xml: <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/NCT05995535</url>
    </required_header>
    <id_info>
      <org_study_id>854046</org_study_id>
      <nct_id>NCT05995535</nct_id>
    </id_info>
    <brief_title>Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal</brief_title>
    <acronym>UH3</acronym>
    <official_title>Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pennsylvania</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>
        A placebo-controlled trial in which male and female outpatients with an opioid use disorder&#xD;
        who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to&#xD;
        lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered&#xD;
        XR-NTX if after completing withdrawal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A placebo-controlled trial in which male and female outpatients with an opioid use disorder&#xD;
        who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to&#xD;
        lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered&#xD;
        XR-NTX if after completing withdrawal. It follows a UG3 study in which 90 inpatients with an&#xD;
        OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with&#xD;
        lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were&#xD;
        equally safe, and that lofexidine/pregabalin was more effective in reducing subjective&#xD;
        withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin.&#xD;
  &#xD;
        The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to&#xD;
        lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient&#xD;
        settings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Active pregabalin plus lofexidine versus placebo pregabalin plus lofexidine</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>double-blind placebo-controlled randomized trial</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Subjective Opioid Withdrawal Scale (SOWS) scores</measure>
      <time_frame>10 days per subject, through study completion (N=150)</time_frame>
      <description>Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Study detox completion</measure>
      <time_frame>10 days per subject, through study completion (N=150)</time_frame>
      <description>Proportion that receives one or more doses of study medication and completed withdrawal (Completing withdrawal management will be defined as having received at least 1 dose of study medication on day 8 and completing the SOWS-Gossop assessment on day 8); and proportion that transition to XR-NTX; adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>XR-NTX IM injection</measure>
      <time_frame>upto 2 days per subject (N=150)</time_frame>
      <description>proportion that receives 380mg dose of extended-release naltrexone</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Opiate Withdrawal Syndrome</condition>
    <condition>Opioid Use</condition>
    <arm_group>
      <arm_group_label>LFX/PGB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PGB/day 1=400mg, day 2-7=600mg each day, day 8=400mg, day 9=200mg, day 10=100mg&#xD;
  LFX/day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LFX/PLA-PGB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PLA-PGB/day 1-7= 0mg each day, day 8, 9, and 10 =0mg each day&#xD;
  LFX/ day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LFX/PGB</intervention_name>
      <description>lofexidine tablets 0.18mg tabs&#xD;
  pregabalin capsules 100mg and 25mg</description>
      <arm_group_label>LFX/PGB</arm_group_label>
      <arm_group_label>LFX/PLA-PGB</arm_group_label>
      <other_name>Lucemyra</other_name>
      <other_name>lyrica</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LFX/PLA-PGB</intervention_name>
      <description>lofexidine tablets 0.18mg tabs&#xD;
  pregabalin capsules 0mg</description>
      <arm_group_label>LFX/PGB</arm_group_label>
      <arm_group_label>LFX/PLA-PGB</arm_group_label>
      <other_name>Lucemyra</other_name>
      <other_name>placebo pregabalin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and/or female subjects ≥ 18 years of age&#xD;
  &#xD;
            2. Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have met 2&#xD;
               or more of the 11 criteria for an OUD including tolerance and withdrawal within the&#xD;
               last 12 months&#xD;
  &#xD;
            3. Interested in opioid antagonist treatment&#xD;
  &#xD;
            4. Used opioids in 20 or more of the last 30 days&#xD;
  &#xD;
            5. A stable address in the local area; not planning to move in the next 60 days.&#xD;
  &#xD;
            6. Have documents for ID check&#xD;
  &#xD;
            7. Absence of medical or psychiatric conditions that are likely to interfere with study&#xD;
               participation&#xD;
  &#xD;
            8. Has 12 lead ECG demonstrating a QTc ≤450 msec and a QRS ≤120 msec. Site PI has final&#xD;
               determination for study inclusion if readings exceed these limits. The PENN&#xD;
               cardiologists and medical monitor are available for consultation when needed&#xD;
  &#xD;
            9. Negative pregnancy test and using adequate contraception if of childbearing potential.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in&#xD;
               remission&#xD;
  &#xD;
            2. Alcohol, benzodiazepine, or other sedative use disorder with physiological features&#xD;
               that require medication for detoxification&#xD;
  &#xD;
            3. Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or&#xD;
               lofexidine&#xD;
  &#xD;
            4. Pending incarceration or plans to leave the immediate area in the next 30 days&#xD;
  &#xD;
            5. Homicidal or otherwise behaviorally disturbed requiring immediate attention&#xD;
  &#xD;
            6. High risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on&#xD;
               C-SSRS&#xD;
  &#xD;
            7. Blood pressure &lt;90 mm Hg (systolic) or &lt;60 mm Hg (diastolic). If value out of normal&#xD;
               range, the investigator and study Clinician will decide subject inclusion/exclusion on&#xD;
               case-by-case basis&#xD;
  &#xD;
            8. Heart rate and/or pulse&lt;50 bpm at screening-sitting&#xD;
  &#xD;
            9. An Estimated Glomerular Filtration Rate eGFR&lt;70 mL/min/1.73m2&#xD;
  &#xD;
           10. A History of, or current Seizure disorder (excluding childhood febrile seizures)&#xD;
  &#xD;
           11. Inability to read and/or understand English. For example, unable to understand the&#xD;
               informed consent as demonstrated by failing to answer 9/10 questions correctly on the&#xD;
               quiz&#xD;
  &#xD;
           12. 12. Pregnant or breastfeeding&#xD;
  &#xD;
           13. 13. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic&#xD;
  &#xD;
           14. ALT and/or AST &gt;4X upper limit of normal&#xD;
  &#xD;
           15. A Child-Pugh score &gt;7&#xD;
  &#xD;
           16. Currently receiving opioids for pain management&#xD;
  &#xD;
           17. In a treatment study where medication was administered in the last 30 days&#xD;
  &#xD;
           18. Currently using medications that are known to be strong or moderate inhibitors of&#xD;
               CYP2D6 such as fluoxetine, paroxetine, mirabegron, bupropion, quinidine, terbinafine,&#xD;
               cimetidine, cinacalcet, duloxetine, or fluvoxamine&#xD;
  &#xD;
           19. In a methadone maintenance or buprenorphine treatment program within the last 30 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kyle M Kampman, MD</last_name>
      <phone>215-746-2764</phone>
      <email>Kampman@pennmedicine.upenn.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Matthew R Taylor</last_name>
      <phone>215-746-0467</phone>
      <email>matthew.taylor@pennmedicine.upenn.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Pennsylvania, Treatment Research Center</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
      <investigator_full_name>Kyle Kampman</investigator_full_name>
      <investigator_title>Professor, Psychiatry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance Withdrawal Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lofexidine</mesh_term>
      <mesh_term>Clonidine</mesh_term>
      <mesh_term>Pregabalin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995535
  org study id: 854046
  nct id: NCT05995535
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  A placebo-controlled trial in which male and female outpatients with an opioid use disorder
        who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to
        lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered
        XR-NTX if after completing withdrawal.
  A placebo-controlled trial in which male and female outpatients with an opioid use disorder
        who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to
        lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered
        XR-NTX if after completing withdrawal. It follows a UG3 study in which 90 inpatients with an
        OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with
        lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were
        equally safe, and that lofexidine/pregabalin was more effective in reducing subjective
        withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin.
  
        The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to
        lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient
        settings.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Active pregabalin plus lofexidine versus placebo pregabalin plus lofexidine
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: double-blind placebo-controlled randomized trial
  measure: Subjective Opioid Withdrawal Scale (SOWS) scores
  time frame: 10 days per subject, through study completion (N=150)
  description: Subjective patient reported Opioid Withdrawal measured by the SOWS, (0-30); 0 = no withdrawal/30 = severe withdrawal
  measure: Study detox completion
  time frame: 10 days per subject, through study completion (N=150)
  description: Proportion that receives one or more doses of study medication and completed withdrawal (Completing withdrawal management will be defined as having received at least 1 dose of study medication on day 8 and completing the SOWS-Gossop assessment on day 8); and proportion that transition to XR-NTX; adverse events
  measure: XR-NTX IM injection
  time frame: upto 2 days per subject (N=150)
  description: proportion that receives 380mg dose of extended-release naltrexone
  arm group label: LFX/PGB
  arm group type: Experimental
  description: PGB/day 1=400mg, day 2-7=600mg each day, day 8=400mg, day 9=200mg, day 10=100mg
  LFX/day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg
  arm group label: LFX/PLA-PGB
  arm group type: Active Comparator
  description: PLA-PGB/day 1-7= 0mg each day, day 8, 9, and 10 =0mg each day
  LFX/ day 1=1.62mg, day 2-7=2.16mg each day, day 8=1.44mg, day 9=0.72mg, day 10=0.72mg
  intervention type: Drug
  intervention name: LFX/PGB
  description: lofexidine tablets 0.18mg tabs
  pregabalin capsules 100mg and 25mg
  arm group label: LFX/PGB
  arm group label: LFX/PLA-PGB
  other name: Lucemyra
  other name: lyrica
  intervention type: Drug
  intervention name: LFX/PLA-PGB
  description: lofexidine tablets 0.18mg tabs
  pregabalin capsules 0mg
  arm group label: LFX/PGB
  arm group label: LFX/PLA-PGB
  other name: Lucemyra
  other name: placebo pregabalin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kyle M Kampman, MD
  phone: 215-746-2764
  email: Kampman@pennmedicine.upenn.edu
  last name: Matthew R Taylor
  phone: 215-746-0467
  email: matthew.taylor@pennmedicine.upenn.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pennsylvania
  investigator full name: Kyle Kampman
  investigator title: Professor, Psychiatry
  mesh term: Substance Withdrawal Syndrome
  mesh term: Lofexidine
  mesh term: Clonidine
  mesh term: Pregabalin
  sharing ipd: No