<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/NCT01718964</url>
  </required_header>
  <id_info>
    <org_study_id>2012DR2144</org_study_id>
    <nct_id>NCT01718964</nct_id>
  </id_info>
  <brief_title>Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)</brief_title>
  <acronym>Ghost-Basel</acronym>
  <official_title>Acute Effects of Cortisol on Heroin Craving in Opioid Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dominique de Quervain, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Basel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effects of cortisol on heroin craving and stress reaction in heroin&#xD;
      addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single&#xD;
      administration of study medication Study hypothesis:Cortisol has an inhibiting effect on&#xD;
      heroin craving and stress reactivity in opioid dependent subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heroin craving</measure>
    <time_frame>baseline, change from baseline during and after presentation of drug stimuli</time_frame>
    <description>outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>baseline, change from baseline during and after presentation of drug stimuli</time_frame>
    <description>outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Symptoms of withdrawal</measure>
    <time_frame>baseline, change from baseline during and after presentation of drug stimuli</time_frame>
    <description>outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.</description>
  </other_outcome>
  <other_outcome>
    <measure>saliva cortisol level</measure>
    <time_frame>baseline, change from baseline during and after presentation of drug stimuli</time_frame>
    <description>outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cortisol 20 mg /Placebo Mannitol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Placebo Mannitol/Cortisol 20mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cortisol 20 mg</intervention_name>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mannitol</intervention_name>
    <description>Mannitol used as placebo</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Opioid dependency&#xD;
&#xD;
          -  Participant in the Janus heroin programme of the UPK Basel&#xD;
&#xD;
          -  Able to control parallel consumption of other drugs&#xD;
&#xD;
          -  Stable i.v. substitution for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co-morbid psychiatric disturbances&#xD;
&#xD;
          -  Current medical conditions excluding participation&#xD;
&#xD;
          -  Recent history of systemic or topic glucocorticoid therapy&#xD;
&#xD;
          -  known hypersensitivity to the IMP under investigation (cor-tisol)&#xD;
&#xD;
          -  pregnancy, breast-feeding&#xD;
&#xD;
          -  inability to read and understand the participant's information&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Psychiatric Hospital</name>
      <address>
        <city>Basel</city>
        <zip>4012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 29, 2013</last_update_submitted>
  <last_update_submitted_qc>October 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Basel</investigator_affiliation>
    <investigator_full_name>Prof. Dominique de Quervain, MD</investigator_full_name>
    <investigator_title>Professor MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Mannitol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01718964
org study id: 2012DR2144
nct id: NCT01718964
lead sponsor: 
has dmc: Yes
To investigate the effects of cortisol on heroin craving and stress reaction in heroin
      addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single
      administration of study medication Study hypothesis:Cortisol has an inhibiting effect on
      heroin craving and stress reactivity in opioid dependent subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Heroin craving
time frame: baseline, change from baseline during and after presentation of drug stimuli
description: outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
measure: Anxiety
time frame: baseline, change from baseline during and after presentation of drug stimuli
description: outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
measure: Symptoms of withdrawal
time frame: baseline, change from baseline during and after presentation of drug stimuli
description: outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
measure: saliva cortisol level
time frame: baseline, change from baseline during and after presentation of drug stimuli
description: outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
arm group label: A
arm group type: Other
description: Cortisol 20 mg /Placebo Mannitol
arm group label: B
arm group type: Other
description: Placebo Mannitol/Cortisol 20mg
intervention type: Drug
intervention name: Cortisol 20 mg
arm group label: A
arm group label: B
intervention type: Drug
intervention name: Mannitol
description: Mannitol used as placebo
arm group label: A
arm group label: B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Basel
investigator full name: Prof. Dominique de Quervain, MD
investigator title: Professor MD
mesh term: Opioid-Related Disorders
mesh term: Hydrocortisone
mesh term: Mannitol