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Internalized Stress in Relation to Alcohol Consumption

Primary Purpose

Stress, Physiological, Ethanol Intoxication, Distress, Emotional

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Relevant Trier Social Stressor Test (TSST)
Ethanol
Placebo Trier Social Stressor Test (TSST)
Placebo Beverage
Irrelevant Trier Social Stressor Test (TSST)
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress, Physiological

Eligibility Criteria

21 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Texas Tech University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

Relevant Stressor Condition with No Ethanol

Irrelevant Stressor Condition with No Ethanol

Control Stressor Condition with No Ethanol

Relevant Stressor Condition with Ethanol

Irrelevant Stressor Condition with Ethanol

Control Stressor Condition with Ethanol

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Beverage Consumption (in mL)
Total beverage consumption in 35-minute tasting period.
Psychological Distress
Self-reported with the Positive and Negative Affective Schedule, measured on a 1 - 5 point scale, where higher numbers indicate more distress.
Salivary Stress Response
Amount of salivary cortisol (deciliter/mL)

Secondary Outcome Measures

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.
Breath Alcohol Concentration
Assessed with Intoximeters Alco-Sensor FST Breathalyzer
Heart Rate
Heart rate will be assessed regularly as additional indicator of stress responses, and reported in beats per minute.
Blood Pressure
Systolic and diastolic blood pressure will be assessed at baseline and five repeated intervals, as additional indicator of stress responses.

Full Information

First Posted
September 22, 2023
Last Updated
October 19, 2023
Sponsor
Texas Tech University
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1. Study Identification

Unique Protocol Identification Number
NCT06091189
Brief Title
Internalized Stress in Relation to Alcohol Consumption
Official Title
Internal Sources of Minority Stress and Alcohol Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Physiological, Ethanol Intoxication, Distress, Emotional

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Masking Description
Participants will not be informed of their assigned experimental condition until the debriefing occurs. Investigators will be blind to participants assigned experimental condition.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relevant Stressor Condition with No Ethanol
Arm Type
Experimental
Arm Description
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.
Arm Title
Irrelevant Stressor Condition with No Ethanol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Stressor Condition with No Ethanol
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Relevant Stressor Condition with Ethanol
Arm Type
Experimental
Arm Description
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.
Arm Title
Irrelevant Stressor Condition with Ethanol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Stressor Condition with Ethanol
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relevant Trier Social Stressor Test (TSST)
Intervention Description
The Relevant TSST condition is a behavioral intervention that catalyzes an internalized stress response in the presence of a relevant social identity.
Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Trier Social Stressor Test (TSST)
Intervention Description
The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Beverage
Intervention Description
Placebo drinks will not contain ethanol; Drinks given to participants in the placebo beverage condition will contain a mixer that does not contain ethanol.
Intervention Type
Behavioral
Intervention Name(s)
Irrelevant Trier Social Stressor Test (TSST)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beverage Consumption (in mL)
Description
Total beverage consumption in 35-minute tasting period.
Time Frame
35 minutes
Title
Psychological Distress
Description
Self-reported with the Positive and Negative Affective Schedule, measured on a 1 - 5 point scale, where higher numbers indicate more distress.
Time Frame
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).
Title
Salivary Stress Response
Description
Amount of salivary cortisol (deciliter/mL)
Time Frame
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 Measure Information:
Title
Perceived Intoxication
Description
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.
Time Frame
Five repeated assessments, at 15-minute intervals, in lab session, immediately following the taste-test portion of the study (beverage consumption), until study completion.
Title
Breath Alcohol Concentration
Description
Assessed with Intoximeters Alco-Sensor FST Breathalyzer
Time Frame
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%).
Title
Heart Rate
Description
Heart rate will be assessed regularly as additional indicator of stress responses, and reported in beats per minute.
Time Frame
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.
Title
Blood Pressure
Description
Systolic and diastolic blood pressure will be assessed at baseline and five repeated intervals, as additional indicator of stress responses.
Time Frame
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.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Cisgender
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CassiDe Street, PhD
Phone
806-742-2064
Email
hrpp@ttu.edu
First Name & Middle Initial & Last Name & Degree
Amelia E Talley, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators will plan to share IPD with identifying information removed.
IPD Sharing Time Frame
Within 6 months of end of the granting period
IPD Sharing Access Criteria
Requestor must adequately describe a research-related need to access the data. Requestor must be associated with an NIH-recognized research institution, defined as an institution registered in the NIH electronic research administration system (eRA Commons,) and have the approval of an authorized signatory official of that institution. Requestor's institution must have an active Federal wide Assurance (FWA.)
IPD Sharing URL
https://nda.nih.gov/niaaa/
Citations:
PubMed Identifier
8255414
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.
Results Reference
background
PubMed Identifier
19307062
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.
Results Reference
background
PubMed Identifier
11224168
Citation
de Wit H, Chutuape MA. Increased ethanol choice in social drinkers following ethanol preload. Behav Pharmacol. 1993 Feb;4(1):29-36.
Results Reference
background
PubMed Identifier
8452195
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.
Results Reference
background
PubMed Identifier
26643117
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.
Results Reference
background
PubMed Identifier
8329970
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.
Results Reference
background
PubMed Identifier
3397865
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.
Results Reference
background

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Internalized Stress in Relation to Alcohol Consumption

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