<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/NCT03837860</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20180167</org_study_id>
    <nct_id>NCT03837860</nct_id>
  </id_info>
  <brief_title>Reducing the Abuse of Opioids in Drug Users</brief_title>
  <official_title>Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The consequences of prescription opioid abuse are serious and the number of deaths from&#xD;
      unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among&#xD;
      the most commonly abused class of substances in the United States. Moreover, patients who&#xD;
      take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with&#xD;
      as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing&#xD;
      access to prescription opioid analgesics due to an increasingly negative prescribing climate&#xD;
      and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain&#xD;
      patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating&#xD;
      and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a&#xD;
      proverbial &quot;catch-22&quot; situation whereby treating a patient's chronic pain also exposes them&#xD;
      to medications with substantial abuse liability and overdose risk. In this proposal, a method&#xD;
      aimed at reducing the abuse potential of prescription opioid medications, without altering&#xD;
      their analgesic efficacy, is described.&#xD;
&#xD;
      The study team hypothesize that this can be accomplished by administering a&#xD;
      fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or&#xD;
      capsule.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI leaving institution&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">January 21, 2022</completion_date>
  <primary_completion_date type="Actual">March 23, 2021</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Double-blinded, crossover study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bipolar Visual Analog Scale (VAS) of Drug Likability</measure>
    <time_frame>Study visit 2 to study visit 6, an average of 10 days</time_frame>
    <description>The bipolar VAS is used to measure the Change in magnitude of &quot;drug liking&quot;. The Drug Effects Questionnaire AKA the bipolar VAS of Drug Likability is a 5 item self-administered assessment where participants place a mark on a line from 0 to 100, &quot;strongly dislike&quot; at 0 (on the left hand side), &quot;no effect&quot; at 50 (in the center) and &quot;strongly like&quot; at 100 (on the far right). Change from visit 2 to visit 6 will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Profile of Mood States (POMS)</measure>
    <time_frame>Study visit 2 to study visit 6, an average of 10 days</time_frame>
    <description>POMS is a self-administered, standard validated psychological test formulated by McNair et al. (1971). It is a used to assess transient, distinct mood states. The questionnaire contains 65 words/statements that describe feelings people have. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Addiction Research Center Inventory Short Form (ARCI-SF)</measure>
    <time_frame>Study visit 2 to study visit 6, an average of 10 days</time_frame>
    <description>The ARCI is a self-administered, standardized questionnaire for assessing subjective effects of psychoactive drugs that was developed in the early 1960s at the National Institute of Mental Health Addiction Research Center. For this study, we will be using the 49-item short form. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Opioid Abuse, Unspecified</condition>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Oxycodone/Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone/Risperidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone/Ziprasidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone/Placebo</intervention_name>
    <description>Oxycodone 20 mg plus placebo</description>
    <arm_group_label>Oxycodone/Placebo</arm_group_label>
    <other_name>Oxycontin/Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone/Risperidone</intervention_name>
    <description>Oxycodone (20mg) plus Risperidone (2 mg)</description>
    <arm_group_label>Oxycodone/Risperidone</arm_group_label>
    <other_name>Oxycontin/Risperdal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone/Ziprasidone</intervention_name>
    <description>Oxycodone (20mg) plus Ziprasidone (80 mg)</description>
    <arm_group_label>Oxycodone/Ziprasidone</arm_group_label>
    <other_name>Oxycontin/Geodon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients between 21 to 65 years of age, capable of understanding and providing&#xD;
             consent in English, and capable of complying with the outcome instruments used.&#xD;
&#xD;
          -  Recreational opioid use (i.e. defined as prescription opioid use for nontherapeutic&#xD;
             purposes on at least 10 occasions within the previous year and at least once in the 12&#xD;
             weeks prior to screening)&#xD;
&#xD;
          -  Reported tolerated doses to opioid medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or&#xD;
             past history of major psychiatric disorder such as bipolar disorder/psychosis&#xD;
&#xD;
          -  Presence of dementia&#xD;
&#xD;
          -  Current neuroleptic medication in past 30 days&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Positive drug urine test for Barbiturates, Benzodiazepines, Methadone, and&#xD;
             Buprenorphine.&#xD;
&#xD;
          -  Subjects with a prolonged QT interval greater than 430ms (i.e. QTc &gt;430ms)&#xD;
&#xD;
          -  Subjects with a heart rate of less than 60 or greater than 100bpm will be assessed by&#xD;
             a physician for symptomatic bradycardia/tachycardia and eligibility determined on a&#xD;
             case-by-case basis&#xD;
&#xD;
          -  Subjects with serum potassium and/or magnesium outside of normal range of our&#xD;
             institutional laboratory within the past three months from time of screening.&#xD;
&#xD;
          -  Subjects who appears intoxicated on the day of study visit by an on-site physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ameet Nagpal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Health San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Westgate Pain Clinic</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Oxycodone</mesh_term>
    <mesh_term>Risperidone</mesh_term>
    <mesh_term>Ziprasidone</mesh_term>
  </intervention_browse>
  <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/NCT03837860
org study id: HSC20180167
nct id: NCT03837860
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The consequences of prescription opioid abuse are serious and the number of deaths from
      unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among
      the most commonly abused class of substances in the United States. Moreover, patients who
      take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with
      as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing
      access to prescription opioid analgesics due to an increasingly negative prescribing climate
      and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain
      patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating
      and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a
      proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them
      to medications with substantial abuse liability and overdose risk. In this proposal, a method
      aimed at reducing the abuse potential of prescription opioid medications, without altering
      their analgesic efficacy, is described.

      The study team hypothesize that this can be accomplished by administering a
      fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or
      capsule.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Double-blinded, crossover study
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Bipolar Visual Analog Scale (VAS) of Drug Likability
time frame: Study visit 2 to study visit 6, an average of 10 days
description: The bipolar VAS is used to measure the Change in magnitude of "drug liking". The Drug Effects Questionnaire AKA the bipolar VAS of Drug Likability is a 5 item self-administered assessment where participants place a mark on a line from 0 to 100, "strongly dislike" at 0 (on the left hand side), "no effect" at 50 (in the center) and "strongly like" at 100 (on the far right). Change from visit 2 to visit 6 will be measured.
measure: Change in Profile of Mood States (POMS)
time frame: Study visit 2 to study visit 6, an average of 10 days
description: POMS is a self-administered, standard validated psychological test formulated by McNair et al. (1971). It is a used to assess transient, distinct mood states. The questionnaire contains 65 words/statements that describe feelings people have. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.
measure: Change in Addiction Research Center Inventory Short Form (ARCI-SF)
time frame: Study visit 2 to study visit 6, an average of 10 days
description: The ARCI is a self-administered, standardized questionnaire for assessing subjective effects of psychoactive drugs that was developed in the early 1960s at the National Institute of Mental Health Addiction Research Center. For this study, we will be using the 49-item short form. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.
arm group label: Oxycodone/Placebo
arm group type: Active Comparator
description: Each study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo
arm group label: Oxycodone/Risperidone
arm group type: Active Comparator
description: Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone
arm group label: Oxycodone/Ziprasidone
arm group type: Active Comparator
description: Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone
intervention type: Drug
intervention name: Oxycodone/Placebo
description: Oxycodone 20 mg plus placebo
arm group label: Oxycodone/Placebo
other name: Oxycontin/Placebo
intervention type: Drug
intervention name: Oxycodone/Risperidone
description: Oxycodone (20mg) plus Risperidone (2 mg)
arm group label: Oxycodone/Risperidone
other name: Oxycontin/Risperdal
intervention type: Drug
intervention name: Oxycodone/Ziprasidone
description: Oxycodone (20mg) plus Ziprasidone (80 mg)
arm group label: Oxycodone/Ziprasidone
other name: Oxycontin/Geodon
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ameet Nagpal, MD
role: Principal Investigator
affiliation: UT Health San Antonio
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Oxycodone
mesh term: Risperidone
mesh term: Ziprasidone
sharing ipd: No