<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/NCT01730846</url>
  </required_header>
  <id_info>
    <org_study_id>1111009293</org_study_id>
    <secondary_id>R21DA033597</secondary_id>
    <nct_id>NCT01730846</nct_id>
  </id_info>
  <brief_title>Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?</brief_title>
  <official_title>Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale 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>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine whether doxazosin will attenuate the ability of&#xD;
      stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants&#xD;
      will participate in a smoking cessation attempt after the laboratory sessions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Latency (Min) to Initiate Ad-lib Smoking Session</measure>
    <time_frame>0 up to 50 minutes (Delay Period)</time_frame>
    <description>Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Cigarettes Smoked During Ad-lib Session</measure>
    <time_frame>60 minutes (ad-lib smoking period)</time_frame>
    <description>Number of cigarettes smoked during the stress and neutral ad-lib smoking period.&#xD;
Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Doxazosin 4mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>doxazosin 4mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doxazosin 8mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>doxazosin 8mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxazosin 4mg/day</intervention_name>
    <description>4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
    <arm_group_label>Doxazosin 4mg/day</arm_group_label>
    <other_name>Cardura</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxazosin 8mg/day</intervention_name>
    <description>8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
    <arm_group_label>Doxazosin 8mg/day</arm_group_label>
    <other_name>Cardura</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-60&#xD;
&#xD;
          -  Able to read and write English&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Motivated to Quit Smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant current medical conditions that would contraindicate smoking&#xD;
&#xD;
          -  Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or&#xD;
             dependence of other substances, other than nicotine dependence or alcohol abuse&#xD;
&#xD;
          -  Positive test results at intake appointment on urine drug screens for illicit drugs&#xD;
&#xD;
          -  Past 30 day use of psychoactive drugs including anxiolytics and antidepressants&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
&#xD;
          -  Suicidal, homicidal or evidence of current severe mental illness such as&#xD;
             schizophrenia, bipolar disorder or major depression, or anxiety disorders&#xD;
&#xD;
          -  Participants who have donated blood within the past 6 weeks&#xD;
&#xD;
          -  Individuals who are currently taking other medications prescribed for smoking&#xD;
             cessation&#xD;
&#xD;
          -  Specific exclusions for administration of doxazosin or any alpha blocker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherry A McKee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Center for Clinical Investigations, Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>November 20, 2017</results_first_submitted>
  <results_first_submitted_qc>November 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2017</results_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Sherry McKee</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>smoking lapse behavior</keyword>
  <keyword>smoking cessation</keyword>
  <keyword>doxazosin</keyword>
  <keyword>medication effect on smoking lapse behavior</keyword>
  <keyword>medication effect on smoking cessation</keyword>
  <keyword>stress</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxazosin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo controlled</description>
        </group>
        <group group_id="P2">
          <title>4mg/Day</title>
          <description>doxazosin 4mg/day&#xD;
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
        </group>
        <group group_id="P3">
          <title>8mg/Day</title>
          <description>doxazosin 8mg/day&#xD;
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo controlled</description>
        </group>
        <group group_id="B2">
          <title>4mg/Day</title>
          <description>doxazosin 4mg/day&#xD;
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
        </group>
        <group group_id="B3">
          <title>8mg/Day</title>
          <description>doxazosin 8mg/day&#xD;
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
        </group>
        <group group_id="B4">
          <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="11"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="13"/>
            <count group_id="B4" value="35"/>
          </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="37.36" spread="9.29"/>
                    <measurement group_id="B2" value="34.82" spread="10.85"/>
                    <measurement group_id="B3" value="34.23" spread="9.83"/>
                    <measurement group_id="B4" value="35.40" spread="9.80"/>
                  </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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Latency (Min) to Initiate Ad-lib Smoking Session</title>
        <description>Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.</description>
        <time_frame>0 up to 50 minutes (Delay Period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo controlled</description>
          </group>
          <group group_id="O2">
            <title>4mg/Day</title>
            <description>doxazosin 4mg/day&#xD;
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
          </group>
          <group group_id="O3">
            <title>8mg/Day</title>
            <description>doxazosin 8mg/day&#xD;
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Latency (Min) to Initiate Ad-lib Smoking Session</title>
          <description>Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.304" spread="7.407"/>
                    <measurement group_id="O2" value="32.128" spread="7.494"/>
                    <measurement group_id="O3" value="27.557" spread="6.409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.474" spread="8.312"/>
                    <measurement group_id="O2" value="26.790" spread="8.410"/>
                    <measurement group_id="O3" value="23.776" spread="7.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cigarettes Smoked During Ad-lib Session</title>
        <description>Number of cigarettes smoked during the stress and neutral ad-lib smoking period.&#xD;
Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.</description>
        <time_frame>60 minutes (ad-lib smoking period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo controlled</description>
          </group>
          <group group_id="O2">
            <title>4mg/Day</title>
            <description>doxazosin 4mg/day&#xD;
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
          </group>
          <group group_id="O3">
            <title>8mg/Day</title>
            <description>doxazosin 8mg/day&#xD;
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cigarettes Smoked During Ad-lib Session</title>
          <description>Number of cigarettes smoked during the stress and neutral ad-lib smoking period.&#xD;
Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.</description>
          <units>number of cigarettes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.331" spread="0.563"/>
                    <measurement group_id="O2" value="1.890" spread="0.561"/>
                    <measurement group_id="O3" value="1.813" spread="0.493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.139" spread="0.397"/>
                    <measurement group_id="O2" value="1.866" spread="0.396"/>
                    <measurement group_id="O3" value="1.688" spread="0.348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Titration period (3 weeks)</time_frame>
      <desc>Adverse events were assessed twice weekly with a symptom list during the 3-week titration period</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo controlled</description>
        </group>
        <group group_id="E2">
          <title>4mg/Day</title>
          <description>doxazosin 4mg/day&#xD;
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
        </group>
        <group group_id="E3">
          <title>8mg/Day</title>
          <description>doxazosin 8mg/day&#xD;
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="4" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fast heartbeat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abnormal vision</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Impotence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Increased sweating</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="13"/>
              </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>
    <point_of_contact>
      <name_or_title>Sherry McKee, PhD</name_or_title>
      <organization>Yale School of Medicine</organization>
      <phone>203-737-3529</phone>
      <email>sherry.mckee@yale.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/NCT01730846
org study id: 1111009293
secondary id: R21DA033597
nct id: NCT01730846
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine whether doxazosin will attenuate the ability of
      stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants
      will participate in a smoking cessation attempt after the laboratory sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Latency (Min) to Initiate Ad-lib Smoking Session
time frame: 0 up to 50 minutes (Delay Period)
description: Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.
measure: Number of Cigarettes Smoked During Ad-lib Session
time frame: 60 minutes (ad-lib smoking period)
description: Number of cigarettes smoked during the stress and neutral ad-lib smoking period.
Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.
arm group label: Doxazosin 4mg/day
arm group type: Experimental
description: doxazosin 4mg/day
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo control
arm group label: Doxazosin 8mg/day
arm group type: Experimental
description: doxazosin 8mg/day
intervention type: Drug
intervention name: Doxazosin 4mg/day
description: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
arm group label: Doxazosin 4mg/day
other name: Cardura
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Doxazosin 8mg/day
description: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
arm group label: Doxazosin 8mg/day
other name: Cardura
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherry A McKee, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Sherry McKee
investigator title: Associate Professor of Psychiatry
mesh term: Doxazosin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 