<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/NCT01702532</url>
  </required_header>
  <id_info>
    <org_study_id>RH01589</org_study_id>
    <nct_id>NCT01702532</nct_id>
  </id_info>
  <brief_title>Nicotine Mouth Film for Craving Relief.</brief_title>
  <official_title>A Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Film and Nicotine Lozenge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this&#xD;
      study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint&#xD;
      nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model.&#xD;
      The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and&#xD;
      the manipulations required to light a cigarette. The smokers will be denied access to&#xD;
      cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine&#xD;
      withdrawal and an increase level of cigarette craving.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds</measure>
    <time_frame>Pre-dosing post-provocation to 50 seconds</time_frame>
    <description>Participants completed a cigarette craving assessment consisting of the following five items: &quot;I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes</measure>
    <time_frame>Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes</time_frame>
    <description>Participants completed a cigarette craving assessment consisting of the following five items: &quot;I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Nicotine Mouth Film</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mint nicotine mouth film, buccal administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicotine Lozenge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nicotine lozenge, buccal administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine</intervention_name>
    <description>Comparison of different dosage forms of nicotine</description>
    <arm_group_label>Nicotine Lozenge</arm_group_label>
    <arm_group_label>Nicotine Mouth Film</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI within the range of 19-35 kg/m2;&#xD;
&#xD;
          -  Current cigarette smokers who have smoked regularly daily for at least a year,&#xD;
&#xD;
          -  Participants who smoke their first cigarette more than 30 minutes after waking up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to nicotine (or closely related&#xD;
             compounds) or any of the stated ingredients in formulation.&#xD;
&#xD;
          -  Any participant whose CO level rises during the sequestration period (i.e., the&#xD;
             subject's two expired CO assessments immediately prior to the provoked craving&#xD;
             paradigm are higher than the mean baseline CO assessment) and, in the opinion of the&#xD;
             investigator, may have smoked during that time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Los Angeles Clinical Trials</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates, Inc.</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>December 12, 2013</results_first_submitted>
  <results_first_submitted_qc>December 12, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 30, 2014</results_first_posted>
  <last_update_submitted>December 12, 2013</last_update_submitted>
  <last_update_submitted_qc>December 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>provoked craving</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited at the clinical site.</recruitment_details>
      <pre_assignment_details>A total of 386 participants were screened of which 322 subjects were randomized into the study. Sixty subjects were screen failures, Two subjects withdrew consent and an additional 2 subjects were not randomized due to other reasons.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nicotine Mouth Film 2.5 mg</title>
          <description>Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).</description>
        </group>
        <group group_id="P2">
          <title>Nicotine Lozenge 2 mg</title>
          <description>Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="160">One subject randomized but did not receive the study treatment.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nicotine Mouth Film 2.5 mg</title>
          <description>Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).</description>
        </group>
        <group group_id="B2">
          <title>Nicotine Lozenge 2 mg</title>
          <description>Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).</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="161"/>
            <count group_id="B2" value="160"/>
            <count group_id="B3" value="321"/>
          </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="39.0" spread="12.91"/>
                    <measurement group_id="B2" value="39.8" spread="12.64"/>
                    <measurement group_id="B3" value="39.4" spread="12.76"/>
                  </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="89"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds</title>
        <description>Participants completed a cigarette craving assessment consisting of the following five items: &quot;I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.</description>
        <time_frame>Pre-dosing post-provocation to 50 seconds</time_frame>
        <population>All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.</population>
        <group_list>
          <group group_id="O1">
            <title>Nicotine Mouth Film 2.5 mg</title>
            <description>Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).</description>
          </group>
          <group group_id="O2">
            <title>Nicotine Lozenge 2 mg</title>
            <description>Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes)</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds</title>
          <description>Participants completed a cigarette craving assessment consisting of the following five items: &quot;I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.</description>
          <population>All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.</population>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.15" lower_limit="-16.90" upper_limit="-11.41"/>
                    <measurement group_id="O2" value="-9.26" lower_limit="-12.01" upper_limit="-6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0141</p_value>
            <p_value_desc>The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed</method_desc>
            <param_type>LS Means Difference</param_type>
            <param_value>-4.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.80</ci_lower_limit>
            <ci_upper_limit>-0.99</ci_upper_limit>
            <estimate_desc>Comment: The confidence interval is for the difference between treatments groups</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes</title>
        <description>Participants completed a cigarette craving assessment consisting of the following five items: &quot;I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .</description>
        <time_frame>Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nicotine Mouth Film 2.5 mg</title>
            <description>Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).</description>
          </group>
          <group group_id="O2">
            <title>Nicotine Lozenge 2 mg</title>
            <description>Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 - 30 minutes).</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes</title>
          <description>Participants completed a cigarette craving assessment consisting of the following five items: &quot;I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .</description>
          <units>mm</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Difference in VAS Score at 3 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.02" lower_limit="-30.64" upper_limit="-23.39"/>
                    <measurement group_id="O2" value="-20.30" lower_limit="-23.93" upper_limit="-16.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 5 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.95" lower_limit="-37.88" upper_limit="-30.02"/>
                    <measurement group_id="O2" value="-28.33" lower_limit="-32.27" upper_limit="-24.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 7 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.13" lower_limit="-43.20" upper_limit="-35.05"/>
                    <measurement group_id="O2" value="-34.14" lower_limit="-38.23" upper_limit="-30.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 10 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.94" lower_limit="-45.08" upper_limit="-36.80"/>
                    <measurement group_id="O2" value="-39.16" lower_limit="-43.31" upper_limit="-35.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 15 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.19" lower_limit="-46.42" upper_limit="-37.97"/>
                    <measurement group_id="O2" value="-42.30" lower_limit="-46.53" upper_limit="-38.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 20 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.43" lower_limit="-46.77" upper_limit="-38.09"/>
                    <measurement group_id="O2" value="-45.23" lower_limit="-49.58" upper_limit="-40.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 25 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.16" lower_limit="-47.55" upper_limit="-38.78"/>
                    <measurement group_id="O2" value="-46.27" lower_limit="-50.67" upper_limit="-41.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difference in VAS Score at 30 Minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.54" lower_limit="-48.11" upper_limit="-38.97"/>
                    <measurement group_id="O2" value="-47.48" lower_limit="-52.06" upper_limit="-42.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from the start of the sequestration period upto 5 days after the last treament</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nicotine Mouth Film 2.5 mg</title>
          <description>Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).</description>
        </group>
        <group group_id="E2">
          <title>Nicotine Lozenge 2 mg</title>
          <description>Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="6" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Epigastric Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Throat Irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="160"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT01702532
org study id: RH01589
nct id: NCT01702532
lead sponsor: 
has dmc: No
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this
      study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint
      nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model.
      The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and
      the manipulations required to light a cigarette. The smokers will be denied access to
      cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine
      withdrawal and an increase level of cigarette craving.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds
time frame: Pre-dosing post-provocation to 50 seconds
description: Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.
measure: The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes
time frame: Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes
description: Participants completed a cigarette craving assessment consisting of the following five items: "I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time .
arm group label: Nicotine Mouth Film
arm group type: Experimental
description: mint nicotine mouth film, buccal administration
arm group label: Nicotine Lozenge
arm group type: Active Comparator
description: nicotine lozenge, buccal administration
intervention type: Drug
intervention name: Nicotine
description: Comparison of different dosage forms of nicotine
arm group label: Nicotine Lozenge
arm group label: Nicotine Mouth Film
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 