Internalized Stress in Relation to Alcohol Consumption

Sponsor
Texas Tech University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06091189
Collaborator
(none)
200
1
6
20
10

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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)
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Participant, Investigator)
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.
Primary Purpose:
Basic Science
Official Title:
Internal Sources of Minority Stress and Alcohol Consumption
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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: 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.

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.

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 Trier Social Stressor Test (TSST)
The Placebo TSST is an established behavioral intervention that does not prompt significant stress responses.

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.

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Beverage Consumption (in mL) [35 minutes]

    Total beverage consumption in 35-minute tasting period.

  2. Psychological 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).]

    Self-reported with the Positive and Negative Affective Schedule, measured on a 1 - 5 point scale, where higher numbers indicate more distress.

  3. Salivary Stress Response [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)

Secondary Outcome Measures

  1. 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.]

    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.

  2. Breath Alcohol Concentration [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

  3. Heart Rate [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.

  4. Blood Pressure [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Tech University Lubbock Texas United States 79409

Sponsors and Collaborators

  • Texas Tech University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Texas Tech University
ClinicalTrials.gov Identifier:
NCT06091189
Other Study ID Numbers:
  • AA030373
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023