<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/NCT03302026</url>
  </required_header>
  <id_info>
    <org_study_id>828012</org_study_id>
    <nct_id>NCT03302026</nct_id>
  </id_info>
  <brief_title>Real Time fMRI and Quitting Smoking</brief_title>
  <official_title>A Proof-of-concept Study of Real-time fMRI Neurofeedback Training for Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine how real-time functional magnetic resonance imaging (rt-fMRI)&#xD;
      feedback can be used to modulate brain activation in the context of smoking cues in order to&#xD;
      resist craving. Participants will complete a total of three fMRI scanning sessions with a cue&#xD;
      suppression task with or without neurofeedback training (NFT). Participants will be&#xD;
      randomized to an active group (active NFT) or a control group (no NFT) during the scanning&#xD;
      sessions. At the end of the third session, all participants will complete a validated smoking&#xD;
      lapse laboratory paradigm to evaluate effects of NFT on smoking behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking is the greatest preventable cause of mortality and a significant economic burden.&#xD;
      Even with the best available treatments, most smokers relapse within days or weeks after a&#xD;
      quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end&#xD;
      of treatment quit rates of &lt;25% suggesting that managing nicotine withdrawal is not&#xD;
      sufficient. A smoker's response to smoking cues is one factor that increases risk of relapse.&#xD;
      This study will examine how real-time functional magnetic resonance imaging (rt-fMRI)&#xD;
      feedback can be used to modulate brain activation in the context of smoking cues in order to&#xD;
      resist craving. First, we will conduct a pilot study in 12 smokers for technical development&#xD;
      and to evaluate the feasibility of the proposed study procedures. Participants will complete&#xD;
      a total of three fMRI scanning sessions with a cue suppression task with or without&#xD;
      neurofeedback training (NFT). Participants will be randomized to an active group (active NFT)&#xD;
      or a control group (no NFT) during the scanning sessions. At the end of the third session,&#xD;
      all participants will complete a validated smoking lapse laboratory paradigm to evaluate&#xD;
      effects of NFT on smoking behavior. Upon successful completion of the technical development&#xD;
      phase, we will proceed to a proof-of-concept phase, which will recruit 72 smokers to evaluate&#xD;
      the efficacy of NFT for smoking behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>
    <intervention_model_description>The proposed study will evaluate the effects of rt-fMRI neurofeedback training on the ability to resist craving for cigarettes. The study will be conducted in two phases: a technical development phase and a proof-of-concept phase focused on efficacy. The technical development phase will be completed before beginning the proof-of-concept phase. Eligible consenting treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group. Both groups will complete three scanning sessions, followed by a smoking resist evaluation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking Lapse Paradigm</measure>
    <time_frame>Study session 3 (scan day 3)</time_frame>
    <description>Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cue induced brain signal change</measure>
    <time_frame>Study session 3 (scan day 3)</time_frame>
    <description>Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Nicotine Use Disorder</condition>
  <arm_group>
    <arm_group_label>Real-time neurofeedback training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In this arm, participants will complete four sessions: an intake session and 3 neurofeedback scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-feedback control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In the control group arm, participants will complete four sessions: an intake session and 3 scanning visits with no neurofeeback. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Realtime biofeedback using fMRI</intervention_name>
    <description>Real-time fMRI (rt-fMRI) allows for rapid analysis of brain activation while an individual is actively performing a task, and can be used to provide real-time neurofeedback to individuals during fMRI scanning. Using neurofeedback, individuals can learn to modulate activity in specific regions of the brain. We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. Participants will complete four sessions: an intake session and 3 scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm.</description>
    <arm_group_label>Real-time neurofeedback training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at&#xD;
             least 10 cigarettes per day for at least the past 6 months;&#xD;
&#xD;
          2. Planning to live in the area for at least the next month;&#xD;
&#xD;
          3. Capable of giving written informed consent, which includes compliance with the&#xD;
             requirements and restrictions listed in the combined consent and HIPAA form;&#xD;
&#xD;
          4. Able to communicate fluently in English (speaking, writing, and reading).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Smoking Behavior:&#xD;
&#xD;
          1. Use of chewing tobacco or snuff or cigars;&#xD;
&#xD;
          2. Current enrollment or plans to enroll in another smoking cessation program or research&#xD;
             study in the next month;&#xD;
&#xD;
          3. Current or anticipated (within the next month) use of smoking cessation medications or&#xD;
             nicotine replacement therapy (NRT);&#xD;
&#xD;
          4. A baseline carbon monoxide (CO) reading less than 10ppm.&#xD;
&#xD;
        Alcohol/Drugs:&#xD;
&#xD;
          1. Current alcohol consumption that exceeds 25 standard drinks/week;&#xD;
&#xD;
          2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at&#xD;
             intake; a. Participants testing positive for breath alcohol with a reading equal to or&#xD;
             greater than .08 (the legal driving limit) or who are visibly impaired will be&#xD;
             instructed not to drive themselves home after the appointment. If a participant needs&#xD;
             to use a phone to call for a safe ride home, an office telephone will be made&#xD;
             available to the participant.&#xD;
&#xD;
        Medication:&#xD;
&#xD;
        Current use or recent discontinuation (within the past 30 days at the time of Intake) of:&#xD;
&#xD;
          1. Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);&#xD;
&#xD;
          2. Anti-psychotic medications;&#xD;
&#xD;
          3. Any medication that could compromise participant safety as determined by the Principal&#xD;
             Investigator and/or Study Physician;&#xD;
&#xD;
             Daily use of:&#xD;
&#xD;
          4. Opiate-containing medications for chronic pain.&#xD;
&#xD;
        Medical/Neuropsychiatric:&#xD;
&#xD;
          1. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female&#xD;
             subjects of childbearing potential will undergo a urine pregnancy test at Intake and&#xD;
             at each scan session.&#xD;
&#xD;
          2. History of epilepsy or a seizure disorder;&#xD;
&#xD;
          3. History of stroke;&#xD;
&#xD;
          4. Self-reported brain (or CNS) or spinal tumor;&#xD;
&#xD;
          5. Self-reported history of head trauma;&#xD;
&#xD;
          6. Self-reported history or current diagnosis of psychosis.&#xD;
&#xD;
        fMRI-Related:&#xD;
&#xD;
          1. Self-reported use of pacemakers, certain metallic implants, or presence of metal in&#xD;
             the eye as contraindicated for fMRI;&#xD;
&#xD;
          2. Self-reported history of claustrophobia;&#xD;
&#xD;
          3. Being left-handed;&#xD;
&#xD;
          4. Color blindness;&#xD;
&#xD;
          5. Weight greater than 250lbs at intake;&#xD;
&#xD;
          6. Self-reported history of gunshot wounds;&#xD;
&#xD;
          7. Any impairment preventing participants from using the response pad necessary for the&#xD;
             computer tasks;&#xD;
&#xD;
          8. Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).&#xD;
&#xD;
        General Exclusion:&#xD;
&#xD;
          1. Any medical condition, illness, disorder, or concomitant medication that could&#xD;
             compromise participant safety or treatment, as determined by the Principal&#xD;
             Investigator;&#xD;
&#xD;
          2. Enrollment or plans to enroll in another research study;&#xD;
&#xD;
          3. Inability to provide informed consent or complete any of the study tasks as determined&#xD;
             by the Principal Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nicotine treatment</keyword>
  <keyword>real time fMRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</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/NCT03302026
org study id: 828012
nct id: NCT03302026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine how real-time functional magnetic resonance imaging (rt-fMRI)
      feedback can be used to modulate brain activation in the context of smoking cues in order to
      resist craving. Participants will complete a total of three fMRI scanning sessions with a cue
      suppression task with or without neurofeedback training (NFT). Participants will be
      randomized to an active group (active NFT) or a control group (no NFT) during the scanning
      sessions. At the end of the third session, all participants will complete a validated smoking
      lapse laboratory paradigm to evaluate effects of NFT on smoking behavior.
Smoking is the greatest preventable cause of mortality and a significant economic burden.
      Even with the best available treatments, most smokers relapse within days or weeks after a
      quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end
      of treatment quit rates of <25% suggesting that managing nicotine withdrawal is not
      sufficient. A smoker's response to smoking cues is one factor that increases risk of relapse.
      This study will examine how real-time functional magnetic resonance imaging (rt-fMRI)
      feedback can be used to modulate brain activation in the context of smoking cues in order to
      resist craving. First, we will conduct a pilot study in 12 smokers for technical development
      and to evaluate the feasibility of the proposed study procedures. Participants will complete
      a total of three fMRI scanning sessions with a cue suppression task with or without
      neurofeedback training (NFT). Participants will be randomized to an active group (active NFT)
      or a control group (no NFT) during the scanning sessions. At the end of the third session,
      all participants will complete a validated smoking lapse laboratory paradigm to evaluate
      effects of NFT on smoking behavior. Upon successful completion of the technical development
      phase, we will proceed to a proof-of-concept phase, which will recruit 72 smokers to evaluate
      the efficacy of NFT for smoking behavior.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The proposed study will evaluate the effects of rt-fMRI neurofeedback training on the ability to resist craving for cigarettes. The study will be conducted in two phases: a technical development phase and a proof-of-concept phase focused on efficacy. The technical development phase will be completed before beginning the proof-of-concept phase. Eligible consenting treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group. Both groups will complete three scanning sessions, followed by a smoking resist evaluation.
primary purpose: Treatment
masking: Single (Participant)
masking description: Treatment-seeking smokers complete an intake session and then be randomized to an active NFT group or a control group.
measure: Smoking Lapse Paradigm
time frame: Study session 3 (scan day 3)
description: Time (sec) to first cigarette during a 50 minute monitored smoking lapse period in smoking laboratory
measure: Cue induced brain signal change
time frame: Study session 3 (scan day 3)
description: Change in mean percent signal change for Cue minus Neutral contrasts in activated brain regions
arm group label: Real-time neurofeedback training group
arm group type: Experimental
description: We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In this arm, participants will complete four sessions: an intake session and 3 neurofeedback scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.
arm group label: No-feedback control group
arm group type: No Intervention
description: We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. In the control group arm, participants will complete four sessions: an intake session and 3 scanning visits with no neurofeeback. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm. Secondary outcomes include changes in brain activity in areas related to craving and self-control, and self-reported craving for cigarettes.
intervention type: Behavioral
intervention name: Realtime biofeedback using fMRI
description: Real-time fMRI (rt-fMRI) allows for rapid analysis of brain activation while an individual is actively performing a task, and can be used to provide real-time neurofeedback to individuals during fMRI scanning. Using neurofeedback, individuals can learn to modulate activity in specific regions of the brain. We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. Participants will complete four sessions: an intake session and 3 scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm.
arm group label: Real-time neurofeedback training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
sharing ipd: Undecided