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Stress Tests for Stress-Related Alcohol Consumption

Phase < 1
Recruiting
Research Sponsored by Texas Tech University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cisgender
Age 21-29
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights

Study Summary

This trial looks into how internalized stress about one's sexual orientation affects heavy drinking and how alcohol consumption in turn affects psychological distress.

Who is the study for?
This trial is for cisgender adults aged 21-29 who are uncertain about their sexual orientation or identify as bisexual/bi+, and have mild to moderate risk of alcohol use disorder. It excludes those with no history of alcohol use, pregnant women, individuals in substance abuse treatment, on certain medications, or at high risk for alcohol use disorder.Check my eligibility
What is being tested?
The study tests how internalized stress related to sexual orientation uncertainty affects heavy drinking behavior. Participants will be exposed to different stress tests and given either ethanol or a placebo beverage to see if this influences their subsequent alcohol consumption.See study design
What are the potential side effects?
Potential side effects from consuming ethanol include intoxication symptoms like dizziness, nausea, impaired coordination and judgment. Psychological distress may also occur due to the nature of the stress tests involved in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I identify with the gender I was assigned at birth.
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I am between 21 and 29 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beverage Consumption (in mL)
Psychological Distress
Salivary Stress Response
Secondary outcome measures
Blood Pressure
Breath Alcohol Concentration
Heart Rate
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Relevant Stressor Condition with No EthanolExperimental Treatment2 Interventions
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.
Group II: Relevant Stressor Condition with EthanolExperimental Treatment2 Interventions
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.
Group III: Irrelevant Stressor Condition with No EthanolActive Control2 Interventions
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.
Group IV: Irrelevant Stressor Condition with EthanolActive Control2 Interventions
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.
Group V: Control Stressor Condition with EthanolPlacebo Group2 Interventions
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.
Group VI: Control Stressor Condition with No EthanolPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
2005
Completed Phase 4
~3000
Placebo Beverage
2016
Completed Phase 2
~190

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Who is running the clinical trial?

Texas Tech UniversityLead Sponsor
81 Previous Clinical Trials
8,964 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the desired outcome of this investigation?

"This 35-minute trial is designed to measure Psychological Distress as its primary objective. As secondary goals, the study will calculate Breath Alcohol Concentration using Alco-Sensor FST Breathalyzers, Heart Rate by recording beats per minute, and Blood Pressure through systolic and diastolic measurements."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Internalized Stress in Relation to Alcohol Consumption
2023. "Internalized Stress in Relation to Alcohol Consumption". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091189.
~133 spots leftby May 2025
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