Internalized Stress in Relation to Alcohol Consumption

May 5, 2025 updated by: Texas Tech University

Internal Sources of Minority Stress and Alcohol Consumption

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79409
        • Texas Tech University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Relevant Stressor Condition with No 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 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
Placebo drinks will not contain ethanol; Drinks given to participants in the placebo beverage condition will contain a mixer that does not contain ethanol.
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.
Active Comparator: Irrelevant Stressor Condition with No 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.
Behavioral: 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.
Behavioral: 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.
Placebo Comparator: Control Stressor Condition with No 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.
Behavioral: 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.
Behavioral: Placebo Trier Social Stressor Test (TSST)
The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.
Experimental: Relevant Stressor Condition with 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.
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: 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.
Active Comparator: Irrelevant Stressor Condition with 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.
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: 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.
Placebo Comparator: Control Stressor Condition with 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.
Behavioral: Placebo Trier Social Stressor Test (TSST)
The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beverage Consumption (in mL)
Time Frame: 35 minutes
Total beverage consumption in 35-minute tasting period.
35 minutes
Psychological 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).
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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%).
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AA030373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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