<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/NCT02239913</url>
  </required_header>
  <id_info>
    <org_study_id>BED IN 27</org_study_id>
    <secondary_id>R01DA032254</secondary_id>
    <nct_id>NCT02239913</nct_id>
  </id_info>
  <brief_title>Topiramate-Phentermine Combinations for Cocaine Dependence</brief_title>
  <official_title>Topiramate-Phentermine Combinations for Cocaine Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kentucky</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),&#xD;
      alone and in combination, on the reinforcing, subjective and physiological effects of&#xD;
      cocaine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reinforcing Effects</measure>
    <time_frame>Nine times over approximately five weeks inpatient admission.</time_frame>
    <description>The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective effects</measure>
    <time_frame>Nine times over approximately five weeks inpatient admission.</time_frame>
    <description>Subjects will complete subjective effects measures during nine sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological Effects</measure>
    <time_frame>Daily over approximately five week inpatient admissions</time_frame>
    <description>Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>Daily over approximately five weeks of inpatient admission</time_frame>
    <description>Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Cocaine Use Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and phentermine during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topiramate Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topiramate Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cocaine</intervention_name>
    <description>The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Topiramate Dose 1</arm_group_label>
    <arm_group_label>Topiramate Dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Topiramate Dose 1</arm_group_label>
    <arm_group_label>Topiramate Dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phentermine</intervention_name>
    <description>The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Topiramate Dose 1</arm_group_label>
    <arm_group_label>Topiramate Dose 2</arm_group_label>
    <other_name>Adipex®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topiramate</intervention_name>
    <description>The pharmacodynamic effects of chronic topiramate will be determined.</description>
    <arm_group_label>Topiramate Dose 1</arm_group_label>
    <arm_group_label>Topiramate Dose 2</arm_group_label>
    <other_name>Topamax®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recent cocaine use by the intranasal or intravenous route&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians&#xD;
             deem clinically significant&#xD;
&#xD;
          -  Current or past histories of substance abuse or dependence that are deemed by the&#xD;
             study physicians to interfere with study completion&#xD;
&#xD;
          -  History of serious physical disease, current physical disease, impaired cardiovascular&#xD;
             functioning, chronic obstructive pulmonary disease, history of seizure or current or&#xD;
             past histories of serious psychiatric disorder that in the opinion of the study&#xD;
             physician would interfere with study participation will be excluded from participation&#xD;
&#xD;
          -  Females not currently using effective birth control&#xD;
&#xD;
          -  Contraindications to cocaine, topiramate or phentermine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig R Rush, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kentucky</investigator_affiliation>
    <investigator_full_name>Craig Rush</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cocaine</keyword>
  <keyword>Pharmacotherapy</keyword>
  <keyword>Phentermine</keyword>
  <keyword>Topiramate</keyword>
  <keyword>Self-Administration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cocaine-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Topiramate</mesh_term>
    <mesh_term>Phentermine</mesh_term>
    <mesh_term>Cocaine</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/NCT02239913
org study id: BED IN 27
secondary id: R01DA032254
nct id: NCT02239913
lead sponsor: 
collaborator: 
has dmc: Yes
This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),
      alone and in combination, on the reinforcing, subjective and physiological effects of
      cocaine.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Reinforcing Effects
time frame: Nine times over approximately five weeks inpatient admission.
description: The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses.
measure: Subjective effects
time frame: Nine times over approximately five weeks inpatient admission.
description: Subjects will complete subjective effects measures during nine sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.
measure: Physiological Effects
time frame: Daily over approximately five week inpatient admissions
description: Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure.
measure: Side effects
time frame: Daily over approximately five weeks of inpatient admission
description: Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and phentermine during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
arm group label: Topiramate Dose 1
arm group type: Experimental
description: Subjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
arm group label: Topiramate Dose 2
arm group type: Experimental
description: Subjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
intervention type: Drug
intervention name: Cocaine
description: The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
arm group label: Placebo
arm group label: Topiramate Dose 1
arm group label: Topiramate Dose 2
intervention type: Drug
intervention name: Placebo
description: The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
arm group label: Placebo
arm group label: Topiramate Dose 1
arm group label: Topiramate Dose 2
intervention type: Drug
intervention name: Phentermine
description: The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
arm group label: Placebo
arm group label: Topiramate Dose 1
arm group label: Topiramate Dose 2
other name: Adipex®
intervention type: Drug
intervention name: Topiramate
description: The pharmacodynamic effects of chronic topiramate will be determined.
arm group label: Topiramate Dose 1
arm group label: Topiramate Dose 2
other name: Topamax®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Craig R Rush, Ph.D.
role: Principal Investigator
affiliation: University of Kentucky
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kentucky
investigator full name: Craig Rush
investigator title: Professor
mesh term: Cocaine-Related Disorders
mesh term: Topiramate
mesh term: Phentermine
mesh term: Cocaine