<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/NCT01681875</url>
  </required_header>
  <id_info>
    <org_study_id>U54DA031659</org_study_id>
    <secondary_id>U54DA031659-01</secondary_id>
    <nct_id>NCT01681875</nct_id>
  </id_info>
  <brief_title>Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes</brief_title>
  <acronym>P1S1</acronym>
  <official_title>Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine&#xD;
      content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction,&#xD;
      other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure,&#xD;
      intention to quit, compensatory smoking, other tobacco use, cigarette characteristics,&#xD;
      cognitive function, cardiovascular function, and perceived risk. We will also consider&#xD;
      differences between conditions in compliance with product use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cigarettes smoked per day</measure>
    <time_frame>End of 6 week intervention</time_frame>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">839</enrollment>
  <condition>Tobacco Dependence</condition>
  <arm_group>
    <arm_group_label>0.8 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.26 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.12 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.07 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.03 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.04 mg nicotine with 13 mg tar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual brand</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>very low nicotine content cigarettes&#xD;
Usual brand cigarettes (control condition)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>very low nicotine content cigarettes</intervention_name>
    <arm_group_label>0.03 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_label>0.04 mg nicotine with 13 mg tar</arm_group_label>
    <arm_group_label>0.07 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_label>0.12 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_label>0.26 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_label>0.8 mg nicotine with 9 mg tar</arm_group_label>
    <arm_group_label>Usual brand</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18+&#xD;
&#xD;
          -  Smoke an average of at least five cigarettes per day for at least 1 year&#xD;
&#xD;
          -  Breath CO levels &gt; 8 ppm (if ≤ 8 ppm, then NicAlert Strip &gt; 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intention to quit smoking in the next 30 days&#xD;
&#xD;
          -  Currently seeking treatment for smoking cessation&#xD;
&#xD;
          -  Currently using nicotine replacement therapies or other pharmacotherapies as cessation&#xD;
             aid (intermittent use acceptable)&#xD;
&#xD;
          -  A quit attempt in the past 30 days resulting in greater than 3 days of abstinence&#xD;
&#xD;
          -  Using other tobacco products more than 9 days in the past 30 days&#xD;
&#xD;
          -  Significant unstable medical conditions (Any significant change in a serious medical&#xD;
             condition occurring during the past 3 months including, cardiovascular disease, COPD,&#xD;
             and cancer, as determined by the licensed medical professional at each site)&#xD;
&#xD;
          -  Significant unstable psychiatric conditions (Any significant change in psychiatric&#xD;
             symptoms during the past 3 months as determined by the licensed medical professional&#xD;
             at each site)&#xD;
&#xD;
          -  Schizophrenia and schizoaffective disorder&#xD;
&#xD;
          -  Psychiatric medication changes in the past 3 months&#xD;
&#xD;
          -  Positive toxicology screen for any of the following drugs: cocaine, opiates,&#xD;
             methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP&#xD;
&#xD;
               1. Marijuana will be tested for but will not be an exclusionary criterion.&#xD;
&#xD;
               2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates,&#xD;
                  amphetamines or methadone will not be excluded.&#xD;
&#xD;
               3. Participants failing the toxicology screen will be allowed to re-screen once.&#xD;
&#xD;
          -  Blood alcohol level &gt; 0.01&#xD;
&#xD;
             a. Participants failing the blood alcohol screen will be allowed to re-screen once.&#xD;
&#xD;
          -  Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour&#xD;
             period(female/male))&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Smoking 'roll your own cigarettes' exclusively&#xD;
&#xD;
          -  Currently taking anticonvulsant medication&#xD;
&#xD;
          -  CO reading &gt;80 ppm&#xD;
&#xD;
          -  Systolic BP greater than or equal to 160&#xD;
&#xD;
             a. Participants failing for blood pressure will be allowed to re-screen once.&#xD;
&#xD;
          -  Diastolic BP greater than or equal to 100&#xD;
&#xD;
             a. Participants failing for blood pressure will be allowed to re-screen once.&#xD;
&#xD;
          -  Systolic BP below 90&#xD;
&#xD;
             a. Participants failing for blood pressure will be allowed to re-screen once.&#xD;
&#xD;
          -  Diastolic BP below 50&#xD;
&#xD;
             a. Participants failing for blood pressure will be allowed to re-screen once.&#xD;
&#xD;
          -  Heart rate greater than or equal to 115bpm&#xD;
&#xD;
             a. Participants failing for heart rate will be allowed to re-screen once.&#xD;
&#xD;
          -  Heart rate lower than 45bpm&#xD;
&#xD;
             a. Participants failing for heart rate will be allowed to re-screen once.&#xD;
&#xD;
          -  Indicating any suicidal ideation in the past month or suicide attempts in the past 10&#xD;
             years&#xD;
&#xD;
          -  Inability to independently read and comprehend the consent form and other written&#xD;
             study materials and measures&#xD;
&#xD;
          -  Having participated in a research study during the past three months in which the&#xD;
             participant:&#xD;
&#xD;
               1. Smoked a cigarette that was not his/her usual brand cigarette for more than one&#xD;
                  day&#xD;
&#xD;
               2. Used any tobacco products beyond normal use for more than one day&#xD;
&#xD;
               3. Used any nicotine replacement products or smoking cessation medications for more&#xD;
                  than one day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric C Donny, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical School Duluth</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug Alcohol Depend. 2009 Sep 1;104(1-2):23-33. doi: 10.1016/j.drugalcdep.2009.01.021. Epub 2009 May 15.</citation>
    <PMID>19446968</PMID>
  </reference>
  <reference>
    <citation>Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.</citation>
    <PMID>20078491</PMID>
  </reference>
  <reference>
    <citation>Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.</citation>
    <PMID>22354905</PMID>
  </reference>
  <reference>
    <citation>Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction. 2007 Feb;102(2):324-34. doi: 10.1111/j.1360-0443.2006.01670.x.</citation>
    <PMID>17222288</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>August 13, 2018</last_update_submitted>
  <last_update_submitted_qc>August 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biomarkers of exposure</keyword>
  <keyword>Compensatory smoking</keyword>
  <keyword>Nicotine dependence</keyword>
  <keyword>Reduced nicotine cigarettes</keyword>
  <keyword>Tobacco withdrawal</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>
  <!-- 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/NCT01681875
org study id: U54DA031659
secondary id: U54DA031659-01
nct id: NCT01681875
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine
      content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction,
      other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure,
      intention to quit, compensatory smoking, other tobacco use, cigarette characteristics,
      cognitive function, cardiovascular function, and perceived risk. We will also consider
      differences between conditions in compliance with product use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of cigarettes smoked per day
time frame: End of 6 week intervention
arm group label: 0.8 mg nicotine with 9 mg tar
arm group type: Experimental
description: very low nicotine content cigarettes
SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)
arm group label: 0.26 mg nicotine with 9 mg tar
arm group type: Experimental
description: very low nicotine content cigarettes
SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar
arm group label: 0.12 mg nicotine with 9 mg tar
arm group type: Experimental
description: very low nicotine content cigarettes
SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar
arm group label: 0.07 mg nicotine with 9 mg tar
arm group type: Experimental
description: very low nicotine content cigarettes
SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar
arm group label: 0.03 mg nicotine with 9 mg tar
arm group type: Experimental
description: very low nicotine content cigarettes
SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar
arm group label: 0.04 mg nicotine with 13 mg tar
arm group type: Experimental
description: very low nicotine content cigarettes
SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar
arm group label: Usual brand
arm group type: Other
description: very low nicotine content cigarettes
Usual brand cigarettes (control condition)
intervention type: Other
intervention name: very low nicotine content cigarettes
arm group label: 0.03 mg nicotine with 9 mg tar
arm group label: 0.04 mg nicotine with 13 mg tar
arm group label: 0.07 mg nicotine with 9 mg tar
arm group label: 0.12 mg nicotine with 9 mg tar
arm group label: 0.26 mg nicotine with 9 mg tar
arm group label: 0.8 mg nicotine with 9 mg tar
arm group label: Usual brand
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric C Donny, PhD
role: Study Director
affiliation: University of Pittsburgh
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug Alcohol Depend. 2009 Sep 1;104(1-2):23-33. doi: 10.1016/j.drugalcdep.2009.01.021. Epub 2009 May 15.
PMID: 19446968
citation: Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.
PMID: 20078491
citation: Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.
PMID: 22354905
citation: Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction. 2007 Feb;102(2):324-34. doi: 10.1111/j.1360-0443.2006.01670.x.
PMID: 17222288
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Nicotine