Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 28, 2024
February 1, 2024
4.3 years
January 7, 2019
February 23, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale
5 minutes before alcohol administration.
Study Arms (4)
Moderate Alcohol
EXPERIMENTALLow Alcohol
EXPERIMENTALPlacebo Alcohol
ACTIVE COMPARATORNo Alcohol
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years of age
- moderate or heavy drinker based on a past-month AUDIT score \>= 8.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Houston
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andres G Viana, Ph.D.
University of Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 17, 2019
Study Start
October 1, 2019
Primary Completion
December 31, 2023
Study Completion
January 31, 2024
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be made available 2 years after completion of the study.
- 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.
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.