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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Racism
• Intervention / Treatment: Other: Alcohol administration; Other: Placebo; Other: No Alcohol

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Alcohol	Other: Alcohol administration; Amount of alcohol to be administered.
Experimental: Low Alcohol	Other: Alcohol administration; Amount of alcohol to be administered.
Active Comparator: Placebo Alcohol	Other: Placebo; Placebo Alcohol
Active Comparator: No Alcohol	Other: No Alcohol; No Alcohol

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Andres G Viana, Ph.D., University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: 1K23AA025920-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be released directly by the investigators provided that those requesting the data can provide proof of their institution's IRB approval for planned analyses of the data. The investigator's team will be available to address queries.
• IPD Sharing Time Frame: Data will be made available 2 years after completion of the study.
• IPD Sharing Access Criteria: We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be released directly by the investigators provided that those requesting the data can provide proof of their institution's IRB approval for planned analyses of the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No