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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807817
• Other study ID #: 1K23AA025920-01A1
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Racism

Intervention

Other:
• Alcohol administration
Amount of alcohol to be administered.
• Placebo
Placebo Alcohol
• No Alcohol
No Alcohol

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.