Alcohol Drinking Clinical Trial
Official title:
Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
Verified date | February 2024 |
Source | University of Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Houston | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. |
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