<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/NCT01685073</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00068969</org_study_id>
    <secondary_id>U01DA031784</secondary_id>
    <nct_id>NCT01685073</nct_id>
  </id_info>
  <brief_title>The Role of Sleep in the Treatment of Cannabis Use Disorders</brief_title>
  <official_title>The Role of Sleep in the Treatment of Cannabis Use Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The number of people seeking treatment for marijuana-related problems is on the rise, yet&#xD;
      there is no currently accepted medication proven to help them quit. Frequent marijuana users&#xD;
      have reported that they have trouble sleeping when they try to quit, and that the loss of&#xD;
      sleep can lead to relapse. This research is designed to measure the severity of sleep&#xD;
      problems in people as they are trying to quit heavy use of marijuana, and to investigate&#xD;
      whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to&#xD;
      stop using marijuana.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed</measure>
    <time_frame>Week 1 of treatment</time_frame>
    <description>Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing</measure>
    <time_frame>Week 12</time_frame>
    <description>Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH &lt;50ng/mL via EIA.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">127</enrollment>
  <condition>Drug Addiction</condition>
  <arm_group>
    <arm_group_label>Zolpidem</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zolpidem extended-release</intervention_name>
    <description>nightly administration of zolpidem extended-release</description>
    <arm_group_label>Zolpidem</arm_group_label>
    <other_name>Ambien CR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MET/CBT</intervention_name>
    <description>a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Zolpidem</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-55 years.&#xD;
&#xD;
          2. Recent problematic use of cannabis&#xD;
&#xD;
          3. Cannabis use impacts sleep&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Dependent on drugs other than cannabis or nicotine, or current Axis I psychiatric&#xD;
             disorder&#xD;
&#xD;
          2. Moderate sleep apnea or periodic limb movement disorder&#xD;
&#xD;
          3. Pregnant, breast feeding, or planning to become pregnant within the next 3 months&#xD;
&#xD;
          4. Current condition associated with severe cognitive/social impairment&#xD;
&#xD;
          5. Allergy to any ingredient in extended-release zolpidem or prior adverse reaction to&#xD;
             zolpidem&#xD;
&#xD;
          6. Current use of drugs that affect metabolism via cytochrome P450 or current illness&#xD;
             resulting in severe hepatic impairment&#xD;
&#xD;
          7. Current use of hypnotic medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ryan Vandrey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>May 1, 2019</results_first_submitted>
  <results_first_submitted_qc>May 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 22, 2019</results_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>marijuana</keyword>
  <keyword>cannabis</keyword>
  <keyword>treatment</keyword>
  <keyword>insomnia</keyword>
  <keyword>relapse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related 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>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 15, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT01685073/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zolpidem</title>
          <description>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder&#xD;
Zolpidem extended-release: nightly administration of zolpidem extended-release&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62">Randomized</participants>
                <participants group_id="P2" count="65">Randomized</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32">Retained in treatment through 12 weeks</participants>
                <participants group_id="P2" count="33">Retained in treatment through 12 weeks</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Zolpidem</title>
          <description>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder&#xD;
Zolpidem extended-release: nightly administration of zolpidem extended-release&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
            <count group_id="B2" value="65"/>
            <count group_id="B3" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" spread="9"/>
                    <measurement group_id="B2" value="32" spread="9"/>
                    <measurement group_id="B3" value="31" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco Smoking Status</title>
          <description>Tobacco smoking status count was for participants who answered YES to tobacco smoking</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed</title>
        <description>Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.</description>
        <time_frame>Week 1 of treatment</time_frame>
        <population>Sleep data was not obtained for 12 people in the zolpidem group and 14 people in the placebo group at Week 1, and could not be included in this analysis. These individuals dropped out of the study or were lost to follow-up by the time of data collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Zolpidem</title>
            <description>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder&#xD;
Zolpidem extended-release: nightly administration of zolpidem extended-release&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed</title>
          <description>Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.</description>
          <population>Sleep data was not obtained for 12 people in the zolpidem group and 14 people in the placebo group at Week 1, and could not be included in this analysis. These individuals dropped out of the study or were lost to follow-up by the time of data collection.</population>
          <units>percentage of time asleep while in bed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="16"/>
                    <measurement group_id="O2" value="74" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing</title>
        <description>Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH &lt;50ng/mL via EIA.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zolpidem</title>
            <description>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder&#xD;
Zolpidem extended-release: nightly administration of zolpidem extended-release&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing</title>
          <description>Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH &lt;50ng/mL via EIA.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Negative urine test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive urine test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Zolpidem</title>
          <description>Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder&#xD;
Zolpidem extended-release: nightly administration of zolpidem extended-release&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder&#xD;
MET/CBT: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke, cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="62"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>emesis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="62"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>toothache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="62"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Cold symptoms</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="62"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Sleep Difficulties</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There was a significant number of participant drop-outs in both study arms</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ryan Vandrey, PhD</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>410-550-4036</phone>
      <email>rvandrey@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01685073
org study id: NA_00068969
secondary id: U01DA031784
nct id: NCT01685073
lead sponsor: 
collaborator: 
has dmc: Yes
The number of people seeking treatment for marijuana-related problems is on the rise, yet
      there is no currently accepted medication proven to help them quit. Frequent marijuana users
      have reported that they have trouble sleeping when they try to quit, and that the loss of
      sleep can lead to relapse. This research is designed to measure the severity of sleep
      problems in people as they are trying to quit heavy use of marijuana, and to investigate
      whether extended-release zolpidem (Ambien CR®) can improve quit rates among people trying to
      stop using marijuana.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed
time frame: Week 1 of treatment
description: Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.
measure: Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing
time frame: Week 12
description: Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.
arm group label: Zolpidem
arm group type: Experimental
description: Participants receive active zolpidem nightly in addition to psychosocial therapy during 12-week treatment of a cannabis use disorder
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants receive placebo medication during a 12-week psychosocial treatment for a cannabis use disorder
intervention type: Drug
intervention name: Zolpidem extended-release
description: nightly administration of zolpidem extended-release
arm group label: Zolpidem
other name: Ambien CR
intervention type: Behavioral
intervention name: MET/CBT
description: a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
arm group label: Placebo
arm group label: Zolpidem
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ryan Vandrey, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Zolpidem
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There was a significant number of participant drop-outs in both study arms
point of contact: 