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

165 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment for stress-related alcohol consumption?

Research suggests that stress can increase alcohol intake, and alcohol may reduce some stress effects, like anxiety and tremors, in certain individuals. However, the effectiveness of alcohol in reducing stress is inconsistent and varies based on individual factors and conditions. ^{1 2 3 4 5}

Is the Trier Social Stress Test (TSST) safe for humans?

The Trier Social Stress Test (TSST) is widely used in research to induce stress responses in humans, and it has been shown to reliably increase heart rate, blood pressure, and stress hormones like cortisol in healthy volunteers. It is generally considered safe for use in controlled research settings. ^{4 6 7 8 9}

How is the treatment for stress-related alcohol consumption unique?

This treatment is unique because it combines stress tests and placebo-controlled conditions to study how stress influences alcohol consumption, which is different from typical treatments that focus solely on reducing alcohol intake without considering the role of stress. ^{1 2 3 5 10}

What is the purpose of this trial?

The proposed study uses an experimental design to establish causal support for the role of internalized stress, pertaining to uncertainty with regard to one's sexual orientation, in contributing to heavy drinking behavior. Following exposure to internalized sexual stigma, physiological and psychological stress responses are expected to increase alcohol consumption in adults who are uncertain about their sexual orientation, especially among females, and following consumption, the physiological effects of ethanol and beliefs about the effects of alcohol are expected to alter relations between exposure to sexual stigma and the alleviation of psychological distress. Showing that physiological stress responses, whether driven by the pharmacological effects of ethanol or expectancies regarding its effects, can account for known alcohol-use disparities, particularly in bisexual/bi+ communities, would contribute a great deal to knowledge on the biology of addiction and inform subsequent interventions that seek to regulate stress reactivity.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Effects of stress and alcohol on subjective state in humans. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Validation of an online version of the Trier Social Stress Test in a study of adolescents. [2023]

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Mood and autonomic responses to repeated exposure to the Trier Social Stress Test for Groups (TSST-G). [2014]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

Social rank and social separation as determinants of alcohol drinking in squirrel monkeys. [2021]