<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/NCT02989038</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00075882</org_study_id>
    <secondary_id>R01DA042532</secondary_id>
    <nct_id>NCT02989038</nct_id>
  </id_info>
  <brief_title>Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers</brief_title>
  <acronym>NicRed</acronym>
  <official_title>Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke 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>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate reactions to, and choices to self-administer,&#xD;
      cigarette smoke with varying nicotine content among low-frequency, non-dependent&#xD;
      adolescent/young adult smokers between the ages of 15-25 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will undergo three sessions in which their reactions to fixed doses of smoke&#xD;
      from investigational cigarettes with three different nicotine contents (15.8 mg/gram of&#xD;
      tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session,&#xD;
      participants will return to the lab to choose one of the cigarettes to self-administer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 22, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective reactions to fixed doses of tobacco smoke</measure>
    <time_frame>Immediately after puff administration of each study cigarette</time_frame>
    <description>Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cigarette choice</measure>
    <time_frame>30 minutes after sampling all 3 study cigarettes</time_frame>
    <description>Participants will choose which of the three cigarettes they prefer to smoke by ranking each of the three cigarette conditions using a 1-3 scale where 1 is the cigarette that they most desire to smoke and 3 is the cigarette that they least desire to smoke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood and Affect</measure>
    <time_frame>Immediately after puff administration of each study cigarette</time_frame>
    <description>The Positive and Negative Affect Schedule (PANAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood and Affect</measure>
    <time_frame>Immediately after puff administration of each study cigarette</time_frame>
    <description>Minnesota Nicotine Withdrawal Scale (MNWS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration</measure>
    <time_frame>Immediately after puff administration of each study cigarette</time_frame>
    <description>CO values (in ppm) will be obtained using a handheld CO monitor prior to puff administration and 5 minutes after completion of cigarette puff administration. The difference in values will provide a CO boost value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking topography - number of puffs</measure>
    <time_frame>During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)</time_frame>
    <description>number of puffs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking topography - interpuff interval</measure>
    <time_frame>During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)</time_frame>
    <description>Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">182</enrollment>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>NNC, INC, VLNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NNC, VLNC, INC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INC, VLNC, NNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INC, NNC, VLNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VLNC, NNC, INC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VLNC, INC, NNC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Very Low Nicotine Content Cigarettes</intervention_name>
    <description>cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield</description>
    <arm_group_label>INC, NNC, VLNC</arm_group_label>
    <arm_group_label>INC, VLNC, NNC</arm_group_label>
    <arm_group_label>NNC, INC, VLNC</arm_group_label>
    <arm_group_label>NNC, VLNC, INC</arm_group_label>
    <arm_group_label>VLNC, INC, NNC</arm_group_label>
    <arm_group_label>VLNC, NNC, INC</arm_group_label>
    <other_name>Tobacco</other_name>
    <other_name>Cigarettes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermediate Nicotine Content Cigarettes</intervention_name>
    <description>cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield</description>
    <arm_group_label>INC, NNC, VLNC</arm_group_label>
    <arm_group_label>INC, VLNC, NNC</arm_group_label>
    <arm_group_label>NNC, INC, VLNC</arm_group_label>
    <arm_group_label>NNC, VLNC, INC</arm_group_label>
    <arm_group_label>VLNC, INC, NNC</arm_group_label>
    <arm_group_label>VLNC, NNC, INC</arm_group_label>
    <other_name>Tobacco</other_name>
    <other_name>Cigarettes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Nicotine Content Cigarettes</intervention_name>
    <description>cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield</description>
    <arm_group_label>INC, NNC, VLNC</arm_group_label>
    <arm_group_label>INC, VLNC, NNC</arm_group_label>
    <arm_group_label>NNC, INC, VLNC</arm_group_label>
    <arm_group_label>NNC, VLNC, INC</arm_group_label>
    <arm_group_label>VLNC, INC, NNC</arm_group_label>
    <arm_group_label>VLNC, NNC, INC</arm_group_label>
    <other_name>Tobacco</other_name>
    <other_name>Cigarettes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  generally healthy&#xD;
&#xD;
          -  between the ages of 15-25&#xD;
&#xD;
          -  use nicotine or tobacco products between 1-15 days/month for at least 6 months&#xD;
&#xD;
          -  smokes at least 5 cigarettes/month&#xD;
&#xD;
          -  no unstable or significant medical or psychiatric conditions&#xD;
&#xD;
          -  breath alcohol value=0.000&#xD;
&#xD;
          -  able to provide contact information for two individuals who can corroborate smoking&#xD;
             status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of illegal drugs as measured by urine drug screen (excluding THC)&#xD;
&#xD;
          -  serious quit attempt in the past 3 months&#xD;
&#xD;
          -  plans to quit smoking in the next 2 months&#xD;
&#xD;
          -  current use of nicotine replacement therapy or other tobacco cessation products&#xD;
&#xD;
          -  inability to attend all required experimental sessions&#xD;
&#xD;
          -  blood pressure &gt;160/100 mmHg&#xD;
&#xD;
          -  pregnant, trying to become pregnant, or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francis J McClernon, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoker</keyword>
  <keyword>young adult</keyword>
  <keyword>adolescent</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>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989038
org study id: Pro00075882
secondary id: R01DA042532
nct id: NCT02989038
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate reactions to, and choices to self-administer,
      cigarette smoke with varying nicotine content among low-frequency, non-dependent
      adolescent/young adult smokers between the ages of 15-25 years.
Participants will undergo three sessions in which their reactions to fixed doses of smoke
      from investigational cigarettes with three different nicotine contents (15.8 mg/gram of
      tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session,
      participants will return to the lab to choose one of the cigarettes to self-administer.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Subjective reactions to fixed doses of tobacco smoke
time frame: Immediately after puff administration of each study cigarette
description: Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes
measure: Cigarette choice
time frame: 30 minutes after sampling all 3 study cigarettes
description: Participants will choose which of the three cigarettes they prefer to smoke by ranking each of the three cigarette conditions using a 1-3 scale where 1 is the cigarette that they most desire to smoke and 3 is the cigarette that they least desire to smoke.
measure: Mood and Affect
time frame: Immediately after puff administration of each study cigarette
description: The Positive and Negative Affect Schedule (PANAS)
measure: Mood and Affect
time frame: Immediately after puff administration of each study cigarette
description: Minnesota Nicotine Withdrawal Scale (MNWS)
measure: Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration
time frame: Immediately after puff administration of each study cigarette
description: CO values (in ppm) will be obtained using a handheld CO monitor prior to puff administration and 5 minutes after completion of cigarette puff administration. The difference in values will provide a CO boost value
measure: Smoking topography - number of puffs
time frame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
description: number of puffs
measure: Smoking topography - interpuff interval
time frame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
description: Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette
arm group label: NNC, INC, VLNC
arm group type: Experimental
description: Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)
arm group label: NNC, VLNC, INC
arm group type: Experimental
description: Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content
arm group label: INC, VLNC, NNC
arm group type: Experimental
description: Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content
arm group label: INC, NNC, VLNC
arm group type: Experimental
description: Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content
arm group label: VLNC, NNC, INC
arm group type: Experimental
description: Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content
arm group label: VLNC, INC, NNC
arm group type: Experimental
description: Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content
intervention type: Other
intervention name: Very Low Nicotine Content Cigarettes
description: cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
arm group label: INC, NNC, VLNC
arm group label: INC, VLNC, NNC
arm group label: NNC, INC, VLNC
arm group label: NNC, VLNC, INC
arm group label: VLNC, INC, NNC
arm group label: VLNC, NNC, INC
other name: Tobacco
other name: Cigarettes
intervention type: Other
intervention name: Intermediate Nicotine Content Cigarettes
description: cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
arm group label: INC, NNC, VLNC
arm group label: INC, VLNC, NNC
arm group label: NNC, INC, VLNC
arm group label: NNC, VLNC, INC
arm group label: VLNC, INC, NNC
arm group label: VLNC, NNC, INC
other name: Tobacco
other name: Cigarettes
intervention type: Other
intervention name: Normal Nicotine Content Cigarettes
description: cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
arm group label: INC, NNC, VLNC
arm group label: INC, VLNC, NNC
arm group label: NNC, INC, VLNC
arm group label: NNC, VLNC, INC
arm group label: VLNC, INC, NNC
arm group label: VLNC, NNC, INC
other name: Tobacco
other name: Cigarettes
criteria: 
gender: All
minimum age: 15 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Francis J McClernon, Ph.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Nicotine
sharing ipd: No