Internalized Stress in Relation to Alcohol Consumption

Study Overview
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Brief Summary
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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.

Official Title
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Internal Sources of Minority Stress and Alcohol Consumption

Conditions
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Stress, Physiological, Ethanol Intoxication, Distress, Emotional

Intervention / Treatment
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* Behavioral: Relevant Trier Social Stressor Test (TSST)
* Drug: Ethanol
* Behavioral: Placebo Trier Social Stressor Test (TSST)
* Behavioral: Placebo Beverage
* Behavioral: Irrelevant Trier Social Stressor Test (TSST)


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relevant Stressor Condition with No Ethanol<br>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. | Behavioral: Relevant Trier Social Stressor Test (TSST)<br>* The Relevant TSST condition is a behavioral intervention that catalyzes an internalized stress response in the presence of a relevant social identity.<br>Behavioral: Placebo Beverage<br>* Placebo drinks will not contain ethanol; Drinks given to participants in the placebo beverage condition will contain a mixer that does not contain ethanol.<br>|
| Active Comparator: Irrelevant Stressor Condition with No Ethanol<br>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. | Behavioral: Placebo Beverage<br>* Placebo drinks will not contain ethanol; Drinks given to participants in the placebo beverage condition will contain a mixer that does not contain ethanol.<br>Behavioral: Irrelevant Trier Social Stressor Test (TSST)<br>* 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.<br>|
| Placebo Comparator: Control Stressor Condition with No Ethanol<br>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. | Behavioral: Placebo Trier Social Stressor Test (TSST)<br>* The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.<br>Behavioral: Placebo Beverage<br>* Placebo drinks will not contain ethanol; Drinks given to participants in the placebo beverage condition will contain a mixer that does not contain ethanol.<br>|
| Experimental: Relevant Stressor Condition with Ethanol<br>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. | Behavioral: Relevant Trier Social Stressor Test (TSST)<br>* The Relevant TSST condition is a behavioral intervention that catalyzes an internalized stress response in the presence of a relevant social identity.<br>Drug: Ethanol<br>* 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.<br>|
| Active Comparator: Irrelevant Stressor Condition with Ethanol<br>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. | Drug: Ethanol<br>* 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.<br>Behavioral: Irrelevant Trier Social Stressor Test (TSST)<br>* 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.<br>|
| Placebo Comparator: Control Stressor Condition with Ethanol<br>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. | Drug: Ethanol<br>* 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.<br>Behavioral: Placebo Trier Social Stressor Test (TSST)<br>* The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beverage Consumption (in mL) | Total beverage consumption in 35-minute tasting period. | 35 minutes | 
| 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). | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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%). | 
| 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. | 
| 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. |