<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/NCT02218944</url>
  </required_header>
  <id_info>
    <org_study_id>SM14171</org_study_id>
    <nct_id>NCT02218944</nct_id>
  </id_info>
  <brief_title>Smoking Response Inhibition Training</brief_title>
  <official_title>Response Inhibition Training in Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Dakota State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>North Dakota State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study tests a response inhibition retraining program, implemented on a mobile&#xD;
      device, as a mechanism to increase relapse prevention during a smoking cessation attempt.&#xD;
      Study participants (n = 150) are randomly assigned to a control, benign, or intervention&#xD;
      condition. They complete 2 weeks of response inhibition retraining, and then engage in a&#xD;
      cessation attempt. It is hypothesized that individuals who receive the intervention will have&#xD;
      a decreased likelihood of relapse following the cessation attempt. In addition, it is&#xD;
      hypothesized that this is due to decreases in implicit smoking motivation as a function of&#xD;
      the response inhibition training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking is the leading preventable cause of death and disease in the U.S. Each year&#xD;
      approximately 30% of smokers try to quit, with the vast majority of attempts (~90%) ending in&#xD;
      relapse. This is complicated by treatment barriers related to cost and accessibility.&#xD;
      Identifying cost effective ways to aide in cessation success, which can be widely&#xD;
      disseminated, remains vitally important. According to the dual-process model of substance&#xD;
      use, addiction develops via an imbalance between effortful control and automatic&#xD;
      psychological processes. The affective processing model suggests that during withdrawal,&#xD;
      automatic psychological processes increase implicit drug seeking motivation. Implicit&#xD;
      motivation is hypothesized as the underlying mechanism through which automatic psychological&#xD;
      processes exert control over behavior. Research suggests that behavioral impulse control may&#xD;
      attenuate the association between implicit motivation and substance use. Response inhibition,&#xD;
      one form of behavioral impulse control, is the ability to inhibit behavioral responses to&#xD;
      salient approach cues. Smokers tend to have less behavioral impulse control. In addition,&#xD;
      poor behavioral impulse control makes individuals more vulnerable to various risk factors&#xD;
      associated with relapse (e.g., positive expectancies, higher craving during abstinence,&#xD;
      etc.). Improving smoking relevant behavioral impulse control may affect multiple indices of&#xD;
      relapse. Research in cognitive retraining has shown that response inhibition can be modified&#xD;
      through training. Recently this has been extended to training using mobile devices. The&#xD;
      development of mobile interventions which specifically target underlying mechanisms of&#xD;
      addiction may provide a novel adjunct to current cessation programs. The current proposal&#xD;
      builds on previous research by implementing a response inhibition training paradigm in the&#xD;
      context of a cessation trial. It is hypothesized that this task will reduce the likelihood of&#xD;
      relapse following a quit attempt. Furthermore, it is hypothesized that training effects will&#xD;
      operate via decreases in implicit motivation and global craving. If successful, the current&#xD;
      study will provide evidence for a relapse prevention tool that can (1) increase overall&#xD;
      cessation success and (2) be widely and easily dispersed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking relapse</measure>
    <time_frame>6 months</time_frame>
    <description>A relapse is defined as a resumption of smoking behavior, following a cessation attempt, with the acknowledgement that the study participant is no longer trying to quit smoking. Abstinence is verified with Cotinine.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Response Inhibition Training: A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental condition, 20% of responses are no-go, with the majority of no-go responses paired with smoking images.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Response Inhibition Training: B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the active comparator condition, 20% of responses are no-go trials, with no-go responses spread evenly across the various images.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benign</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A benign condition has also been added to control for the possibility that response inhibition training, regardless of target, increases behavioral control and hence decreases relapse likelihood. The benign condition has 50% no-go trials, with no-go responses spread evenly across images.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Response Inhibition Training</intervention_name>
    <description>The primary purpose of this research is to examine the feasibility and efficacy of a smoking specific response inhibition training program in the context of a quit attempt. The task is based on a modified stop-signal task. The study utilizes a one-way nested design with three conditions.</description>
    <arm_group_label>Response Inhibition Training: A</arm_group_label>
    <arm_group_label>Response Inhibition Training: B</arm_group_label>
    <other_name>Stop-signal Task; Go/No-Go Task</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals 18-45 years old, who smoke at least 10 cigarettes/day, score 5 or higher&#xD;
             on the Fägerstrom Test of Nicotine Dependence, express a desire to quit, and have no&#xD;
             current psychiatric diagnoses.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals will be ineligible to participate if they have used other tobacco products&#xD;
             (e.g., smokeless tobacco) on more than 5 days in the past month, intend to quit&#xD;
             smoking using pharmacotherapy, or are non-English speaking.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert D Dvorak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amy Scott, PhD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Dakota State University</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02218944
org study id: SM14171
nct id: NCT02218944
lead sponsor: 
has dmc: No
The current study tests a response inhibition retraining program, implemented on a mobile
      device, as a mechanism to increase relapse prevention during a smoking cessation attempt.
      Study participants (n = 150) are randomly assigned to a control, benign, or intervention
      condition. They complete 2 weeks of response inhibition retraining, and then engage in a
      cessation attempt. It is hypothesized that individuals who receive the intervention will have
      a decreased likelihood of relapse following the cessation attempt. In addition, it is
      hypothesized that this is due to decreases in implicit smoking motivation as a function of
      the response inhibition training.
Smoking is the leading preventable cause of death and disease in the U.S. Each year
      approximately 30% of smokers try to quit, with the vast majority of attempts (~90%) ending in
      relapse. This is complicated by treatment barriers related to cost and accessibility.
      Identifying cost effective ways to aide in cessation success, which can be widely
      disseminated, remains vitally important. According to the dual-process model of substance
      use, addiction develops via an imbalance between effortful control and automatic
      psychological processes. The affective processing model suggests that during withdrawal,
      automatic psychological processes increase implicit drug seeking motivation. Implicit
      motivation is hypothesized as the underlying mechanism through which automatic psychological
      processes exert control over behavior. Research suggests that behavioral impulse control may
      attenuate the association between implicit motivation and substance use. Response inhibition,
      one form of behavioral impulse control, is the ability to inhibit behavioral responses to
      salient approach cues. Smokers tend to have less behavioral impulse control. In addition,
      poor behavioral impulse control makes individuals more vulnerable to various risk factors
      associated with relapse (e.g., positive expectancies, higher craving during abstinence,
      etc.). Improving smoking relevant behavioral impulse control may affect multiple indices of
      relapse. Research in cognitive retraining has shown that response inhibition can be modified
      through training. Recently this has been extended to training using mobile devices. The
      development of mobile interventions which specifically target underlying mechanisms of
      addiction may provide a novel adjunct to current cessation programs. The current proposal
      builds on previous research by implementing a response inhibition training paradigm in the
      context of a cessation trial. It is hypothesized that this task will reduce the likelihood of
      relapse following a quit attempt. Furthermore, it is hypothesized that training effects will
      operate via decreases in implicit motivation and global craving. If successful, the current
      study will provide evidence for a relapse prevention tool that can (1) increase overall
      cessation success and (2) be widely and easily dispersed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Smoking relapse
time frame: 6 months
description: A relapse is defined as a resumption of smoking behavior, following a cessation attempt, with the acknowledgement that the study participant is no longer trying to quit smoking. Abstinence is verified with Cotinine.
arm group label: Response Inhibition Training: A
arm group type: Experimental
description: In the experimental condition, 20% of responses are no-go, with the majority of no-go responses paired with smoking images.
arm group label: Response Inhibition Training: B
arm group type: Active Comparator
description: In the active comparator condition, 20% of responses are no-go trials, with no-go responses spread evenly across the various images.
arm group label: Benign
arm group type: Placebo Comparator
description: A benign condition has also been added to control for the possibility that response inhibition training, regardless of target, increases behavioral control and hence decreases relapse likelihood. The benign condition has 50% no-go trials, with no-go responses spread evenly across images.
intervention type: Behavioral
intervention name: Response Inhibition Training
description: The primary purpose of this research is to examine the feasibility and efficacy of a smoking specific response inhibition training program in the context of a quit attempt. The task is based on a modified stop-signal task. The study utilizes a one-way nested design with three conditions.
arm group label: Response Inhibition Training: A
arm group label: Response Inhibition Training: B
other name: Stop-signal Task; Go/No-Go Task
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert D Dvorak, PhD
role: Principal Investigator
affiliation: Amy Scott, PhD
facility: 
country: United States
responsible party type: Sponsor