<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/NCT03017430</url>
  </required_header>
  <id_info>
    <org_study_id>BRPI-PGBL-OW01</org_study_id>
    <nct_id>NCT03017430</nct_id>
  </id_info>
  <brief_title>Pregabalin for Opiate Withdrawal Syndrome</brief_title>
  <official_title>Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Petersburg Bekhterev Research Psychoneurological Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Petersburg Bekhterev Research Psychoneurological Institute</source>
  <brief_summary>
    <textblock>
      It is a single blind randomized symptom triggered study to assess efficacy and safety of&#xD;
      pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs.&#xD;
      clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: Single-blind randomized symptom-regulated protocol with an active control.&#xD;
      Eighty patients admitted to an inpatient addiction treatment program will be randomly&#xD;
      assigned to two groups. The first group (N=40) receives up to 600 mg a day of Pregabalin for&#xD;
      six days along with symptomatic therapy that is divided into basic treatment that is given to&#xD;
      all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as&#xD;
      determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac,&#xD;
      Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine). The second group (N=&#xD;
      40) receives up to 600 micrograms of Clonidine a day as the main treatment along with the&#xD;
      same basic and symptomatic regimen. Opiate withdrawal severity, craving, sleep disturbance,&#xD;
      anxiety and depression, as well as general clinical impressions and side effects are assessed&#xD;
      daily by psychiatrists who are blind to patients' group assignment using internationally&#xD;
      validated quantitative psychometric instruments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients completed detoxification</measure>
    <time_frame>7 days</time_frame>
    <description>Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of opiod withdrawal</measure>
    <time_frame>7 days</time_frame>
    <description>Compares changes of severity of opioid withdrawal syndrome in two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Ketorolac administered</measure>
    <time_frame>7 days</time_frame>
    <description>Compares amount of Ketorolac administered under the symptom triggered protocol (per patient's request of physician's judgement) in two arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and severity of adverse events</measure>
    <time_frame>7 days</time_frame>
    <description>Compares number and severity of adverse events in two treatment arms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Craving for opiates</measure>
    <time_frame>7 days</time_frame>
    <description>Craving for opiates will be measured with the visual analog scale. Compares craving for opiates in two treatment arms during detoxification.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Opioid Withdrawal</condition>
  <arm_group>
    <arm_group_label>Pregabalin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group (N= 40) receives up to 600 mg a day of Pregabalin for six-seven days along with symptomatic therapy that is divided into basic treatment that is given to all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clonidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group (N= 40) receives up to 600 micrograms of Clonidine a day for six-seven days along with symptomatic therapy that is divided into basic treatment that is given to all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)..</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).</description>
    <arm_group_label>Pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clonidine</intervention_name>
    <description>Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)</description>
    <arm_group_label>Clonidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxylamin</intervention_name>
    <arm_group_label>Clonidine</arm_group_label>
    <arm_group_label>Pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)</intervention_name>
    <arm_group_label>Clonidine</arm_group_label>
    <arm_group_label>Pregabalin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Opioid Use Disorders; Opioid Withdrawal Syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric and somatic disorders, other Substance Use Disorders (except&#xD;
             tobacco)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St.-Petersburg Bekhterev Reserach Psychoneurological Institute</name>
      <address>
        <city>St.-Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>April 4, 2020</last_update_submitted>
  <last_update_submitted_qc>April 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</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>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Phenazepam</mesh_term>
    <mesh_term>Clonidine</mesh_term>
    <mesh_term>Pregabalin</mesh_term>
    <mesh_term>Metoclopramide</mesh_term>
    <mesh_term>Loperamide</mesh_term>
    <mesh_term>Antidiarrheals</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/NCT03017430
org study id: BRPI-PGBL-OW01
nct id: NCT03017430
lead sponsor: 
It is a single blind randomized symptom triggered study to assess efficacy and safety of
      pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs.
      clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.
Study design: Single-blind randomized symptom-regulated protocol with an active control.
      Eighty patients admitted to an inpatient addiction treatment program will be randomly
      assigned to two groups. The first group (N=40) receives up to 600 mg a day of Pregabalin for
      six days along with symptomatic therapy that is divided into basic treatment that is given to
      all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as
      determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac,
      Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine). The second group (N=
      40) receives up to 600 micrograms of Clonidine a day as the main treatment along with the
      same basic and symptomatic regimen. Opiate withdrawal severity, craving, sleep disturbance,
      anxiety and depression, as well as general clinical impressions and side effects are assessed
      daily by psychiatrists who are blind to patients' group assignment using internationally
      validated quantitative psychometric instruments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of patients completed detoxification
time frame: 7 days
description: Compares number of patients that finish treatment of opioid withdrawal syndrome (detoxification) in two treatment arms.
measure: Severity of opiod withdrawal
time frame: 7 days
description: Compares changes of severity of opioid withdrawal syndrome in two arms
measure: Amount of Ketorolac administered
time frame: 7 days
description: Compares amount of Ketorolac administered under the symptom triggered protocol (per patient's request of physician's judgement) in two arms.
measure: Number and severity of adverse events
time frame: 7 days
description: Compares number and severity of adverse events in two treatment arms
measure: Craving for opiates
time frame: 7 days
description: Craving for opiates will be measured with the visual analog scale. Compares craving for opiates in two treatment arms during detoxification.
arm group label: Pregabalin
arm group type: Experimental
description: This group (N= 40) receives up to 600 mg a day of Pregabalin for six-seven days along with symptomatic therapy that is divided into basic treatment that is given to all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).
arm group label: Clonidine
arm group type: Active Comparator
description: This group (N= 40) receives up to 600 micrograms of Clonidine a day for six-seven days along with symptomatic therapy that is divided into basic treatment that is given to all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)..
intervention type: Drug
intervention name: Pregabalin
description: Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).
arm group label: Pregabalin
intervention type: Drug
intervention name: Clonidine
description: Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
arm group label: Clonidine
intervention type: Drug
intervention name: Doxylamin
arm group label: Clonidine
arm group label: Pregabalin
intervention type: Drug
intervention name: Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
arm group label: Clonidine
arm group label: Pregabalin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Substance Withdrawal Syndrome
mesh term: Ketorolac
mesh term: Phenazepam
mesh term: Clonidine
mesh term: Pregabalin
mesh term: Metoclopramide
mesh term: Loperamide
mesh term: Antidiarrheals