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临床试验/NCT03807817
NCT03807817已完成不适用

Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms

University of Houston2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
State-Trait Anxiety Inventory, State Version (STAI-S)

研究概览

简要总结

The purpose of this study is to examine the pharmacological effects of alcohol on acute anxiety levels in a sample of Latino drinkers, and cultural experiences influencing these relationships.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21-65 years of age
  • moderate or heavy drinker based on a past-month AUDIT score >= 8.

排除标准

  • Possibility of being pregnant (verified by urine sample);
  • Self-reported history of or treatment for alcohol/other drug problems (as required by the IRB in past human alcohol administration research);
  • Moderate risk for drug problems as indicated by SMAST scores ≥ 5 or ASSIST scores of ≥ 4 (see Measures);
  • Medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease);
  • Current use of psychiatric meds or any meds with alcohol contraindication (e.g., antibiotics);
  • Current non-alcohol substance use disorder;
  • Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.

结局指标

主要结局

State-Trait Anxiety Inventory, State Version (STAI-S)

时间窗: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.

The State-Trait Anxiety Inventory, State Version (STAI-S) is a 20-item self-report questionnaire which assesses state (i.e., current) anxiety. Participants are asked to rate the frequency with which they experience a variety of anxiety symptoms (e.g., "I feel nervous and restless") on a 4-point scale (1 = almost never to 4 = almost always). Total scores (range = 20-80) are computed by summing individual item scores; higher scores indicate higher state anxiety. The State-Trait Anxiety Inventory, State Version (STAI-S) will be used to measure manifest anxiety among participants 5 minutes before, and 5 minutes after, the alcohol administration. We will specifically measure changes in manifest anxiety from pre- to post-alcohol administration by subtracting the participant's score on the STAI-S after the alcohol administration from the participant's score on the STAI-S before the alcohol administration.

Alcohol Urge Questionnaire (AUQ)

时间窗: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.

Urge to drink will be measured using the internally consistent, reliable, and well-validated Alcohol Urge Questionnaire (AUQ), an 8-item measure of state (current) urge to drink alcohol. Items are rated on a 7-point scale from 1 = "strongly disagree" to 7 = "strongly agree." A total score is computed by adding responses to each of the items. Higher scores indicate a stronger urge to drink. The Alcohol Urge Questionnaire (AUQ) will be used to measure urge to drink among participants at 5 minutes before, and 5 minutes after, the alcohol administration. We will specifically measure changes in urge to drink from pre- to post-alcohol administration by subtracting the participant's score on the AUQ post-alcohol administration from the participant's score on the AUQ pre-alcohol administration.

Amount of alcohol consumed in "standard drinks" (0.6 oz. ethanol equivalents, 12 oz. U.S. domestic beer, 5 oz. 12% alcohol table wine, 1.5 oz. 80-proof hard liquor)

时间窗: 5 minutes after participating in the stressor task.

Amount of alcohol consumed in "standard drinks" (0.6 oz. ethanol equivalents, 12 oz. U.S. domestic beer, 5 oz. 12% alcohol table wine, 1.5 oz. 80-proof hard liquor) will be estimated for each participant.

次要结局

  • Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale(5 minutes before alcohol administration.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres G. Viana

Assistant Professor

University of Houston

研究点 (2)

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