<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/NCT03015597</url>
  </required_header>
  <id_info>
    <org_study_id>171709</org_study_id>
    <nct_id>NCT03015597</nct_id>
  </id_info>
  <brief_title>Pilot Study of Contingency Management for Smoking Cessation</brief_title>
  <official_title>Addition of Contingency Management to Stop Smoking Services for Patients Undergoing Treatment for Opiate Addiction: a Randomised Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see whether contingency management (CM) can be successfully&#xD;
      added as an adjunct treatment to standard stop smoking services in outpatients undergoing&#xD;
      treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for&#xD;
      opiate addiction will be stratified to a CM intervention for either smoking abstinence or&#xD;
      attendance at the clinic, whilst also receiving usual stop smoking services cessation&#xD;
      treatment. The intervention will run for five weeks and participants will be followed up six&#xD;
      months after the beginning of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to investigate whether a contingency management (CM) intervention can be added&#xD;
      to usual NHS stop smoking services (SSS) treatment, in patients undergoing treatment for&#xD;
      opiate addiction.&#xD;
&#xD;
      The SSS at the treatment centre follows the standard treatment program set out by the&#xD;
      National Centre for Smoking Cessation and Training (NCSCT) and the NICE guidelines for&#xD;
      smoking cessation. Service users taking part in the SSS attend one meeting per week for six&#xD;
      weeks. In the first meeting with a cessation worker the client completes baseline information&#xD;
      about the client's age, gender, ethnicity, employment, motivation to quit, past quit attempts&#xD;
      and current smoking behaviour), and sets a quit date for the following week. For the&#xD;
      remaining four weeks clients attend the clinic to receive behavioural support. Nicotine&#xD;
      replacement therapy (NRT) is available free of charge to all individuals engaged with SSS.&#xD;
      During the six weeks of treatment, service users are given a week's supply of NRT at a time.&#xD;
      At the end of the six weeks, service users are given a two week supply of NRT before exiting&#xD;
      the SSS treatment. NRT use is recorded throughout SSS treatment. Clients' breath carbon&#xD;
      monoxide (CO) levels are also measured at the initial visit and at each subsequent visit over&#xD;
      the next 5 weeks in order to biochemically verify self-reported abstinence from smoking&#xD;
      (CO&lt;10ppm).&#xD;
&#xD;
      The CM intervention that this study will run as an adjunct to the SSS,. The 40 participants&#xD;
      will be randomised into either experimental (CM for abstinence) or control (CM for&#xD;
      attendance) conditions at intake. Randomisation will be stratified based on participants'&#xD;
      current smoking frequency (between 10 and 20 per day, and more than 20 per day). The&#xD;
      intervention will run for five weeks in total, with randomisation occurring at visit 1, and&#xD;
      the intervention beginning in week two of the SSS treatment and ending in week six.&#xD;
      Participants will be rewarded for smoking abstinence in the experimental condition, and for&#xD;
      attending the SSS clinic in the control condition. For the experimental condition smoking&#xD;
      abstinence will be defined as a breath CO reading of &lt;10ppm, and for the control condition&#xD;
      attendance will be defined as attending the SSS clinic once a week. Rewards will be&#xD;
      administered by a researcher to ensure cessation workers are not aware of group allocation.&#xD;
&#xD;
      The intervention will employ an 'escalating with reset' schedule, Reward values will be the&#xD;
      same in both conditions. In escalating with reset CM, rewards escalate in a set increment&#xD;
      value for each successive verified display of the desired behaviour. When the desired&#xD;
      behaviour is not observed, no reward is given, and the reward value for the next verified&#xD;
      display of the desired behaviour is reset to that of the initial reward. Reward values then&#xD;
      begin to rise again in the same way as before.&#xD;
&#xD;
      Six months after their set quit date, participants will be contacted by the PI to ascertain&#xD;
      their self-reported smoking status. In order to test the optimal follow up method,&#xD;
      participants will be pseudo-randomised to be contacted by text and phone call, or email and&#xD;
      phone call. All participants will also be asked to return to the clinic in order to have&#xD;
      their breath CO levels tested to verify this. Once this is done, participants will have&#xD;
      completed their participation in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Number of participants completing treatment in each condition</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of participants completing treatment in each condition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of negative samples</measure>
    <time_frame>Each week throughout intervention (weeks 1-6) and at 6 month follow up</time_frame>
    <description>Percentage of biochemically verified (exhaled air carbon monoxide) negative breath samples b) Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longest duration of abstinence</measure>
    <time_frame>Each week throughout intervention (weeks 1-6) and at 6 month follow up</time_frame>
    <description>Number of consecutively biochemically verified (exhaled air carbon monoxide) negative breath samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Point Prevalence abstinence</measure>
    <time_frame>Each week throughout intervention (weeks 1-6) and at 6 month follow up</time_frame>
    <description>Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Smoking</condition>
  <condition>Tobacco Smoking</condition>
  <condition>Smoking, Tobacco</condition>
  <condition>Smoking Cessation</condition>
  <condition>Opiate Addiction</condition>
  <condition>Opiate Dependence</condition>
  <arm_group>
    <arm_group_label>Contingency Management: smoking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contingency Management: smoking&#xD;
Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contingency Management: attendance</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Contingency Management: attendance&#xD;
Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Contingency Management</intervention_name>
    <description>Contingency management is a behavioural intervention based on the principals of operant conditioning that is widely used in the addictions field. At the most basic level, contingency management works by providing rewards as reinforcement for desired behaviours. In the current study, the desired behaviours are either attendance at the clinic and abstinence from tobacco smoking, or just attendance at the clinic, dependent on the arm of the trial that participants are randomised to. Participants in the experimental condition will receive shopping vouchers for attending the clinic and providing a breath CO recording of &lt;10ppm. Participants in the control condition will receive shopping vouchers for attending the clinic, regardless of their breath CO recording results.</description>
    <arm_group_label>Contingency Management: attendance</arm_group_label>
    <arm_group_label>Contingency Management: smoking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Want to quit smoking&#xD;
&#xD;
          -  Between 18 and 65 years old&#xD;
&#xD;
          -  Undergoing current pharmacological treatment for opiate addiction&#xD;
&#xD;
          -  Smoke a minimum of 10 cigarettes per day&#xD;
&#xD;
          -  Provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient English skills to understand study protocols&#xD;
&#xD;
          -  Currently undergoing treatment for drugs other that opiates or tobacco&#xD;
&#xD;
          -  Taking part in other research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann McNeill, PhD</last_name>
    <role>Study Director</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lorraine Hewitt Hosue</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>November 27, 2017</last_update_submitted>
  <last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Tobacco Smoking</keyword>
  <keyword>Smoking, Tobacco</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Opiate Addiction</keyword>
  <keyword>Opiate Dependence</keyword>
  <keyword>Contingency Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Permission is not being sought for this from participants to expedite recruitment</ipd_description>
  </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/NCT03015597
org study id: 171709
nct id: NCT03015597
lead sponsor: 
has dmc: No
The purpose of this study is to see whether contingency management (CM) can be successfully
      added as an adjunct treatment to standard stop smoking services in outpatients undergoing
      treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for
      opiate addiction will be stratified to a CM intervention for either smoking abstinence or
      attendance at the clinic, whilst also receiving usual stop smoking services cessation
      treatment. The intervention will run for five weeks and participants will be followed up six
      months after the beginning of the study.
The study aims to investigate whether a contingency management (CM) intervention can be added
      to usual NHS stop smoking services (SSS) treatment, in patients undergoing treatment for
      opiate addiction.

      The SSS at the treatment centre follows the standard treatment program set out by the
      National Centre for Smoking Cessation and Training (NCSCT) and the NICE guidelines for
      smoking cessation. Service users taking part in the SSS attend one meeting per week for six
      weeks. In the first meeting with a cessation worker the client completes baseline information
      about the client's age, gender, ethnicity, employment, motivation to quit, past quit attempts
      and current smoking behaviour), and sets a quit date for the following week. For the
      remaining four weeks clients attend the clinic to receive behavioural support. Nicotine
      replacement therapy (NRT) is available free of charge to all individuals engaged with SSS.
      During the six weeks of treatment, service users are given a week's supply of NRT at a time.
      At the end of the six weeks, service users are given a two week supply of NRT before exiting
      the SSS treatment. NRT use is recorded throughout SSS treatment. Clients' breath carbon
      monoxide (CO) levels are also measured at the initial visit and at each subsequent visit over
      the next 5 weeks in order to biochemically verify self-reported abstinence from smoking
      (CO<10ppm).

      The CM intervention that this study will run as an adjunct to the SSS,. The 40 participants
      will be randomised into either experimental (CM for abstinence) or control (CM for
      attendance) conditions at intake. Randomisation will be stratified based on participants'
      current smoking frequency (between 10 and 20 per day, and more than 20 per day). The
      intervention will run for five weeks in total, with randomisation occurring at visit 1, and
      the intervention beginning in week two of the SSS treatment and ending in week six.
      Participants will be rewarded for smoking abstinence in the experimental condition, and for
      attending the SSS clinic in the control condition. For the experimental condition smoking
      abstinence will be defined as a breath CO reading of <10ppm, and for the control condition
      attendance will be defined as attending the SSS clinic once a week. Rewards will be
      administered by a researcher to ensure cessation workers are not aware of group allocation.

      The intervention will employ an 'escalating with reset' schedule, Reward values will be the
      same in both conditions. In escalating with reset CM, rewards escalate in a set increment
      value for each successive verified display of the desired behaviour. When the desired
      behaviour is not observed, no reward is given, and the reward value for the next verified
      display of the desired behaviour is reset to that of the initial reward. Reward values then
      begin to rise again in the same way as before.

      Six months after their set quit date, participants will be contacted by the PI to ascertain
      their self-reported smoking status. In order to test the optimal follow up method,
      participants will be pseudo-randomised to be contacted by text and phone call, or email and
      phone call. All participants will also be asked to return to the clinic in order to have
      their breath CO levels tested to verify this. Once this is done, participants will have
      completed their participation in the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants completing treatment in each condition
time frame: 6 weeks
description: Number of participants completing treatment in each condition
measure: Percentage of negative samples
time frame: Each week throughout intervention (weeks 1-6) and at 6 month follow up
description: Percentage of biochemically verified (exhaled air carbon monoxide) negative breath samples b) Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence
measure: Longest duration of abstinence
time frame: Each week throughout intervention (weeks 1-6) and at 6 month follow up
description: Number of consecutively biochemically verified (exhaled air carbon monoxide) negative breath samples
measure: Point Prevalence abstinence
time frame: Each week throughout intervention (weeks 1-6) and at 6 month follow up
description: Biochemically verified (exhaled air carbon monoxide) point prevalence smoking abstinence
arm group label: Contingency Management: smoking
arm group type: Experimental
description: Contingency Management: smoking
Participants receive rewards contingent on biochemical verification of tobacco smoking abstinence
arm group label: Contingency Management: attendance
arm group type: Placebo Comparator
description: Contingency Management: attendance
Participants receive rewards contingent on attending the stop smoking clinic (independent of smoking status)
intervention type: Behavioral
intervention name: Contingency Management
description: Contingency management is a behavioural intervention based on the principals of operant conditioning that is widely used in the addictions field. At the most basic level, contingency management works by providing rewards as reinforcement for desired behaviours. In the current study, the desired behaviours are either attendance at the clinic and abstinence from tobacco smoking, or just attendance at the clinic, dependent on the arm of the trial that participants are randomised to. Participants in the experimental condition will receive shopping vouchers for attending the clinic and providing a breath CO recording of <10ppm. Participants in the control condition will receive shopping vouchers for attending the clinic, regardless of their breath CO recording results.
arm group label: Contingency Management: attendance
arm group label: Contingency Management: smoking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ann McNeill, PhD
role: Study Director
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Behavior, Addictive
sharing ipd: No
ipd description: Permission is not being sought for this from participants to expedite recruitment