Alcohol DrinkingNCT03807817
Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
A study testing Alcohol administration and No Alcohol in people with Alcohol Drinking and Racism, run by University of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Drinking, Racism
- What is being tested?
- Alcohol administration and No Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-65 years of age
- moderate or heavy drinker based on a past-month AUDIT score >= 8.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Drinking, Racism
- Being tested
- Alcohol administration, Placebo, No Alcohol
- Medical subject headings
- Alcohol Drinking, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol administrationOther
Amount of alcohol to be administered.
PlaceboOther
Placebo Alcohol
No AlcoholOther
No Alcohol
| Study group | Role | What they receive |
|---|---|---|
| Moderate Alcohol | Experimental | Not described Receives: Other: Alcohol administration |
| Low Alcohol | Experimental | Not described Receives: Other: Alcohol administration |
| Placebo Alcohol | Active comparator | Not described Receives: Other: Placebo |
| No Alcohol | Active comparator | Not described Receives: Other: No Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 minutes after participating in the stressor task.
Secondary outcomes (1)
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.
Measured: 5 minutes before alcohol administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Andres G. Viana, University of Houston
- Investigators
- Andres G Viana, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807817
- Sponsor's protocol ID
- 1K23AA025920-01A1
- Status last verified
- Feb 2024
- First submitted
- 7 Jan 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Mallin EL, Silva K, Amarneh DY, Cotton MR, Hernandez Ortiz J, Trent ES, Zvolensky MJ, Viana AG. Acculturative stress and internalizing problems among Latinos who drink hazardously: The roles of distress tolerance and emotion dysregulation. Exp Clin Psychopharmacol. 2026 May 4:10.1037/pha0000856. doi: 10.1037/pha0000856. Online ahead of print.
PubMed 42080858
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
- ClinicalTrials.gov ID
- NCT03807817
- Acronym / sponsor ID
- 1K23AA025920-01A1
- Conditions
- Alcohol Drinking, Racism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moderate Alcohol | Experimental | Other: Alcohol administration |
| Low Alcohol | Experimental | Other: Alcohol administration |
| Placebo Alcohol | Active comparator | Other: Placebo |
| No Alcohol | Active comparator | Other: No Alcohol |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 21-65 years of age
- moderate or heavy drinker based on a past-month AUDIT score >= 8.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol administrationAmount of alcohol to be administered. | Other | Low Alcohol, Moderate Alcohol |
| PlaceboPlacebo Alcohol | Other | Placebo Alcohol |
| No AlcoholNo Alcohol | Other | No Alcohol |
Primary outcome
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.
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.
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.
1 secondary outcome
Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale
Time frame: 5 minutes before alcohol administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 42080858Mallin EL, Silva K, Amarneh DY, Cotton MR, Hernandez Ortiz J, Trent ES, Zvolensky MJ, Viana AG. Acculturative stress and internalizing problems among Latinos who drink hazardously: The roles of distress tolerance and emotion dysregulation. Exp Clin Psychopharmacol. 2026 May 4:10.1037/pha0000856. doi: 10.1037/pha0000856. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andres G Viana, Ph.D. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol administration and No Alcohol in people with Alcohol Drinking and Racism, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory, State Version (STAI-S) (time frame: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.