<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/NCT01672723</url>
  </required_header>
  <id_info>
    <org_study_id>Opioids and Social Cognition</org_study_id>
    <nct_id>NCT01672723</nct_id>
  </id_info>
  <brief_title>Neuropharmacological Basis of Social Connection: The Role of Opioids</brief_title>
  <official_title>Neuropharmacological Basis of Social Connection: The Role of Opioids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      From birth we rely on others for comfort and care and derive pleasure from being together.&#xD;
      Research from the fields of health psychology, social psychology, and public health converge&#xD;
      to highlight the importance of having and maintaining good relationships for overall health.&#xD;
      Indeed, having close friends and family and feeling connected to them has been called a basic&#xD;
      need, similar to our need for food and water. It may not be a coincidence then that feelings&#xD;
      of connection rely on similar systems in the body as other needs that are both basic and&#xD;
      highly pleasing and rewarding. For instance, its possible that opioids, a substance in the&#xD;
      body associated with pleasant, euphoric feelings, may also be important for connecting with&#xD;
      others. This study will examine the role of opioids in feeling connected to others by&#xD;
      administering a drug called naltrexone, that effects opioid processing in the body, on&#xD;
      perceptions and feelings toward a number of tasks in the lab. Additionally, to assess the&#xD;
      effects of naltrexone outside of the lab, participants will complete daily diary responses&#xD;
      via text and online surveys.&#xD;
&#xD;
      40 participants will take both placebo and naltrexone. Participants will complete two&#xD;
      sessions, one in each drug condition, in which they complete a number of tasks including&#xD;
      reading messages on a computer screen, holding a number of objects, and viewing images while&#xD;
      undergoing electric shocks. Participants will also complete a daily diary for 14 days while&#xD;
      on naltrexone and placebo. Prior to these lab sessions participants will be screened at&#xD;
      UCLA's Clinical &amp; Translational Research Center (CTRC) to ensure that they are healthy and&#xD;
      that it is safe for them to take the study drug.&#xD;
&#xD;
      We hypothesize that people will report feeling less socially connected when on naltrexone&#xD;
      compared to placebo and will show subsequent changes in social behavior outside of the lab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)</measure>
    <time_frame>participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment</time_frame>
    <description>Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by &quot;not at all&quot; and &quot;very.&quot; Higher numbers indicate greater feelings of connection in response to reading the loving messages.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily Self-reported Feelings of Social Connection</measure>
    <time_frame>end of day for 8 days</time_frame>
    <description>For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (&quot;I felt out of touch and disconnected from others&quot;). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-reported Physical Symptoms</measure>
    <time_frame>once a day for 8 days</time_frame>
    <description>At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.&#xD;
Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Psychology, Social</condition>
  <arm_group>
    <arm_group_label>Naltrexone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebi</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naltrexone</intervention_name>
    <arm_group_label>Naltrexone</arm_group_label>
    <arm_group_label>Placebi</arm_group_label>
    <other_name>Depade</other_name>
    <other_name>ReVia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for the study require that participants be in good health, between the&#xD;
        ages of 18 and 35, fluent in English, have access to text messaging technology, and have at&#xD;
        least 8 close friends and family members who would be willing to be contacted in regards to&#xD;
        the study (for the social connection lab task) and be willing to provide 2 pictures of a&#xD;
        close other (for the threat of shock task).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Following an email screening and structured telephone interview, prospective participants&#xD;
        with the following conditions will not advance to the in- person screening session:&#xD;
        pregnant or planning to become pregnant in the next 6 months, presence of chronic mental or&#xD;
        physical illness, history of allergies, liver, or other severe chronic diseases, current&#xD;
        and regular use of prescription medications, or previous history of fainting during blood&#xD;
        draws.&#xD;
&#xD;
        Furthermore, the absence of significant health problems or medication use history will be&#xD;
        confirmed by an in-person screening session. Any participant who has any of the following&#xD;
        conditions will be ineligible for the study: (1) Any and all medical conditions, especially&#xD;
        hepatitis or liver failure.&#xD;
&#xD;
        Psychiatric Disorders. (2) current and/or lifetime history of a major Depressive Disorder&#xD;
        or other Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) psychiatric&#xD;
        disorder (e.g. substance dependence) (3) current and/or past regular use of analgesics such&#xD;
        as opioids; (4) current and/or past regular use of psychotropic medications, including&#xD;
        selective serotonergic reuptake inhibitors, antidepressants, anxiolytics, hypnotics,&#xD;
        sedatives and barbiturates. Health factors. (5) current smokers (13) body mass index (BMI)&#xD;
        greater than 35, (14) shows evidence of drug use from a urine test, (15) has a positive&#xD;
        pregnancy test, if female, or (16) shows any abnormalities on screening laboratory tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi I Eisenberger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles Department of Psychology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>May 29, 2015</results_first_submitted>
  <results_first_submitted_qc>December 10, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 14, 2016</results_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Naomi Eisenberger</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>opioids</keyword>
  <keyword>social connection</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naltrexone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from the UCLA community and surrounding areas and were run between December 2012 and February 2014.</recruitment_details>
      <pre_assignment_details>50 screened, 19 excluded (1 asked to be removed, 15 did not respond to additional scheduling requests or additional requests for information for the lab task, 3 reported stomach discomfort at a severe level and were removed).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Naltrexone First, Then Placebo</title>
          <description>Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo First, Then Naltrexone</title>
          <description>Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period of 10 Days</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Naltrexone First and Placebo First</title>
          <description>Includes groups randomized to receive naltrexone first and placebo first.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.55" spread="3.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)</title>
        <description>Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by &quot;not at all&quot; and &quot;very.&quot; Higher numbers indicate greater feelings of connection in response to reading the loving messages.</description>
        <time_frame>participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.&#xD;
Naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)</title>
          <description>Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by &quot;not at all&quot; and &quot;very.&quot; Higher numbers indicate greater feelings of connection in response to reading the loving messages.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.92" spread=".189"/>
                    <measurement group_id="O2" value="6.47" spread=".183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Self-reported Feelings of Social Connection</title>
        <description>For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (&quot;I felt out of touch and disconnected from others&quot;). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).</description>
        <time_frame>end of day for 8 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.&#xD;
Naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Self-reported Feelings of Social Connection</title>
          <description>For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (&quot;I felt out of touch and disconnected from others&quot;). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.68" spread="0.29"/>
                    <measurement group_id="O2" value="6.26" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Self-reported Physical Symptoms</title>
        <description>At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.&#xD;
Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo.</description>
        <time_frame>once a day for 8 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Naltrexone</title>
            <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.&#xD;
Naltrexone</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Physical Symptoms</title>
          <description>At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.&#xD;
Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".391" spread=".039"/>
                    <measurement group_id="O2" value=".101" spread=".070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>naltrexone administered once daily for 4 days (25mg for days 1 and 2, 50mg for days 3 and 4) placebo administered once daily for 4 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Naltrexone</title>
          <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.&#xD;
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>stomach discomfort</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Naomi Eisenberger</name_or_title>
      <organization>University of California, Los Angeles</organization>
      <phone>310-267-5196</phone>
      <email>neisenbe@ucla.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01672723
org study id: Opioids and Social Cognition
nct id: NCT01672723
lead sponsor: 
has dmc: No
From birth we rely on others for comfort and care and derive pleasure from being together.
      Research from the fields of health psychology, social psychology, and public health converge
      to highlight the importance of having and maintaining good relationships for overall health.
      Indeed, having close friends and family and feeling connected to them has been called a basic
      need, similar to our need for food and water. It may not be a coincidence then that feelings
      of connection rely on similar systems in the body as other needs that are both basic and
      highly pleasing and rewarding. For instance, its possible that opioids, a substance in the
      body associated with pleasant, euphoric feelings, may also be important for connecting with
      others. This study will examine the role of opioids in feeling connected to others by
      administering a drug called naltrexone, that effects opioid processing in the body, on
      perceptions and feelings toward a number of tasks in the lab. Additionally, to assess the
      effects of naltrexone outside of the lab, participants will complete daily diary responses
      via text and online surveys.

      40 participants will take both placebo and naltrexone. Participants will complete two
      sessions, one in each drug condition, in which they complete a number of tasks including
      reading messages on a computer screen, holding a number of objects, and viewing images while
      undergoing electric shocks. Participants will also complete a daily diary for 14 days while
      on naltrexone and placebo. Prior to these lab sessions participants will be screened at
      UCLA's Clinical & Translational Research Center (CTRC) to ensure that they are healthy and
      that it is safe for them to take the study drug.

      We hypothesize that people will report feeling less socially connected when on naltrexone
      compared to placebo and will show subsequent changes in social behavior outside of the lab.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)
time frame: participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment
description: Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by "not at all" and "very." Higher numbers indicate greater feelings of connection in response to reading the loving messages.
measure: Daily Self-reported Feelings of Social Connection
time frame: end of day for 8 days
description: For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt ("I felt out of touch and disconnected from others"). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone).
measure: Self-reported Physical Symptoms
time frame: once a day for 8 days
description: At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.
Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo.
arm group label: Naltrexone
arm group type: Experimental
description: Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.
arm group label: Placebi
arm group type: Placebo Comparator
description: Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.
Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.
intervention type: Drug
intervention name: Naltrexone
arm group label: Naltrexone
arm group label: Placebi
other name: Depade
other name: ReVia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi I Eisenberger, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Naomi Eisenberger
investigator title: Associate Professor
mesh term: Naltrexone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 