<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/NCT03840694</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00101055</org_study_id>
    <nct_id>NCT03840694</nct_id>
  </id_info>
  <brief_title>Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior</brief_title>
  <acronym>NicWith</acronym>
  <official_title>Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Food and Drug Administration (FDA)</agency>
      <agency_class>U.S. Fed</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to find out how smoking affects the way the brain responds to pleasure&#xD;
      and how this impacts smokers' behavior. Participants will complete three sessions. The first&#xD;
      session will be a screening and training visit to determine final eligibility. Eligible&#xD;
      participants will work with a researcher to develop brief scripts about times when they smoke&#xD;
      and do other activities. Next, participants will attend two magnetic resonance imaging (MRI)&#xD;
      scans - one after abstaining from smoking for 24 hours and the other after smoking as usual.&#xD;
      After the second MRI, participants will answer questions on their phone every day for two&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI leaving for another institution.&#xD;
  </why_stopped>
  <start_date type="Actual">September 10, 2019</start_date>
  <completion_date type="Actual">May 13, 2021</completion_date>
  <primary_completion_date type="Actual">May 13, 2021</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>
    <intervention_model_description>Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Oxygen Level Dependent (BOLD) Activation</measure>
    <time_frame>Approximately 1-3 weeks</time_frame>
    <description>BOLD activation in brain reward network regions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ecological Momentary Assessment (EMA) Pleasure Ratings</measure>
    <time_frame>2-6 weeks</time_frame>
    <description>Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Cigarette Smoking</condition>
  <condition>Nicotine Withdrawal</condition>
  <arm_group>
    <arm_group_label>Smoking Abstinence</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ad Lib Smoking</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will continue smoking as usual (i.e. &quot;ad lib&quot;) before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Smoking Abstinence</intervention_name>
    <description>Participants will abstain from smoking for 24 hours.</description>
    <arm_group_label>Smoking Abstinence</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ad Lib Smoking</intervention_name>
    <description>Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.</description>
    <arm_group_label>Ad Lib Smoking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally healthy&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Smoke &gt;= 10 cigarettes per day&#xD;
&#xD;
          -  Smoking regularly for &gt;= 1 year&#xD;
&#xD;
          -  Carbon Monoxide (CO) &gt; 8 at screening (or urinary cotinine &gt; 100)&#xD;
&#xD;
          -  Own a compatible smartphone&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
          -  Able to identify at least 4 pleasurable activities they do not do concurrently with&#xD;
             smoking or associate with smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular use of &quot;roll your own&quot; cigarettes&#xD;
&#xD;
          -  Planning to quit smoking within the next 60 days&#xD;
&#xD;
          -  Current or planned smoking cessation treatment&#xD;
&#xD;
          -  Regular use of smokeless tobacco or other nicotine products&#xD;
&#xD;
          -  Expired CO &gt; 80 parts per million&#xD;
&#xD;
          -  Breath alcohol &gt; .000 at screening (re-attempts are allowed)&#xD;
&#xD;
          -  Positive toxicology screen for exclusionary drugs&#xD;
&#xD;
          -  Use of exclusionary medications&#xD;
&#xD;
          -  Significant medical problems&#xD;
&#xD;
          -  Currently breastfeeding, pregnant, or planning to become pregnant&#xD;
&#xD;
          -  Enrollment in another study utilizing Spectrum cigarettes within the last 3 months&#xD;
&#xD;
          -  Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason A Oliver, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University School of Medicine</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>May 2021</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with the Office of Research Contracts to obtain guidance regarding any required Data Use Agreements as needed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>We anticipate making data available within 6 months of study completion. It will be available for an indefinite period of time.</ipd_time_frame>
    <ipd_access_criteria>Contact PI for details.</ipd_access_criteria>
  </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/NCT03840694
org study id: Pro00101055
nct id: NCT03840694
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to find out how smoking affects the way the brain responds to pleasure
      and how this impacts smokers' behavior. Participants will complete three sessions. The first
      session will be a screening and training visit to determine final eligibility. Eligible
      participants will work with a researcher to develop brief scripts about times when they smoke
      and do other activities. Next, participants will attend two magnetic resonance imaging (MRI)
      scans - one after abstaining from smoking for 24 hours and the other after smoking as usual.
      After the second MRI, participants will answer questions on their phone every day for two
      weeks.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Blood Oxygen Level Dependent (BOLD) Activation
time frame: Approximately 1-3 weeks
description: BOLD activation in brain reward network regions
measure: Ecological Momentary Assessment (EMA) Pleasure Ratings
time frame: 2-6 weeks
description: Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.
arm group label: Smoking Abstinence
arm group type: Other
description: Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing
arm group label: Ad Lib Smoking
arm group type: Other
description: Participants will continue smoking as usual (i.e. "ad lib") before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing.
intervention type: Other
intervention name: Smoking Abstinence
description: Participants will abstain from smoking for 24 hours.
arm group label: Smoking Abstinence
intervention type: Other
intervention name: Ad Lib Smoking
description: Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.
arm group label: Ad Lib Smoking
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason A Oliver, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance Withdrawal Syndrome
sharing ipd: Yes
ipd description: Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with the Office of Research Contracts to obtain guidance regarding any required Data Use Agreements as needed.
ipd info type: Study Protocol
ipd time frame: We anticipate making data available within 6 months of study completion. It will be available for an indefinite period of time.
ipd access criteria: Contact PI for details.