± 0 | 35 ± 0 | — | 30 ± 0 | 32 ± 2.65 |
| Sex: Female, Male(Participants) | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 1 | 1 | 0 | 1 | 3 |
| Race/Ethnicity, Customized(Participants) | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl | Total |
|---|---|---|---|---|---|
| Race and Ethnicity — White/Non-Latino | 1 | 1 | 0 | 0 | 2 |
| Race and Ethnicity — Black or African American/Non-Latino | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment(Participants) | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl | Total |
|---|---|---|---|---|---|
| United States | 1 | 1 | 0 | 1 | 3 |
| Sexual Experiences Survey(units on a scale) | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl | Total |
|---|---|---|---|---|---|
| Mean | 3 ± 0 | 0 ± 0 | — | 4 ± 0 | 2.33 ± 2.08 |
| Difficulties in Emotion Regulation Scale(units on a scale) | AlcoholxAnger | AlcoholxControl | SoberxAnger | SoberxControl | Total |
|---|---|---|---|---|---|
| Mean | 88 ± 0 | 62 ± 0 | — | 73 ± 0 | 74.33 ± 13.05 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2020 to primary completion in Aug 2021, 11 months.
Results were first posted in May 2024, 2 years 8 months after primary completion.
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