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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Drinking, Racism

Intervention / Treatment
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* Other: Alcohol administration
* Other: Placebo
* Other: No Alcohol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21-65 years of age moderate or heavy drinker based on a past-month AUDIT score >= 8. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Alcohol<br> | Other: Alcohol administration<br>* Amount of alcohol to be administered.<br>|
| Experimental: Low Alcohol<br> | Other: Alcohol administration<br>* Amount of alcohol to be administered.<br>|
| Active Comparator: Placebo Alcohol<br> | Other: Placebo<br>* Placebo Alcohol<br>|
| Active Comparator: No Alcohol<br> | Other: No Alcohol<br>* No Alcohol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory, State Version (STAI-S) | 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. | 5 minutes before alcohol administration, and 5 minutes after alcohol administration. | 
| Alcohol Urge Questionnaire (AUQ) | 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. | 5 minutes before alcohol administration, and 5 minutes after 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) | 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. | 5 minutes after participating in the stressor task. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale | We will examine participants' Substance Use Attitudes and Expectancies 5 minutes before the intervention using Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale. The scale contains 12 items, rated from 1 = definitely no to 4 = definitely yes. Total scores are computed by averaging responses across items. Higher scores indicate more frequent pro-drug attitudes. | 5 minutes before alcohol administration. |