<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/NCT03043443</url>
  </required_header>
  <id_info>
    <org_study_id>099-2016</org_study_id>
    <nct_id>NCT03043443</nct_id>
  </id_info>
  <brief_title>Melatonin Use for Sleep Problems in Alcohol Dependent Patients</brief_title>
  <official_title>Melatonin for Alcohol Use Disorder Patients With Sleeping Problems</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol&#xD;
      use disorder and sleep problems will be recruited and assigned randomly to the active&#xD;
      treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for&#xD;
      demographics. Sleeping problems will be the primary outcome of the study, and it will be&#xD;
      measured by the Pittsburgh sleep quality index (PSQI) scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol&#xD;
      use disorder and sleep problems will be recruited and assigned randomly to either Melatonin&#xD;
      or Placebo arms. All subjects will complete some forms on the REDCap system such as contact&#xD;
      information list, concomitant medication, Time Line Follow Back (TLFB), Fagerstrom test for&#xD;
      nicotine dependence (FTND), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI),&#xD;
      AUD criteria, and Alcohol use disorder identification test (AUDIT). Sleeping problems will be&#xD;
      the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality&#xD;
      index (PSQI) scale where score 5 or more indicated a sleeping problem. Women in child-bearing&#xD;
      period will be asked to do a urine pregnancy test to exclude pregnancy. After verifying&#xD;
      eligibility, the participants will come to pick up the medication (Melatonin or placebo)&#xD;
      blister together with a sleep hygiene document and will start taking the medication for 4&#xD;
      weeks. All subjects will then be followed-up at the end of 1 month of treatment and PSQI&#xD;
      score will be measured. This step will be completed either online by sending an email link&#xD;
      through or the participants can come to a personal visit to complete the second PSQI form.&#xD;
      Also, this last visit/email will contain side effects questionnaire, TLFB, BDI, BAI. All the&#xD;
      participants will be required to bring/send back the medication blister pack to do a pill&#xD;
      count and check all the missing pills.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</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>Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PSQI score</measure>
    <time_frame>1 month</time_frame>
    <description>The primary outcome of the study is PSQI score. This will be analyzed by the difference in the global score before and after the use of melatonin versus placebo. Score &gt; 5 indicates a sleep problem.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSQI subscales</measure>
    <time_frame>1 month</time_frame>
    <description>Secondary outcome measures will include the subscales of PSQI: 1) subjective quality of sleep; 2) sleep onset latency; 3) sleep duration; 4) sleep efficiency; 5) presence of sleep disturbances; and 6) presence of daytime disturbances, as an indication of daytime alertness.&#xD;
As according to previous studies, melatonin showed a significant decrease in sleep onset latency and an improvement in daytime alertness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alcohol-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>participants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Melatonin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <description>Natural health product for sleep problems treatment</description>
    <arm_group_label>Melatonin</arm_group_label>
    <other_name>melatonin 5 mg oral tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Lactose containing pills</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Lactose pills</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 19 or older&#xD;
&#xD;
          -  AUD in any stage&#xD;
&#xD;
          -  Sleep problems in the past month&#xD;
&#xD;
          -  PSQI score &gt; 5 at baseline&#xD;
&#xD;
          -  Participants must agree not to use other sleep aid during the study&#xD;
&#xD;
          -  Women capable of becoming pregnant must agree to use contraceptives during study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, lactation or plans to become pregnant during the study timeline.&#xD;
&#xD;
          -  Use of other sleep aid in the past month (either prescribed or over the counter&#xD;
             remedies)&#xD;
&#xD;
          -  Use of benzodiazepines and/or Z- drugs: (zaleplon, zolpidem and zopiclone) in the past&#xD;
             month&#xD;
&#xD;
          -  Known allergy to melatonin&#xD;
&#xD;
          -  Participants taking immunosuppressive drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard LeFoll, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre of addiction and mental health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 1S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Bernard Le Foll</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>sleep</keyword>
  <keyword>Alcohol dependence</keyword>
  <keyword>Melatonin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</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/NCT03043443
org study id: 099-2016
nct id: NCT03043443
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol
      use disorder and sleep problems will be recruited and assigned randomly to the active
      treatment Melatonin or Placebo arms. All subjects will be assessed at baseline for
      demographics. Sleeping problems will be the primary outcome of the study, and it will be
      measured by the Pittsburgh sleep quality index (PSQI) scale.
A double blind Randomized Controlled Trial with two arms will be used. Subjects with Alcohol
      use disorder and sleep problems will be recruited and assigned randomly to either Melatonin
      or Placebo arms. All subjects will complete some forms on the REDCap system such as contact
      information list, concomitant medication, Time Line Follow Back (TLFB), Fagerstrom test for
      nicotine dependence (FTND), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI),
      AUD criteria, and Alcohol use disorder identification test (AUDIT). Sleeping problems will be
      the primary outcome of the study, and it will be measured by the Pittsburgh sleep quality
      index (PSQI) scale where score 5 or more indicated a sleeping problem. Women in child-bearing
      period will be asked to do a urine pregnancy test to exclude pregnancy. After verifying
      eligibility, the participants will come to pick up the medication (Melatonin or placebo)
      blister together with a sleep hygiene document and will start taking the medication for 4
      weeks. All subjects will then be followed-up at the end of 1 month of treatment and PSQI
      score will be measured. This step will be completed either online by sending an email link
      through or the participants can come to a personal visit to complete the second PSQI form.
      Also, this last visit/email will contain side effects questionnaire, TLFB, BDI, BAI. All the
      participants will be required to bring/send back the medication blister pack to do a pill
      count and check all the missing pills.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects with Alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment Melatonin or Placebo arms.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: PSQI score
time frame: 1 month
description: The primary outcome of the study is PSQI score. This will be analyzed by the difference in the global score before and after the use of melatonin versus placebo. Score > 5 indicates a sleep problem.
measure: PSQI subscales
time frame: 1 month
description: Secondary outcome measures will include the subscales of PSQI: 1) subjective quality of sleep; 2) sleep onset latency; 3) sleep duration; 4) sleep efficiency; 5) presence of sleep disturbances; and 6) presence of daytime disturbances, as an indication of daytime alertness.
As according to previous studies, melatonin showed a significant decrease in sleep onset latency and an improvement in daytime alertness.
arm group label: Placebo
arm group type: Placebo Comparator
description: participants will receive placebo 1 capsule/day 1 hour before sleeping for 4 weeks
arm group label: Melatonin
arm group type: Active Comparator
description: participants will receive melatonin 1 capsule (5mg)/day 1 hour before sleeping for 4 weeks
intervention type: Drug
intervention name: Melatonin
description: Natural health product for sleep problems treatment
arm group label: Melatonin
other name: melatonin 5 mg oral tablets
intervention type: Drug
intervention name: Placebo
description: Lactose containing pills
arm group label: Placebo
other name: Lactose pills
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Bernard LeFoll, MD
role: Principal Investigator
affiliation: Centre of addiction and mental health
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Bernard Le Foll
investigator title: Dr.
mesh term: Alcohol-Related Disorders
mesh term: Melatonin
sharing ipd: No