<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/NCT03786120</url>
  </required_header>
  <id_info>
    <org_study_id>Ambien Study</org_study_id>
    <nct_id>NCT03786120</nct_id>
  </id_info>
  <brief_title>The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep</brief_title>
  <official_title>The Efficacy of Lower Dose Zolpidem for Achieving Satisfactory Sleep in Women With Disordered Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vitae Industries, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep difficulties are very common in adults in the U.S. today. Zolpidem (Ambien) is often&#xD;
      prescribed as a first line agent to treat sleep difficulties in patients presenting with&#xD;
      sleep related complaints to Primary Care Practitioners (PCP's). Zolpidem is currently&#xD;
      available in two doses, 10 and 5 mg. These doses were developed in clinical studies carried&#xD;
      out primarily on men. The first dose made clinically available, 10 mg, resulted in morbidity&#xD;
      and mortality in many women because women metabolize Zolpidem at a slower rate than men, thus&#xD;
      the half-life is longer. Women taking Zolpidem often had morning drowsiness, persistent&#xD;
      sleepiness, and difficulty with tasks requiring coordination and judgement, such as motor&#xD;
      vehicle operation. There were a number of well publicized motor vehicle crashes and&#xD;
      fatalities attributed to Zolpidem, mostly among women. The company then produced a 5 mg dose;&#xD;
      however, some women still reported side effects at the lower dose, suggesting persistent drug&#xD;
      levels in the morning, when the drug purportedly should have been cleared from the body.&#xD;
      These women would likely benefit from a lower dose, a dose personalized for their individual&#xD;
      metabolisms and sleep difficulties. Lower doses of Zolpidem are only available from&#xD;
      compounding pharmacies, which are not common, are expensive, do not take many insurances, and&#xD;
      are not offered as an option to most patients. Vitae Industries, Inc. is a start-up tech&#xD;
      company located in Providence, founded by a Brown University graduate, a chemical engineer,&#xD;
      who has developed technology that can provide precisely varied amounts of drug for specific&#xD;
      and variable personalized patient dosing. Personalized medicine is an area of great research&#xD;
      and clinical interest to the medical community at large and the Brown University Medical&#xD;
      School in particular. Brown also has a growing focus on issues of sex and gender in the&#xD;
      rendering of clinical medical care. This technology has the potential to address both of&#xD;
      these areas, providing the possibility of very specific, tailored drug dosing for men and&#xD;
      women. This research was developed as a proof of concept study which will be carried out as a&#xD;
      collaboration between Brown University Medical School/Lifespan physicians and the technical&#xD;
      staff at Vitae Industries, Inc.. This work will be foundational and will serve as the medical&#xD;
      and scientific justification for Vitae Industry's providing patient specific dosing of&#xD;
      medications. For the purposes of this study, the medication to be tested, Zolpidem (Ambien)&#xD;
      will be compounded by a licensed compounding Rhode Island pharmacy, PhusionRx, using&#xD;
      standardized approaches to compounding and formulating pharmaceutical products. This study&#xD;
      will use low doses of Zolpidem formulated by the licensed compounding pharmacy, PhusionRx.&#xD;
      The investigators will provide graduated doses of Zolpidem to women participants meeting&#xD;
      inclusion criteria who present to their primary care physician complaining of difficulty&#xD;
      achieving satisfactory sleep. Participants will start at a dose of 0.5 mg of Zolpidem. Each&#xD;
      day the quality of their sleep will be assessed by self-report. If they have not achieved&#xD;
      satisfactory sleep at the starting dose of 0.5 mg, the will increase their dose daily by 0.5&#xD;
      mg until they reach the standard 5 mg dose or satisfactory sleep is achieved.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>7 days</time_frame>
    <description>This will be based on the sleep journal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>7 days</time_frame>
    <description>Including daytime drowsiness, night walking/eating</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sleep Disorder</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>First 25 subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>Second cohort of 25 subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zolpidem</intervention_name>
    <description>PO sleep aid in various doses</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Health Women with Disordered Sleep&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biologically female&#xD;
&#xD;
          -  age 18-65&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  difficulty sleeping&#xD;
&#xD;
        Exclusion Critieria:&#xD;
&#xD;
          -  diagnosed significant cardiac, pulmonary, neuromuscular, hepatic, renal or major&#xD;
             psychiatric disease (as ascertained by the study physicians)&#xD;
&#xD;
          -  diagnosed sleep pathology such as sleep apnea or prior work-up for sleep pathology&#xD;
&#xD;
          -  recent (two weeks prior) treatment of any kind for sleep disorder including herbal or&#xD;
             over the counter treatments, psychiatric medications including anxiolytics except for&#xD;
             SSRI's.&#xD;
&#xD;
          -  pregnant or trying to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Becker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lifespan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angela Jarman, MD MPH</last_name>
    <phone>9196327961</phone>
    <email>angela.jarman@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>rhode island Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Jarman</last_name>
      <phone>919-632-7961</phone>
      <email>angela.jarman@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Angela Jarman</investigator_full_name>
    <investigator_title>Teaching Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zolpidem</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 7, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT03786120/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03786120
org study id: Ambien Study
nct id: NCT03786120
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
Sleep difficulties are very common in adults in the U.S. today. Zolpidem (Ambien) is often
      prescribed as a first line agent to treat sleep difficulties in patients presenting with
      sleep related complaints to Primary Care Practitioners (PCP's). Zolpidem is currently
      available in two doses, 10 and 5 mg. These doses were developed in clinical studies carried
      out primarily on men. The first dose made clinically available, 10 mg, resulted in morbidity
      and mortality in many women because women metabolize Zolpidem at a slower rate than men, thus
      the half-life is longer. Women taking Zolpidem often had morning drowsiness, persistent
      sleepiness, and difficulty with tasks requiring coordination and judgement, such as motor
      vehicle operation. There were a number of well publicized motor vehicle crashes and
      fatalities attributed to Zolpidem, mostly among women. The company then produced a 5 mg dose;
      however, some women still reported side effects at the lower dose, suggesting persistent drug
      levels in the morning, when the drug purportedly should have been cleared from the body.
      These women would likely benefit from a lower dose, a dose personalized for their individual
      metabolisms and sleep difficulties. Lower doses of Zolpidem are only available from
      compounding pharmacies, which are not common, are expensive, do not take many insurances, and
      are not offered as an option to most patients. Vitae Industries, Inc. is a start-up tech
      company located in Providence, founded by a Brown University graduate, a chemical engineer,
      who has developed technology that can provide precisely varied amounts of drug for specific
      and variable personalized patient dosing. Personalized medicine is an area of great research
      and clinical interest to the medical community at large and the Brown University Medical
      School in particular. Brown also has a growing focus on issues of sex and gender in the
      rendering of clinical medical care. This technology has the potential to address both of
      these areas, providing the possibility of very specific, tailored drug dosing for men and
      women. This research was developed as a proof of concept study which will be carried out as a
      collaboration between Brown University Medical School/Lifespan physicians and the technical
      staff at Vitae Industries, Inc.. This work will be foundational and will serve as the medical
      and scientific justification for Vitae Industry's providing patient specific dosing of
      medications. For the purposes of this study, the medication to be tested, Zolpidem (Ambien)
      will be compounded by a licensed compounding Rhode Island pharmacy, PhusionRx, using
      standardized approaches to compounding and formulating pharmaceutical products. This study
      will use low doses of Zolpidem formulated by the licensed compounding pharmacy, PhusionRx.
      The investigators will provide graduated doses of Zolpidem to women participants meeting
      inclusion criteria who present to their primary care physician complaining of difficulty
      achieving satisfactory sleep. Participants will start at a dose of 0.5 mg of Zolpidem. Each
      day the quality of their sleep will be assessed by self-report. If they have not achieved
      satisfactory sleep at the starting dose of 0.5 mg, the will increase their dose daily by 0.5
      mg until they reach the standard 5 mg dose or satisfactory sleep is achieved.
observational model: Cohort
time perspective: Prospective
measure: Sleep Quality
time frame: 7 days
description: This will be based on the sleep journal
measure: Side Effects
time frame: 7 days
description: Including daytime drowsiness, night walking/eating
arm group label: 1
description: First 25 subjects
arm group label: 2
description: Second cohort of 25 subjects
intervention type: Drug
intervention name: Zolpidem
description: PO sleep aid in various doses
arm group label: 1
arm group label: 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Becker, MD
role: Principal Investigator
affiliation: Lifespan
last name: Angela Jarman, MD MPH
phone: 9196327961
email: angela.jarman@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Angela Jarman
investigator title: Teaching Fellow
mesh term: Sleep Wake Disorders
mesh term: Zolpidem
sharing ipd: No
provided document: 