<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/NCT03766971</url>
  </required_header>
  <id_info>
    <org_study_id>7707</org_study_id>
    <nct_id>NCT03766971</nct_id>
  </id_info>
  <brief_title>Influence of Tobacco Use on Cannabis Use</brief_title>
  <official_title>Influence of Tobacco Use on Cannabis Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</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>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis&#xD;
      relapse relative to those who do not use tobacco. There is a clear need to develop and&#xD;
      evaluate interventions for dual tobacco and cannabis users. The investigators of this study&#xD;
      have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of&#xD;
      daily cannabis use, and that age of cigarette onset is a critical predictor of treatment&#xD;
      outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in&#xD;
      later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for&#xD;
      earlier-onset smokers. In the current study, a human laboratory model will be utilized to&#xD;
      determine whether cannabis relapse varies as a function of tobacco cessation duration and age&#xD;
      of tobacco use onset.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on&#xD;
    NYSPI research that included a pause of human research as of June 23, 2023.&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (&lt;16 years) and the other half later (&gt;=16 years).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Research staff will be blind to the age of tobacco onset condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cannabis self-administration</measure>
    <time_frame>During 9-day inpatient phase</time_frame>
    <description>Number of cannabis cigarettes participant chooses to smoke.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Cannabis Use</condition>
  <condition>Tobacco Use</condition>
  <arm_group>
    <arm_group_label>Early-onset Cigarette Smokers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who began smoking cigarettes earlier in life (&lt;16 years old) will be randomized to 7 or 21 days of tobacco cessation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late-onset Cigarette Smokers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who began smoking cigarettes later in life (&gt;16 years old) will be randomized to 7 or 21 days of tobacco cessation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>7 days of Tobacco Cessation</intervention_name>
    <description>Participants will be randomly assigned to 7 days of tobacco cessation.</description>
    <arm_group_label>Early-onset Cigarette Smokers</arm_group_label>
    <arm_group_label>Late-onset Cigarette Smokers</arm_group_label>
    <other_name>Early onset</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>21 days of Tobacco Cessation</intervention_name>
    <description>Participants will be randomly assigned to 21 days of tobacco cessation.</description>
    <arm_group_label>Early-onset Cigarette Smokers</arm_group_label>
    <arm_group_label>Late-onset Cigarette Smokers</arm_group_label>
    <other_name>Late onset</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabis</intervention_name>
    <description>Participants will receive cannabis.</description>
    <arm_group_label>Early-onset Cigarette Smokers</arm_group_label>
    <arm_group_label>Late-onset Cigarette Smokers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and non-pregnant females aged 18-60 years old&#xD;
&#xD;
          -  Use cannabis&#xD;
&#xD;
          -  Smoke tobacco cigarettes&#xD;
&#xD;
          -  Medically and psychologically healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular drug use other than cannabis&#xD;
&#xD;
          -  Current pregnancy/lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</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>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Margaret Haney</investigator_full_name>
    <investigator_title>Professor of Psychiatry, Columbia University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03766971
org study id: 7707
nct id: NCT03766971
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis
      relapse relative to those who do not use tobacco. There is a clear need to develop and
      evaluate interventions for dual tobacco and cannabis users. The investigators of this study
      have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of
      daily cannabis use, and that age of cigarette onset is a critical predictor of treatment
      outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in
      later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for
      earlier-onset smokers. In the current study, a human laboratory model will be utilized to
      determine whether cannabis relapse varies as a function of tobacco cessation duration and age
      of tobacco use onset.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (<16 years) and the other half later (>=16 years).
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Research staff will be blind to the age of tobacco onset condition.
measure: Cannabis self-administration
time frame: During 9-day inpatient phase
description: Number of cannabis cigarettes participant chooses to smoke.
arm group label: Early-onset Cigarette Smokers
arm group type: Experimental
description: Participants who began smoking cigarettes earlier in life (<16 years old) will be randomized to 7 or 21 days of tobacco cessation.
arm group label: Late-onset Cigarette Smokers
arm group type: Experimental
description: Participants who began smoking cigarettes later in life (>16 years old) will be randomized to 7 or 21 days of tobacco cessation.
intervention type: Behavioral
intervention name: 7 days of Tobacco Cessation
description: Participants will be randomly assigned to 7 days of tobacco cessation.
arm group label: Early-onset Cigarette Smokers
arm group label: Late-onset Cigarette Smokers
other name: Early onset
intervention type: Behavioral
intervention name: 21 days of Tobacco Cessation
description: Participants will be randomly assigned to 21 days of tobacco cessation.
arm group label: Early-onset Cigarette Smokers
arm group label: Late-onset Cigarette Smokers
other name: Late onset
intervention type: Drug
intervention name: Cannabis
description: Participants will receive cannabis.
arm group label: Early-onset Cigarette Smokers
arm group label: Late-onset Cigarette Smokers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Margaret Haney
investigator title: Professor of Psychiatry, Columbia University
mesh term: Marijuana Abuse
sharing ipd: Undecided