Internalized Stress in Relation to Alcohol Consumption

Stress, Physiological Clinical Trial

Official title:

Internal Sources of Minority Stress and Alcohol Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091189
• Other study ID #: AA030373
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 10, 2023
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

Inclusion Criteria:

• Cisgender
• Age 21-29
• Sexual Identity Uncertainty (SIU; non-zero scores on a published measure). Among those with a zero level of SIU, only those who report sexual attractions and/or behaviors to both female and male partners (i.e., bisexual/bi+) will be invited to lab sessions.
• Scores on the Alcohol Use Disorders Identification Test (AUDIT) that indicate mild or moderate risk for potential alcohol use disorder

Exclusion Criteria:

• Alcohol naive persons (i.e., those without a history of alcohol use in their lifetime ).
• Female persons who are currently pregnant (established with urine pregnancy test) or actively trying to get pregnant (self-report in the screening survey).
• Persons who are currently in treatment or who have ever been in treatment for a substance use disorder.
• Persons who have essential medications that disallow the consumption of alcohol.
• 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,

Related Conditions & MeSH terms

• Alcohol Drinking
• Distress, Emotional
• Stress, Physiological

Intervention

Behavioral:
• Relevant Trier Social Stressor Test (TSST)
The Relevant TSST condition is a behavioral intervention that catalyzes an internalized stress response in the presence of a relevant social identity.

Drug:
• 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. None of the control (placebo) drinks will contain ethanol.

Behavioral:
• Placebo Trier Social Stressor Test (TSST)
The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.
• Placebo Beverage
Placebo drinks will not contain ethanol; Drinks given to participants in the placebo beverage condition will contain a mixer that does not contain ethanol.
• Irrelevant Trier Social Stressor Test (TSST)
The Irrelevant TSST condition is a behavioral intervention that functions as an alternative comparative condition, given no internalized stress response is expected in the presence of an irrelevant social identity.

Locations

Country	Name	City	State
United States	Texas Tech University	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

References & Publications (7)

de Wit H, Chutuape MA. Increased ethanol choice in social drinkers following ethanol preload. Behav Pharmacol. 1993 Feb;4(1):29-36. — View Citation

Het S, Rohleder N, Schoofs D, Kirschbaum C, Wolf OT. Neuroendocrine and psychometric evaluation of a placebo version of the 'Trier Social Stress Test'. Psychoneuroendocrinology. 2009 Aug;34(7):1075-86. doi: 10.1016/j.psyneuen.2009.02.008. — View Citation

Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004. — View Citation

Martin CS, Earleywine M, Musty RE, Perrine MW, Swift RM. Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res. 1993 Feb;17(1):140-6. doi: 10.1111/j.1530-0277.1993.tb00739.x. — View Citation

Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x. — View Citation

Talley AE, Stevens JE. Sexual Orientation Self-Concept Ambiguity: Scale Adaptation and Validation. Assessment. 2017 Jul;24(5):632-645. doi: 10.1177/1073191115617016. Epub 2015 Dec 7. — View Citation

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beverage Consumption (in mL)	Total beverage consumption in 35-minute tasting period.	35 minutes
Primary	Psychological Distress	Self-reported with the Positive and Negative Affective Schedule, measured on a 1 - 5 point scale, where higher numbers indicate more distress.	Five repeated assessments, at 15-minute intervals, in lab session, immediately following beverage consumption, until study completion (BrAC < .02%, an average of 60 minutes following consumption).
Primary	Salivary Stress Response	Amount of salivary cortisol (deciliter/mL)	Baseline (following consent procedures) = Time 0; 2nd Collection: 25 minutes after Time 0; 3rd collection: 55 minutes after Time 0; 4th collection: 85 minutes after Time 0; 5th collection: 115 minutes after Time 0.
Secondary	Perceived Intoxication	Self-reported with single, face-valid item as well as the biphasic alcohol effects scale, rated on a 0 to 10 point scale, where higher numbers indicate a greater level of perceived intoxication.	Five repeated assessments, at 15-minute intervals, in lab session, immediately following the taste-test portion of the study (beverage consumption), until study completion.
Secondary	Breath Alcohol Concentration	Assessed with Intoximeters Alco-Sensor FST Breathalyzer	Baseline measure to ensure adherence to pre-lab session protocols. Plus, 5 repeated assessments, at 15-minute intervals, in lab session, immediately following beverage consumption, until study completion (BrAC < .02%).
Secondary	Heart Rate	Heart rate will be assessed regularly as additional indicator of stress responses, and reported in beats per minute.	Baseline measure upon arrival to the lab session. Plus, 5 repeated assessments, at 15-minute intervals, in lab session, immediately following the taste-test portion of the study (beverage consumption), until study completion.
Secondary	Blood Pressure	Systolic and diastolic blood pressure will be assessed at baseline and five repeated intervals, as additional indicator of stress responses.	Baseline measure upon arrival to the lab session. Plus, 5 repeated assessments, at 15-minute intervals, in lab session, immediately following the taste-test portion of the study (beverage consumption), until study completion.