<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/NCT01716377</url>
  </required_header>
  <id_info>
    <org_study_id>104106</org_study_id>
    <nct_id>NCT01716377</nct_id>
  </id_info>
  <brief_title>Healing With Venlafaxine After Injury (HELP)</brief_title>
  <acronym>HELP</acronym>
  <official_title>Healing With Venlafaxine After Injury: A Randomized Clinical Trial of Venlafaxine Following Motor Vehicle Collision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayday Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baystate Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine&#xD;
      administration in reducing acute and chronic musculoskeletal pain in individuals presenting&#xD;
      to the ED for evaluation after motor vehicle collision.&#xD;
&#xD;
      Participants: Participants will consist of 60 patients between the ages of 18-50 who present&#xD;
      to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score&#xD;
      &gt; 6 will be screened for further eligibility.&#xD;
&#xD;
      Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60&#xD;
      high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of&#xD;
      venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed&#xD;
      during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks,&#xD;
      4 months, and 6 months post-MVC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Results from both animal and human studies suggest that treatment with the&#xD;
      serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In&#xD;
      addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress&#xD;
      disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing&#xD;
      pain persistence after trauma.&#xD;
&#xD;
      This phase IIB pilot trial will screen patients presenting to the ED after MVC for the&#xD;
      presence of severe axial pain (&gt;4 on a 0-10 numeric rating scale). Sixty of these &quot;high risk&quot;&#xD;
      patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to&#xD;
      decrease acute and persistent musculoskeletal axial pain will be assessed.&#xD;
&#xD;
      Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine&#xD;
      intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients&#xD;
      presenting to the ED after minor MVC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average neck pain</measure>
    <time_frame>0-31 Days</time_frame>
    <description>The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic neck pain</measure>
    <time_frame>Study day 38 through 6 months</time_frame>
    <description>The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Venlafaxine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venlafaxine</intervention_name>
    <description>Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Venlafaxine</arm_group_label>
    <other_name>Effexor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 59&#xD;
&#xD;
          -  Presents to ED within 24 hours of MVC&#xD;
&#xD;
          -  ED axial pain score greater than or equal to 4 (0-10 NRS)&#xD;
&#xD;
          -  Clinically sober&#xD;
&#xD;
          -  Willing to provide a blood sample&#xD;
&#xD;
          -  Has a telephone&#xD;
&#xD;
          -  Has regular access to Internet and an email address&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Permanent US citizen or has a green card&#xD;
&#xD;
          -  Blood pressure reading(s) in ED that, when considered in the context of patient past&#xD;
             and current history, in the investigator's judgment does not exceed acceptable level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Axial pain score greater than 0 in the past month (0-10 NRS)&#xD;
&#xD;
          -  Clinically unstable&#xD;
&#xD;
          -  Fracture (other than fracture of the phalanges)&#xD;
&#xD;
          -  Substantial soft tissue injury&#xD;
&#xD;
          -  Hepatic failure (acute or chronic)&#xD;
&#xD;
          -  Renal failure (acute or chronic)&#xD;
&#xD;
          -  Coronary artery disease, including previous MI, Angina, PCTA, etc.&#xD;
&#xD;
          -  History of glaucoma&#xD;
&#xD;
          -  Previous congestive heart failure&#xD;
&#xD;
          -  History of seizure disorder&#xD;
&#xD;
          -  History of mania or psychotic disorder&#xD;
&#xD;
          -  History of suicidal ideation&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  History and behavior indicates, in the investigator's judgment, that the participant&#xD;
             would likely be noncompliant with the study&#xD;
&#xD;
          -  Any other condition that, in the investigator's judgment, would indicate that the&#xD;
             patient in unsuitable for the study (e.g. might interfere with the study, confound&#xD;
             interpretation, or endanger patient)&#xD;
&#xD;
          -  Currently taking a monoamine oxidase inhibitor&#xD;
&#xD;
          -  Currently taking medication with substantial interaction with venlafaxine, or which&#xD;
             could confound interpretation of study results&#xD;
&#xD;
          -  Breastfeeding&#xD;
&#xD;
          -  If female, either not postmenopausal (having menses within past year), or, if&#xD;
             childbearing potential, positive pregnancy test prior to randomization and not using a&#xD;
             medically acceptable form of contraception&#xD;
&#xD;
          -  Exceeds acceptable chronic daily opioid use prior to MVC&#xD;
&#xD;
          -  Previously on venlafaxine&#xD;
&#xD;
          -  Previous allergic reaction to venlafaxine&#xD;
&#xD;
          -  Antidepressant use within 2 weeks of study start (4 week if Prozac)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel A McLean, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spectrum Health Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten Rindal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory Fermann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Francesca Beaudoin</investigator_full_name>
    <investigator_title>Assistant Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>Neck Pain</keyword>
  <keyword>Musculoskeletal pain</keyword>
  <keyword>Venlafaxine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venlafaxine Hydrochloride</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/NCT01716377
org study id: 104106
nct id: NCT01716377
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Purpose: The purpose of this study is to demonstrate the potential efficacy of venlafaxine
      administration in reducing acute and chronic musculoskeletal pain in individuals presenting
      to the ED for evaluation after motor vehicle collision.

      Participants: Participants will consist of 60 patients between the ages of 18-50 who present
      to the ED within 12 hours post-motor vehicle collision. Patients who report a neck pain score
      > 6 will be screened for further eligibility.

      Procedures (methods): Using a placebo-controlled, randomized, double-blind trial design, 60
      high risk patients will be randomized to venlafaxine vs. placebo in the ED. The ability of
      venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed
      during serial short-term telephone follow-ups as well as more in-depth follow-ups at 6 weeks,
      4 months, and 6 months post-MVC.
Results from both animal and human studies suggest that treatment with the
      serotonin-norepinephrine reuptake inhibitor (SNRIs) venlafaxine may reduce post-MVC pain. In
      addition, venlafaxine has been shown to be beneficial in reducing posttraumatic stress
      disorder (PTSD) symptoms, and in some patients PTSD symptoms may contribute to reinforcing
      pain persistence after trauma.

      This phase IIB pilot trial will screen patients presenting to the ED after MVC for the
      presence of severe axial pain (>4 on a 0-10 numeric rating scale). Sixty of these "high risk"
      patients will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to
      decrease acute and persistent musculoskeletal axial pain will be assessed.

      Results will be used to design a large-scale RCT assessing the efficacy of venlafaxine
      intervention in decreasing acute and persistent musculoskeletal pain in high-risk patients
      presenting to the ED after minor MVC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Average neck pain
time frame: 0-31 Days
description: The primary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) after study drug initiation through Day 31.
measure: Chronic neck pain
time frame: Study day 38 through 6 months
description: The secondary outcome variable is average neck pain (0 - 10 numeric rating pain score recorded from patient) between study day 38 through 6 months.
arm group label: Placebo
arm group type: Placebo Comparator
description: 37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
arm group label: Venlafaxine
arm group type: Active Comparator
description: 37.5mg QD 1 week 75mg QD 1 week 150mg QD 8 weeks 75mg QD 1 week 37.5mg QD 1 week
intervention type: Drug
intervention name: Venlafaxine
description: Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.
arm group label: Placebo
arm group label: Venlafaxine
other name: Effexor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Samuel A McLean, MD, MPH
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Jeffrey Jones, MD
role: Principal Investigator
affiliation: Spectrum Health Hospitals
last name: Kirsten Rindal, MD
role: Principal Investigator
affiliation: University of Rochester
last name: Gregory Fermann, MD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Francesca Beaudoin
investigator title: Assistant Professor of Emergency Medicine
mesh term: Neck Pain
mesh term: Venlafaxine Hydrochloride
sharing ipd: No