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Completed

NCT Number: NCT03807817

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.

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Prejudice Racism Social Behavior Social Discrimination

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston

Houston, Texas, 77204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alcohol Administration

Other

Amount of alcohol to be administered.

Placebo

Other

Placebo Alcohol

No Alcohol

Other

No Alcohol

Primary outcomes

  1. State-Trait Anxiety Inventory, State Version (STAI-S)

    Time frame: 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.

  2. Alcohol Urge Questionnaire (AUQ)

    Time frame: 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.

  3. 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)

    Time frame: 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 outcomes

  1. Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Jan 17, 2019
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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