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

Not Applicable

Completed

• Conditions: Racism; Alcohol Drinking
• Interventions: Other: Placebo; Other: No Alcohol; Other: Alcohol administration

• Registration Number: NCT03807817
• Lead Sponsor: University of Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-17
• Study Start: 2019-10-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. 21-65 years of age
2. moderate or heavy drinker based on a past-month AUDIT score >= 8.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Alcohol	Placebo	-
No Alcohol	No Alcohol	-
Moderate Alcohol	Alcohol administration	-
Low Alcohol	Alcohol administration	-

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory, State Version (STAI-S)	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)	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)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Houston; 🇺🇸 Houston, Texas, United States