<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/NCT01735279</url>
  </required_header>
  <id_info>
    <org_study_id>Tobacco&amp;Omega</org_study_id>
    <nct_id>NCT01735279</nct_id>
  </id_info>
  <brief_title>Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence</brief_title>
  <official_title>&quot;Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nicotine dependence may prolong the exposure to toxic substances that cause various diseases.&#xD;
      The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty&#xD;
      Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the&#xD;
      modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning&#xD;
      of the mesolimbic and mesocortical pathway, related to the reward system, involved on the&#xD;
      context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows&#xD;
      improvements in several diseases, including mood disorders such as anxiety and depression.&#xD;
      The investigators hypothesis is that supplementation with these fatty acids can restore the&#xD;
      levels of omega-3 and could decrease nicotine dependence. The investigators objective is to&#xD;
      investigate a possible association between increased serum levels of omega-3 and the&#xD;
      reduction in nicotine dependence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: A cigarette has more than 6,000 toxic substances that can cause various&#xD;
      diseases. Nicotine dependence may prolong the exposure to these toxic substances. The Central&#xD;
      Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS)&#xD;
      from omega-3 serie. Omega-3 takes part in several actions, including the modulation of&#xD;
      dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the&#xD;
      mesolimbic and mesocortical pathway, related to the reward system, involved on the context of&#xD;
      nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements&#xD;
      in several diseases, including mood disorders such as anxiety and depression. The&#xD;
      investigators hypothesis is that supplementation with these fatty acids can restore the&#xD;
      levels of omega-3 and could decrease nicotine dependence. Objective: Investigate a possible&#xD;
      association between increased serum levels of omega-3 and the reduction in nicotine&#xD;
      dependence. Material and Methods: In the clinical study, placebo controlled, double-blind,&#xD;
      parallel, randomized, will be administered to 60 volunteers: placebo or fish oil for 90 days.&#xD;
      Psychometric assessments will be carried out, measurements of serum levels of PUFAS, levels&#xD;
      of carbon monoxide (CO) and cotinine in plasma will be done for monitoring the clinical&#xD;
      course. Data Analysis: Repeated measures (ANOVA) for the dependent variables (dependency,&#xD;
      anxiety, depression, motivation, compulsion, dosage of PUFAS, exhaled CO and cotinine) and&#xD;
      independent (groups and time) to check for significant differences. If so, a second ANOVA&#xD;
      with covariates will be conducted. Significance is p &lt;0.05 in all analyzes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment</measure>
    <time_frame>Baseline (prior to the beginning) and after 90 days of the treatment</time_frame>
    <description>The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial.&#xD;
The range for the scale is:&#xD;
very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10&#xD;
So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment</measure>
    <time_frame>At baseline (prior to the beginning of the treatment) and after 90 days of treatment</time_frame>
    <description>The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Eicosapentaenoic Acid (EPA)</measure>
    <time_frame>At baseline (prior to the beginning of the treatment) and after 90 days of treatment</time_frame>
    <description>The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Tobacco Dependence</condition>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will receive 3g per day of mineral oil during 90 days treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omega3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The omega 3 group will receive 3g per day of fish oil during 90 days treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omega 3</intervention_name>
    <description>Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.</description>
    <arm_group_label>Omega3</arm_group_label>
    <other_name>fish oil</other_name>
    <other_name>omega 3 fatty acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>mineral oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine&#xD;
             Dependence (FTND) up to 5 points (FTND &gt; 5); high motivation to stop smoking (accessed&#xD;
             by Richmond Test)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychiatric disorders; taking psychoactive medications; history of alcohol and/or&#xD;
             other drugs abuse or dependence;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José Carlos F. Galduróz, Md PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de São Paulo (UNIFESP)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unidade de Dependência de Drogas (UDED)</name>
      <address>
        <city>São Paulo</city>
        <zip>55</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>January 6, 2016</results_first_submitted>
  <results_first_submitted_qc>September 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2020</results_first_posted>
  <last_update_submitted>September 18, 2020</last_update_submitted>
  <last_update_submitted_qc>September 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Jose Carlos Fernandes Galduroz MD</investigator_full_name>
    <investigator_title>Md PhD</investigator_title>
  </responsible_party>
  <keyword>tobacco dependence</keyword>
  <keyword>tobacco treatment</keyword>
  <keyword>omega 3 series</keyword>
  <keyword>polyunsaturated fatty acids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mineral Oil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to make individual participant data available. The data obtained was analysed and published</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Data were collected in São Paulo/Brazil between January 2013 and August 2013. All participants signed an informed consent prior to the beginning of the study. The participants did not receive any kind of compensation for participation in the study.</recruitment_details>
      <pre_assignment_details>No participants were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses.</description>
        </group>
        <group group_id="P2">
          <title>Omega3</title>
          <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </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="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.</description>
        </group>
        <group group_id="B2">
          <title>Omega3</title>
          <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</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="29"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="58"/>
          </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="47.8" spread="11.5"/>
                    <measurement group_id="B2" value="46.2" spread="11.1"/>
                    <measurement group_id="B3" value="47" spread="11.3"/>
                  </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="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.3" spread="4.7"/>
                    <measurement group_id="B2" value="24.7" spread="3.9"/>
                    <measurement group_id="B3" value="24.5" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment</title>
        <description>The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial.&#xD;
The range for the scale is:&#xD;
very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10&#xD;
So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.</description>
        <time_frame>Baseline (prior to the beginning) and after 90 days of the treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.</description>
          </group>
          <group group_id="O2">
            <title>Omega3</title>
            <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</description>
          </group>
        </group_list>
        <measure>
          <title>Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment</title>
          <description>The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial.&#xD;
The range for the scale is:&#xD;
very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10&#xD;
So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.53" spread="2.01"/>
                    <measurement group_id="O2" value="6.56" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="1.85"/>
                    <measurement group_id="O2" value="5.22" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment</title>
        <description>The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.</description>
        <time_frame>At baseline (prior to the beginning of the treatment) and after 90 days of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.</description>
          </group>
          <group group_id="O2">
            <title>Omega3</title>
            <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment</title>
          <description>The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="747.71" spread="794.00"/>
                    <measurement group_id="O2" value="645.38" spread="757.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="663.93" spread="767.41"/>
                    <measurement group_id="O2" value="1,004.94" spread="1,484.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Eicosapentaenoic Acid (EPA)</title>
        <description>The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.</description>
        <time_frame>At baseline (prior to the beginning of the treatment) and after 90 days of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.</description>
          </group>
          <group group_id="O2">
            <title>Omega3</title>
            <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Eicosapentaenoic Acid (EPA)</title>
          <description>The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.00" spread="67.72"/>
                    <measurement group_id="O2" value="86.76" spread="111.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.39" spread="73.22"/>
                    <measurement group_id="O2" value="174.87" spread="285.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment</title>
        <description>Cotinine is the major metabolite of nicotine, making it its primary metabolite. Cotinine dosage is considered one of the best parameters to distinguish smokers from non-smokers as well as for the nicotine graduation consumption. The traditional cut off value used to distinguish between smokers and non-smokers is 15 ng/mL for dosages from plasma sample</description>
        <time_frame>At baseline (prior to the beginning of the treatment) and after 90 days of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.</description>
          </group>
          <group group_id="O2">
            <title>Omega3</title>
            <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Serum Cotinine at Baseline and After 90 Days of Treatment</title>
          <description>Cotinine is the major metabolite of nicotine, making it its primary metabolite. Cotinine dosage is considered one of the best parameters to distinguish smokers from non-smokers as well as for the nicotine graduation consumption. The traditional cut off value used to distinguish between smokers and non-smokers is 15 ng/mL for dosages from plasma sample</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.20" spread="65.10"/>
                    <measurement group_id="O2" value="129.38" spread="85.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.79" spread="63.26"/>
                    <measurement group_id="O2" value="98.54" spread="61.94"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Test t Student</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>30.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>t-test, 1 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.002</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>t-test, 1 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.4</param_value>
            <ci_n_sides>1-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse event were collected monthly (after 30, 60 and 90 days of the treatment) during the 90 days (treatment time)</time_frame>
      <desc>No adverse event were reported by the participants</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Group n= 29</title>
          <description>placebo capsules 1,000 mg - mineral oil + food dye #2 (simulating the colour of essential fatty acids), taken in 3 daily doses, for 90 days.</description>
        </group>
        <group group_id="E2">
          <title>Omega3 Group n= 29</title>
          <description>omega 3 capsules 1,000 mg fish oil taken as 3 daily doses, for 90 days. Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA</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="00" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="00" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="00" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="00" subjects_at_risk="29"/>
              </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>Md PhD José Carlos F. Galduróz</name_or_title>
      <organization>Department of Psychobiology, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros, São Paulo , Brazil</organization>
      <phone>+55 11 2149 0000</phone>
      <email>galduroz@unifesp.br</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/NCT01735279
org study id: Tobacco&Omega
nct id: NCT01735279
lead sponsor: 
has dmc: No
Nicotine dependence may prolong the exposure to toxic substances that cause various diseases.
      The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty
      Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the
      modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning
      of the mesolimbic and mesocortical pathway, related to the reward system, involved on the
      context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows
      improvements in several diseases, including mood disorders such as anxiety and depression.
      The investigators hypothesis is that supplementation with these fatty acids can restore the
      levels of omega-3 and could decrease nicotine dependence. The investigators objective is to
      investigate a possible association between increased serum levels of omega-3 and the
      reduction in nicotine dependence.
Introduction: A cigarette has more than 6,000 toxic substances that can cause various
      diseases. Nicotine dependence may prolong the exposure to these toxic substances. The Central
      Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty Acids (PUFAS)
      from omega-3 serie. Omega-3 takes part in several actions, including the modulation of
      dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning of the
      mesolimbic and mesocortical pathway, related to the reward system, involved on the context of
      nicotine dependence. Treatment using dietary supplementation with omega-3 shows improvements
      in several diseases, including mood disorders such as anxiety and depression. The
      investigators hypothesis is that supplementation with these fatty acids can restore the
      levels of omega-3 and could decrease nicotine dependence. Objective: Investigate a possible
      association between increased serum levels of omega-3 and the reduction in nicotine
      dependence. Material and Methods: In the clinical study, placebo controlled, double-blind,
      parallel, randomized, will be administered to 60 volunteers: placebo or fish oil for 90 days.
      Psychometric assessments will be carried out, measurements of serum levels of PUFAS, levels
      of carbon monoxide (CO) and cotinine in plasma will be done for monitoring the clinical
      course. Data Analysis: Repeated measures (ANOVA) for the dependent variables (dependency,
      anxiety, depression, motivation, compulsion, dosage of PUFAS, exhaled CO and cotinine) and
      independent (groups and time) to check for significant differences. If so, a second ANOVA
      with covariates will be conducted. Significance is p <0.05 in all analyzes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Fageström Test for Nicotine Dependence Score at Baseline and After 90 Days of the Treatment
time frame: Baseline (prior to the beginning) and after 90 days of the treatment
description: The Fageström Test for Nicotine Dependence is a widely used test to measure the nicotine dependence. This test was chosen to evaluate the possible changes on the nicotine dependence during the clinical trial.
The range for the scale is:
very low (dependence) 0-2 low (dependence) 3-4 moderate (dependence) 5 high (dependence) 6-7 very high (dependence) 8-10
So, lower levels (low scores on the scale) of the FTND measure indicates lower nicotine dependence, and higher levels (high scores on the scales) of the FTND measure indicates higher nicotine dependence.
measure: Concentration of Docosahexaenoic Acid (DHA) at Baseline and After 90 Days of Treatment
time frame: At baseline (prior to the beginning of the treatment) and after 90 days of treatment
description: The polyunsaturated fatty acid Docosahexaenoic acid (DHA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.
measure: Concentration of Eicosapentaenoic Acid (EPA)
time frame: At baseline (prior to the beginning of the treatment) and after 90 days of treatment
description: The polyunsaturated fatty acid Eicosapentaenoic acid (EPA) is one of the main fatty acids omega-3 series. The dosage of these analyte was achieved by means of Liquid Chromatography - Mass Spectrometry Mass Spectrometry - LS-MS-MS.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo group will receive 3g per day of mineral oil during 90 days treatment
arm group label: Omega3
arm group type: Experimental
description: The omega 3 group will receive 3g per day of fish oil during 90 days treatment
intervention type: Drug
intervention name: Omega 3
description: Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.
arm group label: Omega3
other name: fish oil
other name: omega 3 fatty acid
intervention type: Drug
intervention name: Placebo
description: mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule
arm group label: Placebo
other name: mineral oil
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: José Carlos F. Galduróz, Md PhD
role: Principal Investigator
affiliation: Universidade Federal de São Paulo (UNIFESP)
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Jose Carlos Fernandes Galduroz MD
investigator title: Md PhD
mesh term: Tobacco Use Disorder
mesh term: Mineral Oil
sharing ipd: No
ipd description: We do not plan to make individual participant data available. The data obtained was analysed and published
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 