<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/NCT04432064</url>
  </required_header>
  <id_info>
    <org_study_id>1904451651</org_study_id>
    <nct_id>NCT04432064</nct_id>
  </id_info>
  <brief_title>Temporal Interference Neurostimulation and Addiction</brief_title>
  <official_title>Temporal Interference Neurostimulation and Addiction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indiana University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to develop a line of research using new non-invasive neurostimulation&#xD;
      technology to treat adults with opioid use disorders (OUDs). In the short term, the&#xD;
      investigators aim to identify novel target brain regions for neurostimulation treatment and&#xD;
      characterize their effects behaviorally and neurally. In the longer term, investigators aim&#xD;
      to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial&#xD;
      direct current stimulation and non-invasive deep brain stimulation to these areas to&#xD;
      partially or completely disrupt addiction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesize that temporal interference non-invasive deep brain stimulation&#xD;
      (TI-NDBS) will be well tolerated and effective at manipulating brain activity and reducing&#xD;
      drug cravings. The investigators will investigate whether stimulation with a mild current&#xD;
      from temporal interference non-invasive deep brain stimulation (TI-NDBS) to the Anterior&#xD;
      Cingulate Cortex (ACC), the anterior insula (AI), or the nucleus accumbens (NAcc) will reduce&#xD;
      nicotine craving and seeking. The TI-NDBS is similar to the traditional transcranial direct&#xD;
      current stimulation (tDCS), a method approved for use in a number of other studies. Other&#xD;
      studies have shown there have been some effects of reducing craving with tDCS, however, tDCS&#xD;
      cannot stimulate structures such as the ACC very effectively because tDCS cannot stimulate&#xD;
      deeper brain regions. Thus, the Specific Aim ultimately will compare TI-NDBS with tDCS and&#xD;
      sham stimulation. The study is broken up into four phases. The first two will involve device&#xD;
      feasibility and identifying the best locations for the electrodes to be placed. In the third&#xD;
      phase, the investigators will compare TI-NDBS with sham stimulation. In the fourth phase, the&#xD;
      investigators will compare TI-NDBS with sham stimulation and with tDCS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">May 2027</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>One group of 20 participants will receive active TI-NDBS and another group of 20 participants will receive sham TI-NDBS. A third group of 20 participants will receive traditional transcranial direct current stimulation (tDCS).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>This will be single-blind masking as the experimenter will need to know which intervention to run on the participant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Nicotine craving</measure>
    <time_frame>Within the first year of testing TI-NDBS in nicotine smokers.</time_frame>
    <description>The investigators predict that TI-NDBS will outperform sham stimulation at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with TI-NDBS vs tDCS. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Nicotine craving due to TI-NDBS compared to tDCS</measure>
    <time_frame>1 year after the first primary outcome.</time_frame>
    <description>The investigators predict that TI-NDBS will outperform tDCS at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with one of the stimulation groups vs. sham. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Nicotine Use Disorder</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>Phase 3 Active TI-NDBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3 Sham TI-NDBS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 4 Traditional tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 4 TI-NDBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation for 60 minutes for 5 days and will be compared to sham stimulation and tDCS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 4 Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds. Participants will be in the scanner for 60 minutes for 5 days. This will be used as the control condition and compared with TI-NDBS and tDCS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active TI-NDBS</intervention_name>
    <description>In the active TI-NDBS condition, subjects will receive stimulation for 60 minutes applied to the brain through scalp electrodes. There will be a maximum of 2 mA per electrode pair and no single region will receive more than 2 mA because the currents will be administered to distinct regions. At the beginning of each stimulation period, the current will increase slowly at a constant rate for 30 seconds until it reaches the appropriate intensity. At the end of the stimulation, the current will decrease slowly for 30 seconds until it reaches zero.</description>
    <arm_group_label>Phase 3 Active TI-NDBS</arm_group_label>
    <arm_group_label>Phase 4 TI-NDBS</arm_group_label>
    <other_name>Temporal Interference Non-invasive Deep Brain Stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham TI-NDBS</intervention_name>
    <description>This is the control condition in which participants will receive sham stimulation for 60 minutes.</description>
    <arm_group_label>Phase 3 Sham TI-NDBS</arm_group_label>
    <arm_group_label>Phase 4 Sham stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>This is a well established method of brain stimulation and will be used to compare against the efficacy of TI-NDBS in the reduction of nicotine craving and inhalation. Participants will receive stimulation for 60 minutes.</description>
    <arm_group_label>Phase 4 Traditional tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be between the ages of 18 and 40, must have at least 6th grade education, and the&#xD;
             ability to speak and read English, must smoke at least 3/4 of a pack of cigarettes per&#xD;
             day, must have phone with internet access.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if they are on psychotropic medications for ADHD, other mental illness or medication&#xD;
             for cancer, epilepsy (i.e. individuals with any history of seizure disorder),&#xD;
             migraines, or other neurological syndromes, or AIDs (which can cause cognitive&#xD;
             deficits (Watkins &amp; Treisman, 2015), history of head trauma, history of cognitive&#xD;
             impairments, metal implants in the head or under the scalp, personal experiences&#xD;
             consistent with symptoms of psychosis (i.e. mind or body being secretly controlled,&#xD;
             special powers, seeing or hearing things that aren't really there).&#xD;
&#xD;
          -  Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e.&#xD;
             metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or if a&#xD;
             participant uses an IUD for birth control they will be excluded unless the subject can&#xD;
             document the model of the IUD and we can verify its safety for the MRI environment.&#xD;
             Pregnancy should be self-reported, and a pregnancy test will not be administered.&#xD;
             Participants must also weigh less than 440 lbs.&#xD;
&#xD;
          -  History of holes bored into skull or known fissures in cranial bones&#xD;
&#xD;
          -  Presence of pacemakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Joshua Brown, PhD</last_name>
    <phone>812-855-9282</phone>
    <email>jwmbrown@indiana.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua Brown, PhD</last_name>
      <phone>812-855-9282</phone>
      <email>jwmbrown@indiana.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.</citation>
    <PMID>18312035</PMID>
  </reference>
  <reference>
    <citation>Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.</citation>
    <PMID>28575667</PMID>
  </reference>
  <reference>
    <citation>Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.</citation>
    <PMID>24814566</PMID>
  </reference>
  <reference>
    <citation>Hulvershorn LA, Hummer TA, Fukunaga R, Leibenluft E, Finn P, Cyders MA, Anand A, Overhage L, Dir A, Brown J. Neural activation during risky decision-making in youth at high risk for substance use disorders. Psychiatry Res. 2015 Aug 30;233(2):102-11. doi: 10.1016/j.pscychresns.2015.05.007. Epub 2015 May 21.</citation>
    <PMID>26071624</PMID>
  </reference>
  <reference>
    <citation>Wing VC, Barr MS, Wass CE, Lipsman N, Lozano AM, Daskalakis ZJ, George TP. Brain stimulation methods to treat tobacco addiction. Brain Stimul. 2013 May;6(3):221-30. doi: 10.1016/j.brs.2012.06.008. Epub 2012 Jul 9.</citation>
    <PMID>22809824</PMID>
  </reference>
  <reference>
    <citation>Velez de Mendizabal N, Jones DR, Jahn A, Bies RR, Brown JW. Nicotine and cotinine exposure from electronic cigarettes: a population approach. Clin Pharmacokinet. 2015 Jun;54(6):615-26. doi: 10.1007/s40262-014-0221-7.</citation>
    <PMID>25503588</PMID>
  </reference>
  <reference>
    <citation>Naqvi NH, Rudrauf D, Damasio H, Bechara A. Damage to the insula disrupts addiction to cigarette smoking. Science. 2007 Jan 26;315(5811):531-4. doi: 10.1126/science.1135926.</citation>
    <PMID>17255515</PMID>
  </reference>
  <reference>
    <citation>Naqvi NH, Gaznick N, Tranel D, Bechara A. The insula: a critical neural substrate for craving and drug seeking under conflict and risk. Ann N Y Acad Sci. 2014 May;1316:53-70. doi: 10.1111/nyas.12415. Epub 2014 Apr 1.</citation>
    <PMID>24690001</PMID>
  </reference>
  <reference>
    <citation>Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Heldmann M, Scheich H, Bogerts B. Successful treatment of chronic resistant alcoholism by deep brain stimulation of nucleus accumbens: first experience with three cases. Pharmacopsychiatry. 2009 Nov;42(6):288-91. doi: 10.1055/s-0029-1233489. Epub 2009 Nov 18. No abstract available.</citation>
    <PMID>19924591</PMID>
  </reference>
  <reference>
    <citation>Craig AD. How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002 Aug;3(8):655-66. doi: 10.1038/nrn894.</citation>
    <PMID>12154366</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Joshua Brown, PHD</investigator_full_name>
    <investigator_title>Professor, Psychological and Brain Sciences</investigator_title>
  </responsible_party>
  <keyword>Nicotine Addiction</keyword>
  <keyword>Non-invasive deep brain stimulation</keyword>
  <keyword>Substance Use Disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Tobacco Use Disorder</mesh_term>
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will share anonymized participant data upon request. Beyond that, we will report anonymized data publicly in aggregate.</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/NCT04432064
org study id: 1904451651
nct id: NCT04432064
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This project aims to develop a line of research using new non-invasive neurostimulation
      technology to treat adults with opioid use disorders (OUDs). In the short term, the
      investigators aim to identify novel target brain regions for neurostimulation treatment and
      characterize their effects behaviorally and neurally. In the longer term, investigators aim
      to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial
      direct current stimulation and non-invasive deep brain stimulation to these areas to
      partially or completely disrupt addiction.
The investigators hypothesize that temporal interference non-invasive deep brain stimulation
      (TI-NDBS) will be well tolerated and effective at manipulating brain activity and reducing
      drug cravings. The investigators will investigate whether stimulation with a mild current
      from temporal interference non-invasive deep brain stimulation (TI-NDBS) to the Anterior
      Cingulate Cortex (ACC), the anterior insula (AI), or the nucleus accumbens (NAcc) will reduce
      nicotine craving and seeking. The TI-NDBS is similar to the traditional transcranial direct
      current stimulation (tDCS), a method approved for use in a number of other studies. Other
      studies have shown there have been some effects of reducing craving with tDCS, however, tDCS
      cannot stimulate structures such as the ACC very effectively because tDCS cannot stimulate
      deeper brain regions. Thus, the Specific Aim ultimately will compare TI-NDBS with tDCS and
      sham stimulation. The study is broken up into four phases. The first two will involve device
      feasibility and identifying the best locations for the electrodes to be placed. In the third
      phase, the investigators will compare TI-NDBS with sham stimulation. In the fourth phase, the
      investigators will compare TI-NDBS with sham stimulation and with tDCS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group of 20 participants will receive active TI-NDBS and another group of 20 participants will receive sham TI-NDBS. A third group of 20 participants will receive traditional transcranial direct current stimulation (tDCS).
primary purpose: Treatment
masking: Single (Participant)
masking description: This will be single-blind masking as the experimenter will need to know which intervention to run on the participant.
measure: Change in Nicotine craving
time frame: Within the first year of testing TI-NDBS in nicotine smokers.
description: The investigators predict that TI-NDBS will outperform sham stimulation at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with TI-NDBS vs tDCS. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving.
measure: Change in Nicotine craving due to TI-NDBS compared to tDCS
time frame: 1 year after the first primary outcome.
description: The investigators predict that TI-NDBS will outperform tDCS at an overall change in smoking and cigarette craving, which in turn will outperform sham stimulation. The investigators will sum the total inhaled nicotine vapor volume in liters over the 60 minute session and perform pairwise t-tests to determine if total drug intake is lower with one of the stimulation groups vs. sham. Also, the investigators will average the self reported craving levels on a Likert scale across each subject during the 60 minute session, and the investigators will perform pairwise tests to determine if stimulation lowers self reported craving.
arm group label: Phase 3 Active TI-NDBS
arm group type: Experimental
description: Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation. Participants will receive stimulation for 60 minutes on one day.
arm group label: Phase 3 Sham TI-NDBS
arm group type: Sham Comparator
description: Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds.
arm group label: Phase 4 Traditional tDCS
arm group type: Active Comparator
description: Participants assigned to this condition will receive traditional transcranial direct current stimulation for 60 minutes for 5 days.
arm group label: Phase 4 TI-NDBS
arm group type: Experimental
description: Participants assigned to this condition will receive active temporal interference non-invasive deep brain stimulation for 60 minutes for 5 days and will be compared to sham stimulation and tDCS.
arm group label: Phase 4 Sham stimulation
arm group type: Sham Comparator
description: Participants assigned to this condition will receive sham temporal interference non-invasive deep brain stimulation, in which they will have electrodes attached to the scalp but the device is only turned on for a few seconds. Participants will be in the scanner for 60 minutes for 5 days. This will be used as the control condition and compared with TI-NDBS and tDCS.
intervention type: Device
intervention name: Active TI-NDBS
description: In the active TI-NDBS condition, subjects will receive stimulation for 60 minutes applied to the brain through scalp electrodes. There will be a maximum of 2 mA per electrode pair and no single region will receive more than 2 mA because the currents will be administered to distinct regions. At the beginning of each stimulation period, the current will increase slowly at a constant rate for 30 seconds until it reaches the appropriate intensity. At the end of the stimulation, the current will decrease slowly for 30 seconds until it reaches zero.
arm group label: Phase 3 Active TI-NDBS
arm group label: Phase 4 TI-NDBS
other name: Temporal Interference Non-invasive Deep Brain Stimulation
intervention type: Other
intervention name: Sham TI-NDBS
description: This is the control condition in which participants will receive sham stimulation for 60 minutes.
arm group label: Phase 3 Sham TI-NDBS
arm group label: Phase 4 Sham stimulation
intervention type: Device
intervention name: tDCS
description: This is a well established method of brain stimulation and will be used to compare against the efficacy of TI-NDBS in the reduction of nicotine craving and inhalation. Participants will receive stimulation for 60 minutes.
arm group label: Phase 4 Traditional tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua Brown, PhD
phone: 812-855-9282
email: jwmbrown@indiana.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
PMID: 18312035
citation: Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.
PMID: 28575667
citation: Fecteau S, Agosta S, Hone-Blanchet A, Fregni F, Boggio P, Ciraulo D, Pascual-Leone A. Modulation of smoking and decision-making behaviors with transcranial direct current stimulation in tobacco smokers: a preliminary study. Drug Alcohol Depend. 2014 Jul 1;140:78-84. doi: 10.1016/j.drugalcdep.2014.03.036. Epub 2014 Apr 16.
PMID: 24814566
citation: Hulvershorn LA, Hummer TA, Fukunaga R, Leibenluft E, Finn P, Cyders MA, Anand A, Overhage L, Dir A, Brown J. Neural activation during risky decision-making in youth at high risk for substance use disorders. Psychiatry Res. 2015 Aug 30;233(2):102-11. doi: 10.1016/j.pscychresns.2015.05.007. Epub 2015 May 21.
PMID: 26071624
citation: Wing VC, Barr MS, Wass CE, Lipsman N, Lozano AM, Daskalakis ZJ, George TP. Brain stimulation methods to treat tobacco addiction. Brain Stimul. 2013 May;6(3):221-30. doi: 10.1016/j.brs.2012.06.008. Epub 2012 Jul 9.
PMID: 22809824
citation: Velez de Mendizabal N, Jones DR, Jahn A, Bies RR, Brown JW. Nicotine and cotinine exposure from electronic cigarettes: a population approach. Clin Pharmacokinet. 2015 Jun;54(6):615-26. doi: 10.1007/s40262-014-0221-7.
PMID: 25503588
citation: Naqvi NH, Rudrauf D, Damasio H, Bechara A. Damage to the insula disrupts addiction to cigarette smoking. Science. 2007 Jan 26;315(5811):531-4. doi: 10.1126/science.1135926.
PMID: 17255515
citation: Naqvi NH, Gaznick N, Tranel D, Bechara A. The insula: a critical neural substrate for craving and drug seeking under conflict and risk. Ann N Y Acad Sci. 2014 May;1316:53-70. doi: 10.1111/nyas.12415. Epub 2014 Apr 1.
PMID: 24690001
citation: Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Heldmann M, Scheich H, Bogerts B. Successful treatment of chronic resistant alcoholism by deep brain stimulation of nucleus accumbens: first experience with three cases. Pharmacopsychiatry. 2009 Nov;42(6):288-91. doi: 10.1055/s-0029-1233489. Epub 2009 Nov 18. No abstract available.
PMID: 19924591
citation: Craig AD. How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002 Aug;3(8):655-66. doi: 10.1038/nrn894.
PMID: 12154366
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Joshua Brown, PHD
investigator title: Professor, Psychological and Brain Sciences
mesh term: Substance-Related Disorders
mesh term: Tobacco Use Disorder
mesh term: Behavior, Addictive
sharing ipd: Yes
ipd description: We will share anonymized participant data upon request. Beyond that, we will report anonymized data publicly in aggregate.