<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03807817</url>
  </required_header>
  <id_info>
    <org_study_id>1K23AA025920-01A1</org_study_id>
    <nct_id>NCT03807817</nct_id>
  </id_info>
  <brief_title>Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms</brief_title>
  <official_title>Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the pharmacological effects of alcohol on acute&#xD;
      anxiety levels in a sample of Latino drinkers, and cultural experiences influencing these&#xD;
      relationships.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>State-Trait Anxiety Inventory, State Version (STAI-S)</measure>
    <time_frame>5 minutes before alcohol administration, and 5 minutes after alcohol administration.</time_frame>
    <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., &quot;I feel nervous and restless&quot;) 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.&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol Urge Questionnaire (AUQ)</measure>
    <time_frame>5 minutes before alcohol administration, and 5 minutes after alcohol administration.</time_frame>
    <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 = &quot;strongly disagree&quot; to 7 = &quot;strongly agree.&quot; A total score is computed by adding responses to each of the items. Higher scores indicate a stronger urge to drink.&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of alcohol consumed in &quot;standard drinks&quot; (0.6 oz. ethanol equivalents, 12 oz. U.S. domestic beer, 5 oz. 12% alcohol table wine, 1.5 oz. 80-proof hard liquor)</measure>
    <time_frame>5 minutes after participating in the stressor task.</time_frame>
    <description>Amount of alcohol consumed in &quot;standard drinks&quot; (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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kulis, Marsiglia &amp; Nieri's (2009) Substance Use Attitudes/Expectancies Scale</measure>
    <time_frame>5 minutes before alcohol administration.</time_frame>
    <description>We will examine participants' Substance Use Attitudes and Expectancies 5 minutes before the intervention using Kulis, Marsiglia &amp; Nieri's (2009) Substance Use Attitudes/Expectancies Scale. The scale contains 12 items, rated from 1 = &quot;definitely no&quot; to 4 = &quot;definitely yes.&quot; Total scores are computed by averaging responses across items. Higher scores indicate more frequent pro-drug attitudes.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Alcohol Drinking</condition>
  <condition>Racism</condition>
  <arm_group>
    <arm_group_label>Moderate Alcohol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Alcohol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Alcohol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No Alcohol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alcohol administration</intervention_name>
    <description>Amount of alcohol to be administered.</description>
    <arm_group_label>Low Alcohol</arm_group_label>
    <arm_group_label>Moderate Alcohol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Alcohol</description>
    <arm_group_label>Placebo Alcohol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Alcohol</intervention_name>
    <description>No Alcohol</description>
    <arm_group_label>No Alcohol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 21-65 years of age&#xD;
&#xD;
          2. moderate or heavy drinker based on a past-month AUDIT score &gt;= 8.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Possibility of being pregnant (verified by urine sample);&#xD;
&#xD;
          2. Self-reported history of or treatment for alcohol/other drug problems (as required by&#xD;
             the IRB in past human alcohol administration research);&#xD;
&#xD;
          3. Moderate risk for drug problems as indicated by SMAST scores ≥ 5 or ASSIST scores of ≥&#xD;
             4 (see Measures);&#xD;
&#xD;
          4. Medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver&#xD;
             disease);&#xD;
&#xD;
          5. Current use of psychiatric meds or any meds with alcohol contraindication (e.g.,&#xD;
             antibiotics);&#xD;
&#xD;
          6. Current non-alcohol substance use disorder;&#xD;
&#xD;
          7. Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current&#xD;
             psychosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres G Viana, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andres G Viana, Ph.D</last_name>
    <phone>832-842-0234</phone>
    <email>agviana@uh.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andres Viana</last_name>
      <phone>832-842-0234</phone>
      <email>agviana@uh.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 10, 2021</last_update_submitted>
  <last_update_submitted_qc>November 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Houston</investigator_affiliation>
    <investigator_full_name>Andres G. Viana</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be made available 2 years after completion of the study.</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03807817
org study id: 1K23AA025920-01A1
nct id: NCT03807817
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: State-Trait Anxiety Inventory, State Version (STAI-S)
time frame: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.
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.
measure: Alcohol Urge Questionnaire (AUQ)
time frame: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.
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.
measure: 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.
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.
measure: Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale
time frame: 5 minutes before alcohol administration.
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.
arm group label: Moderate Alcohol
arm group type: Experimental
arm group label: Low Alcohol
arm group type: Experimental
arm group label: Placebo Alcohol
arm group type: Active Comparator
arm group label: No Alcohol
arm group type: Active Comparator
intervention type: Other
intervention name: Alcohol administration
description: Amount of alcohol to be administered.
arm group label: Low Alcohol
arm group label: Moderate Alcohol
intervention type: Other
intervention name: Placebo
description: Placebo Alcohol
arm group label: Placebo Alcohol
intervention type: Other
intervention name: No Alcohol
description: No Alcohol
arm group label: No Alcohol
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andres G Viana, Ph.D.
role: Principal Investigator
affiliation: University of Houston
last name: Andres G Viana, Ph.D
phone: 832-842-0234
email: agviana@uh.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Houston
investigator full name: Andres G. Viana
investigator title: Assistant Professor
mesh term: Alcohol Drinking
mesh term: Ethanol
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be made available 2 years after completion of the study.
ipd 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.