Stress Tests for Stress-Related Alcohol Consumption

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Texas Tech University

Must not be taking: Essential medications

Disqualifiers: Pregnancy, Substance use treatment, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how stress related to uncertainty about sexual orientation affects drinking behavior, particularly in individuals who identify as bisexual or bi+. Researchers will examine the interaction between stress from social situations and alcohol consumption, focusing on how these factors might contribute to alcohol-use disparities. Participants will receive either alcoholic (ethanol) or non-alcoholic (placebo) drinks and will prepare speeches on various topics to assess their stress responses. This trial suits cisgender individuals aged 21-29 who feel uncertain about their sexual orientation and have a mild to moderate risk for alcohol use issues. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on essential medications that do not allow alcohol consumption, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ethanol, the type of alcohol in drinks, affects the body in various ways. Drinking alcohol can increase stress, especially in those already prone to it. Studies have found that stress can lead to stronger cravings for alcohol and more drinking. Understanding the risks is important. Ethanol can raise the chances of health issues, worsening stress-related problems and affecting organ function.

The Trier Social Stress Test (TSST) creates stress in a controlled environment for research purposes. It helps scientists study how stress influences behaviors, such as drinking. The TSST is usually well-tolerated, but when combined with alcohol, it can increase cravings and drinking in some individuals.

Overall, ethanol has both social and health effects. Research has linked it to various health risks, especially when combined with stress. Prospective participants in a study involving ethanol should consider these factors carefully. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how stress impacts alcohol consumption, using a unique approach with the Trier Social Stress Test (TSST). Unlike traditional methods that focus on treating alcohol use disorders once they develop, this trial investigates the root causes by simulating social stress and observing its effect on drinking behavior. By using different scenarios—control, relevant, and irrelevant stressors—paired with either ethanol or placebo beverages, researchers hope to uncover detailed insights into the link between stress and alcohol use. This could lead to innovative prevention strategies, potentially changing how we address stress-related drinking before it becomes a disorder.

What evidence suggests that this trial's treatments could be effective for stress-related alcohol consumption?

Research has shown that alcohol, specifically ethanol, can help reduce stress and anxiety. This trial will explore how different stress conditions affect alcohol consumption. Participants in some arms will receive ethanol, while others will receive a placebo beverage. Studies indicate that stress can lead to increased alcohol consumption, and alcohol can, in turn, help ease stress. Ethanol is known to facilitate social interactions, which might help reduce anxiety. Early findings suggest that when people face stress, such as uncertainty about their sexual orientation, they might drink more to cope. This pattern is especially common in communities with higher rates of alcohol use. Understanding this can aid in developing better ways to manage stress and alcohol consumption. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for cisgender adults aged 21-29 who are uncertain about their sexual orientation or identify as bisexual/bi+, and have mild to moderate risk of alcohol use disorder. It excludes those with no history of alcohol use, pregnant women, individuals in substance abuse treatment, on certain medications, or at high risk for alcohol use disorder.

Inclusion Criteria

Scores on the Alcohol Use Disorders Identification Test (AUDIT) that indicate mild or moderate risk for potential alcohol use disorder

I identify with the gender I was assigned at birth.

I am between 21 and 29 years old.

Exclusion Criteria

Alcohol naive persons (i.e., those without a history of alcohol use in their lifetime)

Persons with scores on the Alcohol Use Disorders Identification Test (AUDIT) that indicate high risk for potential alcohol use disorder; National Institute of Alcohol Abuse and Alcoholism (NIAAA) standard drink equivalencies will be provided in the survey.

I take medication that requires me to avoid alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Session

Participants undergo the Trier Social Stress Test and consume beverages with or without ethanol

1 day

1 visit (in-person)

Follow-up

Participants are monitored for physiological and psychological responses post-consumption

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ethanol
• Placebo Beverage
• Placebo Trier Social Stressor Test (TSST)
• Relevant and Irrelevant Trier Social Stressor Test (TSST)

Trial Overview The study tests how internalized stress related to sexual orientation uncertainty affects heavy drinking behavior. Participants will be exposed to different stress tests and given either ethanol or a placebo beverage to see if this influences their subsequent alcohol consumption.

How Is the Trial Designed?

Group I: Relevant Stressor Condition with No Ethanol Experimental Treatment 2 Interventions

Participants complete the Relevant Trier Social Stress Test (TSST), which asks participants to prepare a 5-minute speech on how their sexuality has developed over time. Participants are then assigned to receive a placebo priming beverage (with no ethanol) to consume over 10 minutes. Participants will consume the initial placebo drink, which is intended as a priming cue. Next, participants will be given a free period of an additional 20 minutes in which participants can consume up to three additional placebo cocktails, which do not contain ethanol.

Group II: Relevant Stressor Condition with Ethanol Experimental Treatment 2 Interventions

Participants complete the Relevant Trier Social Stress Test (TSST), which asks participants to prepare a 5-minute speech on how their sexuality has developed over time. Participants are then assigned to receive a priming beverage containing ethanol to consume over 10 minutes. Participants will consume the initial drink containing ethanol, which is intended as a priming dose. Next, participants will be given a free period of an additional 20 minutes in which participants can consume up to three additional cocktails, which contain ethanol. The initial drink in the alcohol condition will contain 0.3 g/kg (males) or 0.2 g/kg (females) of 80-proof ethanol, adjusted for body weight, and subsequent drinks will contain 0.1 g/kg of ethanol.

Group III: Irrelevant Stressor Condition with No Ethanol Active Control 2 Interventions

Participants complete the Irrelevant Trier Social Stress Test (TSST), which asks participants to prepare a 5-minute speech on how their gender identity has developed over time. Participants are then assigned to receive a placebo priming beverage (with no ethanol) to consume over 10 minutes. Participants will consume the initial placebo drink, which is intended as a priming cue. Next, participants will be given a free period of an additional 20 minutes in which participants can consume up to three additional placebo cocktails, which do not contain ethanol.

Group IV: Irrelevant Stressor Condition with Ethanol Active Control 2 Interventions

Participants complete the Irrelevant Trier Social Stress Test (TSST), which asks participants to prepare a 5-minute speech on how their gender identity has developed over time. Participants are then assigned to receive a priming beverage containing ethanol to consume over 10 minutes. Participants will consume the initial drink containing ethanol, which is intended as a priming dose. Next, participants will be given a free period of an additional 20 minutes in which participants can consume up to three additional cocktails, which contain ethanol. The initial drink in the alcohol condition will contain 0.3 g/kg (males) or 0.2 g/kg (females) of 80-proof ethanol, adjusted for body weight, and subsequent drinks will contain 0.1 g/kg of ethanol.

Group V: Control Stressor Condition with Ethanol Placebo Group 2 Interventions

Participants complete the Control Trier Social Stress Test (TSST), which asks participants to prepare a 5-minute speech on a recent book participants read, or a recent movie participants saw. Participants are then assigned to receive a priming beverage containing ethanol to consume over 10 minutes. Participants will consume the initial drink containing ethanol, which is intended as a priming dose. Next, participants will be given a free period of an additional 20 minutes in which participants can consume up to three additional cocktails, which contain ethanol. The initial drink in the alcohol condition will contain 0.3 g/kg (males) or 0.2 g/kg (females) of 80-proof ethanol, adjusted for body weight, and subsequent drinks will contain 0.1 g/kg of ethanol.

Group VI: Control Stressor Condition with No Ethanol Placebo Group 2 Interventions

Participants complete the Control Trier Social Stress Test (TSST), which asks participants to prepare a 5-minute speech on a recent book participants read, or a recent movie participants saw. Participants are then assigned to receive a placebo priming beverage (with no ethanol) to consume over 10 minutes. Participants will consume the initial placebo drink, which is intended as a priming cue. Next, participants will be given a free period of an additional 20 minutes in which participants can consume up to three additional placebo cocktails, which do not contain ethanol.

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

Published Research Related to This Trial

Stress appears to influence alcohol consumption differently across various demographics, with adolescents showing a correlation between stress and increased drinking, while women and the elderly do not exhibit the same pattern.

Alcohol may serve as a self-medication tool for individuals with anxiety disorders, such as agoraphobia, potentially leading to increased alcohol abuse, although the relationship between alcohol and stress is complex and varies by individual and context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress and alcohol interaction: an update of human research. Pohorecky, LA.[2019]

In a study with 20 male volunteers, acute social stress increased the sedative effects of ethanol while decreasing its stimulant effects, suggesting that stress can alter how alcohol affects mood.

Despite the increased sedative effects, stress did not lead to a greater desire for more alcohol, indicating that the relationship between stress and alcohol consumption may be complex and varies by individual.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of stress and alcohol on subjective state in humans. Söderpalm, AH., de Wit, H.[2019]

The study validated a remote version of the Trier Social Stress Test (TSST-Online) for children, demonstrating that it effectively activates the stress response similar to in-person assessments, with 63% of participants showing a significant increase in cortisol levels.

The TSST-Online allows for safe and effective assessment of stress reactivity in children and adolescents without the need for in-person visits, making it particularly useful during situations like the COVID-19 pandemic or for participants living far from research facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of an online version of the Trier Social Stress Test in a study of adolescents. Gunnar, MR., Reid, BM., Donzella, B., et al.[2023]

In a study involving adult squirrel monkeys, social stressors of varying lengths and intensities were found to have different effects on alcohol consumption, with chronic social subordination linked to increased drinking.

Acute social separation led to a decrease in alcohol intake and increased anxiety-like behavior, while extended social separation resulted in higher alcohol consumption in males, indicating that the type and duration of social stress can significantly influence alcohol self-administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social rank and social separation as determinants of alcohol drinking in squirrel monkeys. McKenzie-Quirk, SD., Miczek, KA.[2021]

Chronic physical and psychological stressors significantly increase ethanol (ET) consumption in animals, with individual differences in preference affecting this response, indicating a complex interaction between stress and alcohol intake.

Ethanol appears to mitigate some stress-induced neurochemical changes in the brain, such as reducing decreases in noradrenaline and serotonin levels, suggesting potential mechanisms involving the GABA-benzodiazepine system and the hypothalamo-pituitary-adrenocortical axis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interaction of ethanol and stress: research with experimental animals--an update. Pohorecky, LA.[2019]

The Trier Social Stress Test (TSST) is identified as the most effective standardized protocol for inducing a psychological stress response in laboratory settings, leading to measurable increases in heart rate, blood pressure, and stress hormones like cortisol.

The TSST allows researchers to assess individual differences in stress reactivity and anxiety, making it a valuable tool for comparing treatment effects between clinical and healthy populations, while also utilizing less invasive salivary sampling methods for stress markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trier Social Stress Test protocol for inducing psychological stress. Birkett, MA.[2022]

The Trier Social Stress Test in group format (TSST-G) effectively induces a psychobiological stress response, as shown by significant increases in negative affect, heart rate (HR), and salivary alpha-amylase (sAA) in a study with 294 participants during the first test.

When comparing two different protocols for the second test, the defensive speech protocol resulted in a stronger autonomic stress response (higher HR and lower heart rate variability) than a neutral presentation, indicating that ego-involving tasks may be more effective for studying stress reactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mood and autonomic responses to repeated exposure to the Trier Social Stress Test for Groups (TSST-G). Boesch, M., Sefidan, S., Ehlert, U., et al.[2014]

A restraint stressor significantly increases ethanol drinking and anxiety-like behavior in ethanol-preferring rats, highlighting the impact of stress on alcohol consumption and anxiety.

Blocking CRF-1 receptors in the nucleus accumbens (NAC) effectively prevents increased drinking, while blocking receptors in the amygdala (Amyg) or dorsal raphe nucleus (DRN) reduces anxiety-like behavior, indicating distinct brain regions are involved in these responses to stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a stressor and corticotrophin releasing factor on ethanol deprivation-induced ethanol intake and anxiety-like behavior in alcohol-preferring P rats. Knapp, DJ., Overstreet, DH., Huang, M., et al.[2021]

Ethanol has been shown to counteract some effects of stress, improving performance and affective states in humans and animals, but its effectiveness in reducing anxiety is inconsistent and influenced by various factors such as environment and individual differences.

In alcoholics, ethanol does not relieve anxiety and may actually increase it during drinking binges, highlighting the need for further research to understand the complex relationship between alcohol use and stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interaction of alcohol and stress. A review. Pohorecky, LA.[2019]

The Trier Social Stress Test (TSST) effectively induces physiological stress responses in youth, as evidenced by significant increases in salivary cortisol, heart rate, and systolic blood pressure among 5026 participants across 57 studies.

The effectiveness of the TSST varies by physiological marker and is influenced by factors such as age, gender, and the specific conditions of the test, indicating that while the TSST is a valid stressor for youth, some markers may be more reliable than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the effectiveness of the Trier Social Stress Test in eliciting physiological stress responses in children and adolescents. Seddon, JA., Rodriguez, VJ., Provencher, Y., et al.[2021]

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