Internal Sources of Minority Stress and Alcohol Consumption
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Beverage Consumption (in mL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will not be informed of their assigned experimental condition until the debriefing occurs. Investigators will be blind to participants assigned experimental condition.
入排标准
- 年龄范围
- 21 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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,
研究组 & 干预措施
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.
干预措施: Relevant Trier Social Stressor Test (TSST) (Behavioral)
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.
干预措施: Placebo Beverage (Behavioral)
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.
干预措施: Placebo Beverage (Behavioral)
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.
干预措施: Irrelevant Trier Social Stressor Test (TSST) (Behavioral)
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.
干预措施: Placebo Trier Social Stressor Test (TSST) (Behavioral)
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.
干预措施: Placebo Beverage (Behavioral)
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.
干预措施: Relevant Trier Social Stressor Test (TSST) (Behavioral)
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.
干预措施: Ethanol (Drug)
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.
干预措施: Ethanol (Drug)
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.
干预措施: Irrelevant Trier Social Stressor Test (TSST) (Behavioral)
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.
干预措施: Ethanol (Drug)
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.
干预措施: Placebo Trier Social Stressor Test (TSST) (Behavioral)
结局指标
主要结局
Beverage Consumption (in mL)
时间窗: 35 minutes
Total beverage consumption in 35-minute tasting period.
Psychological Distress
时间窗: 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.
Salivary Stress Response
时间窗: 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)
次要结局
- 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.)
- 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.)
- 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.)
- 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%).)