xml: <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/NCT05999344</url>
    </required_header>
    <id_info>
      <org_study_id>2161</org_study_id>
      <nct_id>NCT05999344</nct_id>
    </id_info>
    <brief_title>Alcohol and Cannabis Concentrates Co-Administration</brief_title>
    <official_title>Exploring Intoxication During Acute Alcohol and Cannabis Concentrate Co-Administration: A Focus on Cannabinoid Content and Order Effects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Colorado State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institute of Cannabis Research (ICR)--Colorado State University, Pueblo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Colorado State University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to learn about the effects of combining alcohol with cannabis&#xD;
        concentrate products which contain high levels of THC. The main question[s] it aims to answer&#xD;
        are, 1) How does the order in which someone consumes THC and alcohol in a given co-use&#xD;
        session impact outcomes such as blood alcohol level, heart rate or subjective drug effects,&#xD;
        and 2) how does THC percentage in cannabis influence outcomes following alcohol and cannabis&#xD;
        co-administration. Participants will be scheduled for our mobile lab to come to their&#xD;
        residence. During the session, they will:&#xD;
  &#xD;
          -  consume a standardized dose of alcohol as well as use their own preferred cannabis&#xD;
             concentrate product.&#xD;
  &#xD;
          -  they will then remain in our mobile lab for about 4 hours and complete some surveys as&#xD;
             well as do some cognitive tasks on an iPad every 30 minutes.&#xD;
  &#xD;
          -  They will also have their blood drawn three times throughout the session, and will&#xD;
             periodically be asked to blood into a breathalyzer to measure blood alcohol level.&#xD;
  &#xD;
        Researchers will compare people who use alcohol prior to cannabis to those who use cannabis&#xD;
        prior to alcohol to determine whether order of use impacts outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Individuals who drink alcohol commonly report co-using cannabis, and the increasing&#xD;
        availability of new formulations of highly potent cannabis products on the legal market means&#xD;
        that alcohol is likely being combined with cannabis products that contain high levels of&#xD;
        delta-9-tetrahydrocannabinol (THC). There is limited existing research on the acute effects&#xD;
        of cannabis products containing high amounts of THC, such as cannabis concentrates, which&#xD;
        often contain up to 90% THC. Existing laboratory data suggests that consuming alcohol and&#xD;
        cannabis together (compared to alcohol alone) is associated with reduced BAC, delayed time to&#xD;
        peak blood alcohol concentration (BAC), longer duration of intoxication, and increased&#xD;
        subjective intoxication, but it is unknown how cannabis concentrates may interact with&#xD;
        alcohol to influence these outcomes. There is also a lack of research regarding whether&#xD;
        timing or order of use matters, though recent survey data from our group and others suggests&#xD;
        that using alcohol before cannabis may confer additional risk compared to using cannabis&#xD;
        prior to alcohol. The present study leverages a federally-compliant mobile laboratory design&#xD;
        to explore the acute effects of self-administered cannabis concentrates alongside a&#xD;
        standardized dose of alcohol. The investigators will recruit a community sample of&#xD;
        individuals who regularly use alcohol and cannabis to participate study sessions in our&#xD;
        mobile laboratory. The sessions will involve individuals consuming cannabis concentrates of&#xD;
        their choice (that they acquire themselves) along with a standardized dose of alcohol. Half&#xD;
        of the participants will use the alcohol before cannabis, and the other half will use the&#xD;
        cannabis before alcohol. The investigators will measure intoxication and biological outcomes&#xD;
        every 30 minutes for 4 hours. The investigators will also measure differences between those&#xD;
        who used alcohol before cannabis and those who used cannabis before alcohol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 16, 2021</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single group, randomized order of administration</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Breath Alcohol Level (BrAC)</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Alcohol Urge Questionnaire (AUQ)</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart Rate (HR)</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>Heart rate (beats per minute) is measured using a finger pulse oximeter</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ARCI Marijuana Scale</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>The ARCI scale measures subjective responses to cannabis. total score ranges from 0-12 where higher is worse</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DRUID Psychomotor Battery</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>The DRUID is a mobile app that tests for cognitive and motor impairment, and has been shown to detect impairment related to alcohol and cannabis use. total score ranges from 0-100 where higher is worse.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood-THC</measure>
      <time_frame>Blood is drawn immediately prior to alcohol and cannabis consumption, again 60 minutes post alcohol administration start time, and again 240 minutes post alcohol start time</time_frame>
      <description>We will quantify levels of THC in the blood before and after the participant uses their cannabis product</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biphasic Effects of Alcohol Scale (BAES)</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>The BAES measures the stimulating and sedating effects of alcohol and is validated for use in laboratory settings. This scale produces a stimulation subscale (total score ranges from 0-70 where higher is more stimulated) and a sedation subscale (total score ranging from 0-70 where higher is more sedated)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Profile of Mood States (POMS)</measure>
      <time_frame>Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)</time_frame>
      <description>The POMS is a self-report rating scale that assesses state-level, distinct mood states. The POMS produces multiple subscales (Tension, depression, anger, fatigue, confusion, vigour, as well as a total mood disturbance scale)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Alcohol Use Disorder</condition>
    <condition>Cannabis Use</condition>
    <arm_group>
      <arm_group_label>Alcohol + Cannabis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants are randomly assigned to receive the standardized alcohol dose during the experimental session prior to going inside their residence to self-administer their preferred cannabis concentrate product or randomly assigned to going inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose.&#xD;
  All participants receive alcohol and cannabis, however, the order of ingestion is randomly assigned.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>commercially available cannabis and commercially available alcohol</intervention_name>
      <description>Self administration of cannabis and researcher administered alcohol</description>
      <arm_group_label>Alcohol + Cannabis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 21-65 years old,&#xD;
  &#xD;
            2. Heavy drinkers (for men, &gt;4 drinks in one occasion, or &gt;14 drinks per week; for women,&#xD;
               &gt;3 drinks in one occasion, or &gt;7 drinks per week)&#xD;
  &#xD;
            3. Regular users of legal-market cannabis (at least 3x/week in past 3 months)&#xD;
  &#xD;
            4. Have experience using cannabis concentrates within the last year&#xD;
  &#xD;
            5. Willing to obtain a concentrate product of their choice for use in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance&#xD;
               use disorder (SUD)&#xD;
  &#xD;
            2. Pregnant, breastfeeding or trying to become pregnant&#xD;
  &#xD;
            3. Meet criteria for psychotic, bipolar or major depressive disorder with suicidal&#xD;
               ideation, or history of these disorders&#xD;
  &#xD;
            4. Current use of psychotropic (except anti-depressants) or steroid medications&#xD;
  &#xD;
            5. Report illicit drug use in past 60-days or fail drug screen (drug screen tests for the&#xD;
               presence of amphetamines, benzodiazepines, cocaine, THC, methamphetamine and opioids;&#xD;
               only THC is allowed to be present in urine in order to be eligible to participate in&#xD;
               the study&#xD;
  &#xD;
            6. Major medical condition contraindicating alcohol and/or cannabis consumption (e.g.,&#xD;
               liver disease, heart disease, or being told by a doctor that it is unsafe to consume&#xD;
               alcohol or cannabis due to a medical condition)&#xD;
  &#xD;
            7. Have participated in another research study in the past 8 weeks.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hollis C Karoly, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Colorado State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hollis C Karoly, PhD</last_name>
      <phone>970-491-3677</phone>
      <email>hollis.karoly@colostate.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Colorado State University</name>
        <address>
          <city>Fort Collins</city>
          <state>Colorado</state>
          <zip>80523</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hollis C. Karoly, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Hollis C. Karoly, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>alcohol</keyword>
    <keyword>cannabis</keyword>
    <keyword>polysubstance use</keyword>
    <keyword>psychomotor impairment</keyword>
    <keyword>cannabis concentrates</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Marijuana Abuse</mesh_term>
      <mesh_term>Alcoholism</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999344
  org study id: 2161
  nct id: NCT05999344
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this study is to learn about the effects of combining alcohol with cannabis
        concentrate products which contain high levels of THC. The main question[s] it aims to answer
        are, 1) How does the order in which someone consumes THC and alcohol in a given co-use
        session impact outcomes such as blood alcohol level, heart rate or subjective drug effects,
        and 2) how does THC percentage in cannabis influence outcomes following alcohol and cannabis
        co-administration. Participants will be scheduled for our mobile lab to come to their
        residence. During the session, they will:
  
          -  consume a standardized dose of alcohol as well as use their own preferred cannabis
             concentrate product.
  
          -  they will then remain in our mobile lab for about 4 hours and complete some surveys as
             well as do some cognitive tasks on an iPad every 30 minutes.
  
          -  They will also have their blood drawn three times throughout the session, and will
             periodically be asked to blood into a breathalyzer to measure blood alcohol level.
  
        Researchers will compare people who use alcohol prior to cannabis to those who use cannabis
        prior to alcohol to determine whether order of use impacts outcomes.
  Individuals who drink alcohol commonly report co-using cannabis, and the increasing
        availability of new formulations of highly potent cannabis products on the legal market means
        that alcohol is likely being combined with cannabis products that contain high levels of
        delta-9-tetrahydrocannabinol (THC). There is limited existing research on the acute effects
        of cannabis products containing high amounts of THC, such as cannabis concentrates, which
        often contain up to 90% THC. Existing laboratory data suggests that consuming alcohol and
        cannabis together (compared to alcohol alone) is associated with reduced BAC, delayed time to
        peak blood alcohol concentration (BAC), longer duration of intoxication, and increased
        subjective intoxication, but it is unknown how cannabis concentrates may interact with
        alcohol to influence these outcomes. There is also a lack of research regarding whether
        timing or order of use matters, though recent survey data from our group and others suggests
        that using alcohol before cannabis may confer additional risk compared to using cannabis
        prior to alcohol. The present study leverages a federally-compliant mobile laboratory design
        to explore the acute effects of self-administered cannabis concentrates alongside a
        standardized dose of alcohol. The investigators will recruit a community sample of
        individuals who regularly use alcohol and cannabis to participate study sessions in our
        mobile laboratory. The sessions will involve individuals consuming cannabis concentrates of
        their choice (that they acquire themselves) along with a standardized dose of alcohol. Half
        of the participants will use the alcohol before cannabis, and the other half will use the
        cannabis before alcohol. The investigators will measure intoxication and biological outcomes
        every 30 minutes for 4 hours. The investigators will also measure differences between those
        who used alcohol before cannabis and those who used cannabis before alcohol.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group, randomized order of administration
  primary purpose: Other
  masking: None (Open Label)
  measure: Breath Alcohol Level (BrAC)
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: Breath alcohol level will be measured using a breathalyzer repeatedly during the experimental session
  measure: Alcohol Urge Questionnaire (AUQ)
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: The AUQ is a self-report measure of urge for alcohol and has been validated for real-time assessment of alcohol craving in the laboratory. The total score on the measure ranges from 0-48 where higher is worse
  measure: Heart Rate (HR)
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: Heart rate (beats per minute) is measured using a finger pulse oximeter
  measure: ARCI Marijuana Scale
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: The ARCI scale measures subjective responses to cannabis. total score ranges from 0-12 where higher is worse
  measure: DRUID Psychomotor Battery
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: The DRUID is a mobile app that tests for cognitive and motor impairment, and has been shown to detect impairment related to alcohol and cannabis use. total score ranges from 0-100 where higher is worse.
  measure: Blood-THC
  time frame: Blood is drawn immediately prior to alcohol and cannabis consumption, again 60 minutes post alcohol administration start time, and again 240 minutes post alcohol start time
  description: We will quantify levels of THC in the blood before and after the participant uses their cannabis product
  measure: Biphasic Effects of Alcohol Scale (BAES)
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: The BAES measures the stimulating and sedating effects of alcohol and is validated for use in laboratory settings. This scale produces a stimulation subscale (total score ranges from 0-70 where higher is more stimulated) and a sedation subscale (total score ranging from 0-70 where higher is more sedated)
  measure: Profile of Mood States (POMS)
  time frame: Baseline (pre ingestion) and every 30 minutes (post ingestion) for a total of 270 minutes (9 measures)
  description: The POMS is a self-report rating scale that assesses state-level, distinct mood states. The POMS produces multiple subscales (Tension, depression, anger, fatigue, confusion, vigour, as well as a total mood disturbance scale)
  arm group label: Alcohol + Cannabis
  arm group type: Experimental
  description: Participants are randomly assigned to receive the standardized alcohol dose during the experimental session prior to going inside their residence to self-administer their preferred cannabis concentrate product or randomly assigned to going inside their residence to self-administer their preferred cannabis concentrate product and then receive the standardized alcohol dose.
  All participants receive alcohol and cannabis, however, the order of ingestion is randomly assigned.
  intervention type: Other
  intervention name: commercially available cannabis and commercially available alcohol
  description: Self administration of cannabis and researcher administered alcohol
  arm group label: Alcohol + Cannabis
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hollis C Karoly, PhD
  role: Principal Investigator
  affiliation: Colorado State University
  last name: Hollis C Karoly, PhD
  phone: 970-491-3677
  email: hollis.karoly@colostate.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Marijuana Abuse
  mesh term: Alcoholism
  sharing ipd: No