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

Primary Purpose

Alcohol Drinking, Racism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol administration
Placebo
No Alcohol
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Drinking

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Moderate Alcohol

Low Alcohol

Placebo Alcohol

No Alcohol

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 7, 2019
Last Updated
November 10, 2021
Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03807817
Brief Title
Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
Official Title
Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Racism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate Alcohol
Arm Type
Experimental
Arm Title
Low Alcohol
Arm Type
Experimental
Arm Title
Placebo Alcohol
Arm Type
Active Comparator
Arm Title
No Alcohol
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Alcohol administration
Intervention Description
Amount of alcohol to be administered.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Alcohol
Intervention Type
Other
Intervention Name(s)
No Alcohol
Intervention Description
No Alcohol
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory, State Version (STAI-S)
Description
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.
Time Frame
5 minutes before alcohol administration, and 5 minutes after alcohol administration.
Title
Alcohol Urge Questionnaire (AUQ)
Description
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.
Time Frame
5 minutes before alcohol administration, and 5 minutes after alcohol administration.
Title
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)
Description
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.
Time Frame
5 minutes after participating in the stressor task.
Secondary Outcome Measure Information:
Title
Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale
Description
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.
Time Frame
5 minutes before alcohol administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andres G Viana, Ph.D
Phone
832-842-0234
Email
agviana@uh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres G Viana, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Viana
Phone
832-842-0234
Email
agviana@uh.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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