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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807817
Enrollment
99
Registered
2019-01-17
Start date
2019-10-01
Completion date
2024-01-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Racism

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.

Interventions

Amount of alcohol to be administered.

OTHERPlacebo

Placebo Alcohol

No Alcohol

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
State-Trait Anxiety Inventory, State Version (STAI-S)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.
Alcohol Urge Questionnaire (AUQ)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.
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)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

MeasureTime frameDescription
Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale5 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026