Internalized Stress in Relation to Alcohol Consumption

Texas Tech University

Status and phase: Terminated; Early Phase 1

Conditions: Stress, Physiological; Distress, Emotional; Ethanol Intoxication

Treatments: Behavioral: Placebo Beverage; Behavioral: Relevant Trier Social Stressor Test (TSST); Drug: Ethanol; Behavioral: Irrelevant Trier Social Stressor Test (TSST); Behavioral: Placebo Trier Social Stressor Test (TSST)

Study type: Interventional

Funder types: Other

Identifiers

NCT06091189

AA030373

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 21 to 29 years old

Volunteers: Accepts 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,

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

165 participants in 6 patient groups, including a placebo group

Relevant Stressor Condition with No Ethanol

Experimental group

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.

Treatment:

Behavioral: Relevant Trier Social Stressor Test (TSST)

Behavioral: Placebo Beverage

Irrelevant Stressor Condition with No Ethanol

Active Comparator group

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.

Treatment:

Behavioral: Irrelevant Trier Social Stressor Test (TSST)

Behavioral: Placebo Beverage

Control Stressor Condition with No Ethanol

Placebo Comparator group

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.

Treatment:

Behavioral: Placebo Trier Social Stressor Test (TSST)

Behavioral: Placebo Beverage

Relevant Stressor Condition with Ethanol

Experimental group

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.

Treatment:

Drug: Ethanol

Behavioral: Relevant Trier Social Stressor Test (TSST)

Irrelevant Stressor Condition with Ethanol

Active Comparator group

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.

Treatment:

Behavioral: Irrelevant Trier Social Stressor Test (TSST)

Drug: Ethanol

Control Stressor Condition with Ethanol

Placebo Comparator group

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.

Treatment:

Behavioral: Placebo Trier Social Stressor Test (TSST)

Drug: Ethanol