xml: <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/NCT05994703</url>
    </required_header>
    <id_info>
      <org_study_id>CYCLE</org_study_id>
      <nct_id>NCT05994703</nct_id>
    </id_info>
    <brief_title>Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine</brief_title>
    <official_title>Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rose Research Center, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Foundation for a Smoke Free World INC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rose Research Center, LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        This study will evaluate the effects of a reward devaluation strategy, which has been&#xD;
        researched in the past, combined/augmented with the medication d-cycloserine in assisting&#xD;
        smokers to switch from combustible cigarette (CC) to Juul.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Smoking Abstinence based on Self-Report</measure>
      <time_frame>During weeks 3-6 and 9-12 post-switching date.</time_frame>
      <description>Complete switching from combustible cigarette use at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Smoking Abstinence based on Expired Air Carbon Monoxide (CO)</measure>
      <time_frame>End of Week 6, End of Week 12</time_frame>
      <description>Complete switching from combustible cigarette use at each time point will be confirmed by an expired air CO reading of less than 5 ppm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reduction in Cigarettes Per Day</measure>
      <time_frame>Week 6, Week 12, Six-Month Follow-Up</time_frame>
      <description>Reduction in the number of reports cigarettes smoked per day over the previous seven days (at each time point) compared to baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction in Expired Air Carbon Monoxide (CO)</measure>
      <time_frame>End of Week 6, End of Week 12</time_frame>
      <description>Reduction in Expired Air Carbon Monoxide (CO) compared to baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in rewarding effects for cigarettes and e-cigarettes at 6 weeks post switch</measure>
      <time_frame>End of Week 6</time_frame>
      <description>o assess subjective satisfaction and other perceived rewarding or aversive effects accompanying e-cigarette use and combustible cigarette use using the modified (e-Cigarette) Cigarette Evaluation Questionnaire. This questionnaire contains five subscale scores: smoking satisfaction (satisfying, tastes good, enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from &quot;1-not at all&quot; to &quot;7-extremely&quot;.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Tolerability of daily use of D-cycloserine in conjunction with Juul</measure>
      <time_frame>Week 2, Week 6, Week 8, Week 12</time_frame>
      <description>The frequency and severity of adverse events will be tabulated as well as the likelihood of their causal relationship to treatment.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Smoking Cessation</condition>
    <condition>Harm Reduction</condition>
    <arm_group>
      <arm_group_label>DCS with Juul e-cigarette</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks. There will be a 50 mg dose taken the afternoon/evening prior to the first switch date (after enrollment) to ensure serum levels of the medication are available for the first switch to e-cigarette attempt.&#xD;
  Participants will be instructed to use the Juul as often as they like during the 12 week period, and to switch completely to the Juul within 1 week. If, however, they do smoke any combustible cigarettes (CC), they will also be instructed to use the Juul immediately before each CC to relieve their craving as much as possible before smoking their usual brand. The Juul will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute Juul for CCs by the end of the first week of use.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>d-cycloserine</intervention_name>
      <description>d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks.</description>
      <arm_group_label>DCS with Juul e-cigarette</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Juul e-cigarette</intervention_name>
      <description>Juul use as often as the participant likes for 12 weeks.</description>
      <arm_group_label>DCS with Juul e-cigarette</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Has signed the informed consent form (ICF) and is able to understand the information&#xD;
               provided in the ICF.&#xD;
  &#xD;
            2. Is 22 to 65 years of age (inclusive) at screening.&#xD;
  &#xD;
            3. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last&#xD;
               12 months.&#xD;
  &#xD;
            4. Expired air CO reading of at least 10 ppm as assessed at the screening session.&#xD;
  &#xD;
            5. Interested in switching to an electronic cigarette.&#xD;
  &#xD;
            6. Willing and able to comply with the requirements of the study.&#xD;
  &#xD;
            7. Owns a smart phone with text message and data capabilities compatible with necessary&#xD;
               surveys.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Is unhealthy or cannot participate in the study for any reason (e.g., medical,&#xD;
               psychiatric, and/or social reason) as judged by the Investigator or designated medical&#xD;
               staff based on all available assessments from the screening period (e.g., safety&#xD;
               laboratory, vital signs, physical examination, ECG, concomitant medications and&#xD;
               medical history).&#xD;
  &#xD;
            2. Patient Health Questionnaire (PHQ-9) score greater than 9, or a score greater than 0&#xD;
               on item #9 (&quot;Thoughts that you would be better off dead, or of hurting yourself in&#xD;
               some way&quot;) at screening.&#xD;
  &#xD;
            3. Planned use of an FDA-approved smoking cessation product during the study.&#xD;
  &#xD;
            4. High Blood Pressure (systolic &gt;150 mm Hg, diastolic &gt;95 mm Hg) at screening.&#xD;
  &#xD;
            5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.&#xD;
  &#xD;
            6. Coronary heart disease, structural cardiac disease (including, but not limited to&#xD;
               valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac&#xD;
               chest pain, or history of heart attack or heart failure.&#xD;
  &#xD;
            7. Has received psychotherapy or behavioral treatments within 30 days of screening, or&#xD;
               during the study.&#xD;
  &#xD;
            8. Taking antidepressants or psychoactive medications (e.g., antipsychotics,&#xD;
               antidepressants, benzodiazepines, hypnotics).&#xD;
  &#xD;
            9. Use of any of these products in the past 30 days:&#xD;
  &#xD;
                 1. Illegal drugs (or if the urine drug screen is positive for cocaine,&#xD;
                    tetrahydrocannabinol (THC), amphetamines, methamphetamines, or opiates);&#xD;
  &#xD;
                 2. Experimental (investigational) drugs that are unknown to participant;&#xD;
  &#xD;
                 3. Chronic opiate use;&#xD;
  &#xD;
                 4. Medications to treat tuberculosis (e.g., isoniazid, ethionamide).&#xD;
  &#xD;
           10. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for &quot;Black &amp; Mild&quot;&#xD;
               cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or&#xD;
               other smoking cessation treatments within 14 days of screening.&#xD;
  &#xD;
           11. Pregnant or nursing (by self-report) or positive pregnancy test.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Rose Research Center</name>
        <address>
          <city>Charlotte</city>
          <state>North Carolina</state>
          <zip>28262</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Rose Research Center</name>
        <address>
          <city>Raleigh</city>
          <state>North Carolina</state>
          <zip>27617</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cycloserine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994703
  org study id: CYCLE
  nct id: NCT05994703
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study will evaluate the effects of a reward devaluation strategy, which has been
        researched in the past, combined/augmented with the medication d-cycloserine in assisting
        smokers to switch from combustible cigarette (CC) to Juul.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Smoking Abstinence based on Self-Report
  time frame: During weeks 3-6 and 9-12 post-switching date.
  description: Complete switching from combustible cigarette use at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session.
  measure: Smoking Abstinence based on Expired Air Carbon Monoxide (CO)
  time frame: End of Week 6, End of Week 12
  description: Complete switching from combustible cigarette use at each time point will be confirmed by an expired air CO reading of less than 5 ppm.
  measure: Reduction in Cigarettes Per Day
  time frame: Week 6, Week 12, Six-Month Follow-Up
  description: Reduction in the number of reports cigarettes smoked per day over the previous seven days (at each time point) compared to baseline.
  measure: Reduction in Expired Air Carbon Monoxide (CO)
  time frame: End of Week 6, End of Week 12
  description: Reduction in Expired Air Carbon Monoxide (CO) compared to baseline.
  measure: Change in rewarding effects for cigarettes and e-cigarettes at 6 weeks post switch
  time frame: End of Week 6
  description: o assess subjective satisfaction and other perceived rewarding or aversive effects accompanying e-cigarette use and combustible cigarette use using the modified (e-Cigarette) Cigarette Evaluation Questionnaire. This questionnaire contains five subscale scores: smoking satisfaction (satisfying, tastes good, enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from "1-not at all" to "7-extremely".
  measure: Tolerability of daily use of D-cycloserine in conjunction with Juul
  time frame: Week 2, Week 6, Week 8, Week 12
  description: The frequency and severity of adverse events will be tabulated as well as the likelihood of their causal relationship to treatment.
  arm group label: DCS with Juul e-cigarette
  arm group type: Experimental
  description: d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks. There will be a 50 mg dose taken the afternoon/evening prior to the first switch date (after enrollment) to ensure serum levels of the medication are available for the first switch to e-cigarette attempt.
  Participants will be instructed to use the Juul as often as they like during the 12 week period, and to switch completely to the Juul within 1 week. If, however, they do smoke any combustible cigarettes (CC), they will also be instructed to use the Juul immediately before each CC to relieve their craving as much as possible before smoking their usual brand. The Juul will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute Juul for CCs by the end of the first week of use.
  intervention type: Drug
  intervention name: d-cycloserine
  description: d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks.
  arm group label: DCS with Juul e-cigarette
  intervention type: Other
  intervention name: Juul e-cigarette
  description: Juul use as often as the participant likes for 12 weeks.
  arm group label: DCS with Juul e-cigarette
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Cycloserine
  sharing ipd: No