<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/NCT01684995</url>
  </required_header>
  <id_info>
    <org_study_id>Quit_RIte_RI</org_study_id>
    <secondary_id>R01DA010860</secondary_id>
    <nct_id>NCT01684995</nct_id>
  </id_info>
  <brief_title>Motivation and Nicotine Patch Treatment for Under-served Smokers</brief_title>
  <official_title>Motivation and Nicotine Patch Treatment for Under-served Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</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>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to test, in combination with the nicotine patch, the incremental&#xD;
      efficacy of a motivationally tailored behavioral intervention over a minimal intervention.&#xD;
      The interventions will be delivered through primary care medical clinics. The defined&#xD;
      population comprises low income, less educated smokers who will vary in their level of&#xD;
      motivation to quit smoking. Patients will be randomly assigned within clinics to one of two&#xD;
      interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and&#xD;
      (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored&#xD;
      motivational intervention, a behavioral skills counseling session for smoking cessation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 1996</start_date>
  <completion_date type="Actual">November 1999</completion_date>
  <primary_completion_date type="Actual">November 1999</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <number_of_arms>2</number_of_arms>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Minimal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief physician advice to quit smoking plus nicotine patch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tailored</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief physician advice</intervention_name>
    <description>Brief physician advice to quit smoking</description>
    <arm_group_label>Minimal</arm_group_label>
    <arm_group_label>Tailored</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nicotine patch</intervention_name>
    <description>nicotine patch</description>
    <arm_group_label>Minimal</arm_group_label>
    <arm_group_label>Tailored</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individually Tailored Behavioral Skills training</intervention_name>
    <description>Individually tailored behavioral skills training for smoking cessation</description>
    <arm_group_label>Tailored</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Currently smoking at least 10 cigarettes/day for past 3 months&#xD;
&#xD;
          -  Speak English or Spanish&#xD;
&#xD;
          -  Have a telephone or live close to a relative or neighbor with a telephone&#xD;
&#xD;
          -  Agree to participate in the study and be available over the next 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to use nicotine patch due to medical status&#xD;
&#xD;
          -  Active skin condition or history of skin allergy&#xD;
&#xD;
          -  Currently using smokeless tobacco, nicotine replacement or other smoking cessation&#xD;
             treatment&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 13, 2012</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>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/NCT01684995
org study id: Quit_RIte_RI
secondary id: R01DA010860
nct id: NCT01684995
lead sponsor: 
collaborator: 
has dmc: No
The goal of this study is to test, in combination with the nicotine patch, the incremental
      efficacy of a motivationally tailored behavioral intervention over a minimal intervention.
      The interventions will be delivered through primary care medical clinics. The defined
      population comprises low income, less educated smokers who will vary in their level of
      motivation to quit smoking. Patients will be randomly assigned within clinics to one of two
      interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and
      (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored
      motivational intervention, a behavioral skills counseling session for smoking cessation.
intervention model: Parallel Assignment
primary purpose: Treatment
arm group label: Minimal
arm group type: Active Comparator
description: Brief physician advice to quit smoking plus nicotine patch
arm group label: Tailored
arm group type: Experimental
intervention type: Behavioral
intervention name: Brief physician advice
description: Brief physician advice to quit smoking
arm group label: Minimal
arm group label: Tailored
intervention type: Drug
intervention name: nicotine patch
description: nicotine patch
arm group label: Minimal
arm group label: Tailored
intervention type: Behavioral
intervention name: Individually Tailored Behavioral Skills training
description: Individually tailored behavioral skills training for smoking cessation
arm group label: Tailored
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine