<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/NCT02195570</url>
  </required_header>
  <id_info>
    <org_study_id>20130654</org_study_id>
    <secondary_id>R34DA031973</secondary_id>
    <nct_id>NCT02195570</nct_id>
  </id_info>
  <brief_title>Contingency Management for Smoking Cessation in Pregnant Minority Women</brief_title>
  <official_title>Contingency Management for Smoking Cessation in Pregnant Minority Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</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>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long-term goal of this research is to reduce tobacco-related disparities in maternal and&#xD;
      infant health outcomes by improving smoking cessation and relapse prevention interventions&#xD;
      for minority pregnant and postpartum women, who have been significantly underrepresented in&#xD;
      smoking cessation research. This study will examine the feasibility and efficacy of a&#xD;
      prize-based contingency management approach for increasing smoking cessation and preventing&#xD;
      relapse among socioeconomically disadvantaged minority pregnant smokers. First, the&#xD;
      intervention will be pretested with 10 pregnant low-income minority smokers and then refined&#xD;
      based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60&#xD;
      highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a&#xD;
      large teaching hospital, who report daily smoking and who meet other eligibility criteria&#xD;
      will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational&#xD;
      Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now&#xD;
      curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational&#xD;
      Intervention plus Contingency Management (provision of incentives contingent on&#xD;
      biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide&#xD;
      and salivary cotinine levels will occur in both groups beginning on the first quit day and&#xD;
      continuing through 3-months postpartum. Only participants in the QSN-CM group will be&#xD;
      reinforced for biochemically-verified abstinence with chances to win prizes ranging in value&#xD;
      from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be&#xD;
      assessed through follow-up research exams (delivery and 6-months postpartum) and hospital&#xD;
      chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition&#xD;
      will have higher rates of abstinence during pregnancy and postpartum compared to women&#xD;
      receiving standard of care alone. Results should advance scientific knowledge regarding&#xD;
      effective methods for promoting and maintaining smoking abstinence among pregnant&#xD;
      disadvantaged women and provide preliminary feasibility and efficacy data needed to support a&#xD;
      larger randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to identify and recruit eligible participants&#xD;
  </why_stopped>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abstinence Duration</measure>
    <time_frame>(from quit date through 6 months postpartum; assessed up to 52 weeks)</time_frame>
    <description>-duration in days&#xD;
--measured by self-report, carbon monoxide, salivary and urine cotinine levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abstinence rate (%)</measure>
    <time_frame>delivery and 6 months postpartum</time_frame>
    <description>7-day point prevalence abstinence at delivery and 6 months postpartum defined by no smoking in the 7 days prior to assessment.&#xD;
measured by self-report, carbon monoxide and salivary cotinine levels.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>QSN attendance</measure>
    <time_frame>(6 weeks)</time_frame>
    <description>cumulative attendance at QSN sessions (1-6 weeks)&#xD;
QSN attendance logs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking reduction</measure>
    <time_frame>Change (baseline and delivery; baseline and 6 months postpartum)</time_frame>
    <description>-change in the number of cigarettes smoked daily by self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational Age</measure>
    <time_frame>delivery</time_frame>
    <description>measured in weeks&#xD;
documented through medical chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Respiratory Illnesses</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>number of episodes&#xD;
documented through medical chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth Weight</measure>
    <time_frame>delivery</time_frame>
    <description>birth weight measured in grams&#xD;
documented through medical chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Admissions</measure>
    <time_frame>delivery</time_frame>
    <description>duration in days&#xD;
documented through medical chart review</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>QSN with CM (QSN-CM).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will receive standard of care Quit Smoking Now tobacco education and support plus prize-based contingency management. Their smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Women will earn chances to win prizes each time they test negative for smoking according to biochemical measures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QSN Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women receive the standard of care Quit Smoking Now tobacco education and support only. Smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Incentives are given for providing breath and salivary samples but are not contingent on smoking status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quit Smoking Now (QSN)</intervention_name>
    <description>The Quit Smoking Now (QSN) program, offered by the Florida Area Health Education Center, was developed based on principles of the Centers for Disease Control and Prevention's &quot;Best Practices for Comprehensive Tobacco Control&quot;, and the U.S. Department of Health and Human Services' &quot;Treating Tobacco Use and Dependence Clinical Guidelines&quot; with an emphasis on reaching medically-underserved populations. The QSN curriculum will be delivered in 6 one-hour sessions . Pregnancy-specific session goals and content cover the effects of smoking on the developing fetus, secondhand smoke exposure, the importance of social support, and postpartum relapse.</description>
    <arm_group_label>QSN Only</arm_group_label>
    <arm_group_label>QSN with CM (QSN-CM).</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prize-based Contingency Management (CM)</intervention_name>
    <description>Women will earn chances to win prizes for biochemically verified abstinence from tobacco.</description>
    <arm_group_label>QSN with CM (QSN-CM).</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-identified daily smoker (at least 1 cigarette/day)&#xD;
&#xD;
          -  &lt;28 weeks gestation&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  resident of Miami-Dade County, Florida&#xD;
&#xD;
          -  able to read and speak in English or Spanish&#xD;
&#xD;
          -  plans to continue prenatal care with Jackson Health System&#xD;
&#xD;
          -  plans to remain in the Miami-Dade County metropolitan area for at least 6 months&#xD;
             following delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participation in another smoking cessation intervention within the past year&#xD;
&#xD;
          -  use of nicotine replacement therapy (NRT) anytime during pregnancy&#xD;
&#xD;
          -  inability to give informed consent&#xD;
&#xD;
          -  incarceration&#xD;
&#xD;
          -  reported regular use of alcohol (&gt;3 times/week) or marijuana (&gt;weekly); any cocaine or&#xD;
             opiates in past year; or a positive toxicology for these drugs.&#xD;
&#xD;
        Study withdrawal will occur in the case of pregnancy termination, fetal demise or by&#xD;
        participant request.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronica H Accornero, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Veronica Accornero</investigator_full_name>
    <investigator_title>Associate Professor of Clinical Pediatrics</investigator_title>
  </responsible_party>
  <keyword>contingency management</keyword>
  <keyword>smoking cessation</keyword>
  <keyword>prenatal tobacco exposure</keyword>
  <keyword>maternal smoking</keyword>
  <!-- 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/NCT02195570
org study id: 20130654
secondary id: R34DA031973
nct id: NCT02195570
lead sponsor: 
collaborator: 
has dmc: Yes
The long-term goal of this research is to reduce tobacco-related disparities in maternal and
      infant health outcomes by improving smoking cessation and relapse prevention interventions
      for minority pregnant and postpartum women, who have been significantly underrepresented in
      smoking cessation research. This study will examine the feasibility and efficacy of a
      prize-based contingency management approach for increasing smoking cessation and preventing
      relapse among socioeconomically disadvantaged minority pregnant smokers. First, the
      intervention will be pretested with 10 pregnant low-income minority smokers and then refined
      based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60
      highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a
      large teaching hospital, who report daily smoking and who meet other eligibility criteria
      will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational
      Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now
      curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational
      Intervention plus Contingency Management (provision of incentives contingent on
      biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide
      and salivary cotinine levels will occur in both groups beginning on the first quit day and
      continuing through 3-months postpartum. Only participants in the QSN-CM group will be
      reinforced for biochemically-verified abstinence with chances to win prizes ranging in value
      from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be
      assessed through follow-up research exams (delivery and 6-months postpartum) and hospital
      chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition
      will have higher rates of abstinence during pregnancy and postpartum compared to women
      receiving standard of care alone. Results should advance scientific knowledge regarding
      effective methods for promoting and maintaining smoking abstinence among pregnant
      disadvantaged women and provide preliminary feasibility and efficacy data needed to support a
      larger randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Abstinence Duration
time frame: (from quit date through 6 months postpartum; assessed up to 52 weeks)
description: -duration in days
--measured by self-report, carbon monoxide, salivary and urine cotinine levels
measure: Abstinence rate (%)
time frame: delivery and 6 months postpartum
description: 7-day point prevalence abstinence at delivery and 6 months postpartum defined by no smoking in the 7 days prior to assessment.
measured by self-report, carbon monoxide and salivary cotinine levels.
measure: QSN attendance
time frame: (6 weeks)
description: cumulative attendance at QSN sessions (1-6 weeks)
QSN attendance logs
measure: Smoking reduction
time frame: Change (baseline and delivery; baseline and 6 months postpartum)
description: -change in the number of cigarettes smoked daily by self-report
measure: Gestational Age
time frame: delivery
description: measured in weeks
documented through medical chart review
measure: Infant Respiratory Illnesses
time frame: 6 months postpartum
description: number of episodes
documented through medical chart review
measure: Birth Weight
time frame: delivery
description: birth weight measured in grams
documented through medical chart review
measure: Neonatal Admissions
time frame: delivery
description: duration in days
documented through medical chart review
arm group label: QSN with CM (QSN-CM).
arm group type: Experimental
description: Women will receive standard of care Quit Smoking Now tobacco education and support plus prize-based contingency management. Their smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Women will earn chances to win prizes each time they test negative for smoking according to biochemical measures.
arm group label: QSN Only
arm group type: Active Comparator
description: Women receive the standard of care Quit Smoking Now tobacco education and support only. Smoking status will be monitored from quit date through 3 months postpartum via carbon monoxide and salivary cotinine levels. Incentives are given for providing breath and salivary samples but are not contingent on smoking status.
intervention type: Other
intervention name: Quit Smoking Now (QSN)
description: The Quit Smoking Now (QSN) program, offered by the Florida Area Health Education Center, was developed based on principles of the Centers for Disease Control and Prevention's "Best Practices for Comprehensive Tobacco Control", and the U.S. Department of Health and Human Services' "Treating Tobacco Use and Dependence Clinical Guidelines" with an emphasis on reaching medically-underserved populations. The QSN curriculum will be delivered in 6 one-hour sessions . Pregnancy-specific session goals and content cover the effects of smoking on the developing fetus, secondhand smoke exposure, the importance of social support, and postpartum relapse.
arm group label: QSN Only
arm group label: QSN with CM (QSN-CM).
intervention type: Behavioral
intervention name: Prize-based Contingency Management (CM)
description: Women will earn chances to win prizes for biochemically verified abstinence from tobacco.
arm group label: QSN with CM (QSN-CM).
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Veronica H Accornero, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Veronica Accornero
investigator title: Associate Professor of Clinical Pediatrics