<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/NCT04419831</url>
  </required_header>
  <id_info>
    <org_study_id>2000026626</org_study_id>
    <nct_id>NCT04419831</nct_id>
  </id_info>
  <brief_title>Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive Learning and Executive Function</brief_title>
  <official_title>Characterizing Subjective and Physiological Responses to Stress and Pain and Cognitive</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study design is to assess the between groups factor (controls, chronic pain, addicted&#xD;
      individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a&#xD;
      longitudinal component to assess stress, pain and addictive behaviors in daily life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This proposal aims to systematically examine the physiologic, neuroendocrine and behavioral&#xD;
      stress and pain responses to an adapted Cold Pressor Test and also assess specific cognitive&#xD;
      and executive function tests in community volunteers with a history of stress and trauma,&#xD;
      social users of alcohol, cannabis and individuals with alcohol use disorder, cannabis use&#xD;
      disorder, opioid use disorder, cocaine use disorder and chronic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 14, 2022</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessments</measure>
    <time_frame>3 years</time_frame>
    <description>Pain will be assessed by asking participants, &quot;Right now, how much pain do you feel?&quot; asked using the VAS scale ranging from 0 to 100 as outlined in the Laboratory Pain Ratings assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug craving</measure>
    <time_frame>3 years</time_frame>
    <description>Drug craving will be assessed by asking participants, &quot;Right now, how much do you want to use your preferred drug?&quot; This item will be presented in all assessments throughout the study period. Participants will be asked, &quot;How much drug did you use in drinks/grams,&quot; that day in the evening prompt and in the previous day in the evening prompt.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood and anxiety assessments</measure>
    <time_frame>3 years</time_frame>
    <description>The Positive and Negative Affect Schedule (PANAS) measures positive and negative mood and anxiety measures during the initial 28-day period. Participants respond to a 20-item test using a 5-point scale ranging from very slightly or not at all (1) to extremely (5) on the EMA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Food consumption</measure>
    <time_frame>3 years</time_frame>
    <description>Food consumption will be assessed via the evening survey during the initial 28-day period. Participants will respond with the top three types of food that they ate (e.g., &quot;vegetables/salad&quot;, &quot;sweet food/dessert&quot;, &quot;white meat (e.g., fish/chicken)&quot;) and to what extent did they continue eating after feeling full (1=Not at all, 100=Very much).</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pain Response, Stress, Trauma</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Binge Heavy drinkers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cannabis Use Disorder</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Alcohol Use Disorder</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Individuals with Moderate to Severe Pain</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Opioid Use Disorder in medication assisted treatment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cold Pressor Task</intervention_name>
    <description>Cold Pressor Task</description>
    <arm_group_label>Alcohol Use Disorder</arm_group_label>
    <arm_group_label>Binge Heavy drinkers</arm_group_label>
    <arm_group_label>Cannabis Use Disorder</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Individuals with Moderate to Severe Pain</arm_group_label>
    <arm_group_label>Opioid Use Disorder in medication assisted treatment</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stress hormones Cortisol and ACTH&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers and those with chronic pain, those with alcohol use disorder, and those&#xD;
        with cannabis use disorder.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between ages 18-50 years;&#xD;
&#xD;
          2. Able to read and write English;&#xD;
&#xD;
          3. 50 individuals meeting DSM V criteria for Binge Heavy drinkers, using NIAAA criteria&#xD;
             for alcohol intake 50 individuals meeting DSM V criteria for Cannabis Use Disorder 50&#xD;
             individuals meeting DSM V criteria for Alcohol Use Disorder 50 Individuals with&#xD;
             Moderate to Severe Pain 50 individuals meeting DSM V criteria for Opioid Use Disorder&#xD;
             who are initiating treatment&#xD;
&#xD;
          4. Physically healthy as determined by Physical Exam, EKG and blood analyses&#xD;
&#xD;
          5. Body Mass Index (BMI) in the 18-30 range;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any psychotic disorder or current psychiatric symptoms requiring specific attention,&#xD;
             including active symptoms of psychosis or suicidal/homicidal ideation.&#xD;
&#xD;
          2. Any Current Substance Use Disorder including alcohol, cannabis, cocaine, opioids,&#xD;
             sedatives/hypnotics. For alcohol, cannabis, and opioid subjects, exclusion for the&#xD;
             abused drug will not apply.&#xD;
&#xD;
          3. Individuals taking any prescription medications or over-the counter medications&#xD;
             regularly;&#xD;
&#xD;
          4. Women with irregular menstrual cycles or who are nursing, dysmennorheic, amenorrheic,&#xD;
             menopausal, or had premenstrual dysphoric disorder or those on birth control pills;&#xD;
&#xD;
          5. Women who are pregnant as determined by the urine pregnancy test at each laboratory&#xD;
             admission;&#xD;
&#xD;
          6. Inability to give informed consent;&#xD;
&#xD;
          7. Traumatic brain injury or loss of consciousness;&#xD;
&#xD;
          8. Individuals with current or past history of seizure disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>RAJITA SINHA</last_name>
    <phone>1203737-5805</phone>
    <email>rajita.sinha@yale.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel Hart, MA</last_name>
    <phone>1203-737-4791</phone>
    <email>rachel.hart@yale.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Yale Stress Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Hart, MA</last_name>
      <phone>203-737-4791</phone>
      <email>rachel.hart@yale.edu</email>
    </contact>
    <contact_backup>
      <last_name>Cindy Tappe, MBA</last_name>
      <email>cindy.tappe@yale.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rajita Sinha, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04419831
org study id: 2000026626
nct id: NCT04419831
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study design is to assess the between groups factor (controls, chronic pain, addicted
      individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a
      longitudinal component to assess stress, pain and addictive behaviors in daily life.
This proposal aims to systematically examine the physiologic, neuroendocrine and behavioral
      stress and pain responses to an adapted Cold Pressor Test and also assess specific cognitive
      and executive function tests in community volunteers with a history of stress and trauma,
      social users of alcohol, cannabis and individuals with alcohol use disorder, cannabis use
      disorder, opioid use disorder, cocaine use disorder and chronic pain.
observational model: Case-Control
time perspective: Prospective
measure: Pain assessments
time frame: 3 years
description: Pain will be assessed by asking participants, "Right now, how much pain do you feel?" asked using the VAS scale ranging from 0 to 100 as outlined in the Laboratory Pain Ratings assessment
measure: Drug craving
time frame: 3 years
description: Drug craving will be assessed by asking participants, "Right now, how much do you want to use your preferred drug?" This item will be presented in all assessments throughout the study period. Participants will be asked, "How much drug did you use in drinks/grams," that day in the evening prompt and in the previous day in the evening prompt.
measure: Mood and anxiety assessments
time frame: 3 years
description: The Positive and Negative Affect Schedule (PANAS) measures positive and negative mood and anxiety measures during the initial 28-day period. Participants respond to a 20-item test using a 5-point scale ranging from very slightly or not at all (1) to extremely (5) on the EMA.
measure: Food consumption
time frame: 3 years
description: Food consumption will be assessed via the evening survey during the initial 28-day period. Participants will respond with the top three types of food that they ate (e.g., "vegetables/salad", "sweet food/dessert", "white meat (e.g., fish/chicken)") and to what extent did they continue eating after feeling full (1=Not at all, 100=Very much).
arm group label: Healthy volunteers
arm group label: Binge Heavy drinkers
arm group label: Cannabis Use Disorder
arm group label: Alcohol Use Disorder
arm group label: Individuals with Moderate to Severe Pain
arm group label: Opioid Use Disorder in medication assisted treatment
intervention type: Diagnostic Test
intervention name: Cold Pressor Task
description: Cold Pressor Task
arm group label: Alcohol Use Disorder
arm group label: Binge Heavy drinkers
arm group label: Cannabis Use Disorder
arm group label: Healthy volunteers
arm group label: Individuals with Moderate to Severe Pain
arm group label: Opioid Use Disorder in medication assisted treatment
Stress hormones Cortisol and ACTH
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: RAJITA SINHA
phone: 1203737-5805
email: rajita.sinha@yale.edu
last name: Rachel Hart, MA
phone: 1203-737-4791
email: rachel.hart@yale.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No