xml: <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/NCT05974202</url>
    </required_header>
    <id_info>
      <org_study_id>UG3DA056138</org_study_id>
      <nct_id>NCT05974202</nct_id>
    </id_info>
    <brief_title>rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder</brief_title>
    <official_title>Augmenting Cognitive-behavioral Therapy With rTMS of the Medial Prefrontal and Anterior Cingulate Cortices for the Treatment of Cocaine Use Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New York State Psychiatric Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>New York State Psychiatric Institute</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_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the effects of active repetitive transcranial&#xD;
        magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy&#xD;
        (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use&#xD;
             disorder?&#xD;
  &#xD;
          -  What is the brain mechanism of rTMS?&#xD;
  &#xD;
          -  Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use&#xD;
             disorder achieve abstinence from cocaine?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Have two brain MRI scans;&#xD;
  &#xD;
          -  Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and;&#xD;
  &#xD;
          -  Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine&#xD;
             use disorder.&#xD;
  &#xD;
        Researchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will&#xD;
        receive cognitive-behavioral therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cocaine use disorder (CUD) remains a significant public health problem given that many&#xD;
        patients fail to respond to existing therapies (Dutra et al., 2008). Treatment refractory CUD&#xD;
        may be explained, in part, by abnormal neurocircuitry. The medial prefrontal cortex (mPFC)&#xD;
        and dorsal anterior cingulate cortex (dACC) have demonstrated altered functioning in CUD&#xD;
        (Hanlon et al., 2016). Compared to controls, participants with CUD show consistent changes to&#xD;
        the mPFC/dACC, including hypoactivation during cognitive and attentional tasks (Bolla et al.,&#xD;
        2003; Kaufman et al., 2003; Kubler et al., 2005), hyperactivation during drug cue exposure&#xD;
        (Garavan et al., 2000; Grant et al., 1996), and lower grey matter volumes (Ersche et al.,&#xD;
        2011; Matochik et al., 2003).&#xD;
  &#xD;
        Imaging studies also show that these alterations in the mPFC/dACC are associated with an&#xD;
        impaired response to treatment. Hypoactivation of the mPFC/dACC region of the fronto-cingular&#xD;
        network during the Color-Word Stroop task, a measure of cognitive interference and response&#xD;
        inhibition, is associated with faster relapse rates (Brewer et al., 2008). Greater activation&#xD;
        of the fronto-cingular network during incongruent stimuli on the Stroop task is also&#xD;
        associated with poorer outcomes in CUD participants receiving cognitive behavioral therapy&#xD;
        (CBT) (Worhunsky et al., 2013). When using the Drug Stroop task, better performance was&#xD;
        associated with a longer duration of cocaine abstinence during CBT (DeVito et al., 2018).&#xD;
        Thus, processing deficits across these brain regions likely contribute to the limited success&#xD;
        of behavioral interventions for CUD, resulting in high dropout rates and a lack of treatment&#xD;
        response.&#xD;
  &#xD;
        Our goal is to target the mPFC/dACC with repetitive transcranial magnetic stimulation (rTMS)&#xD;
        to investigate its impact on neurocognitive function and response to treatment in CUD. We&#xD;
        will use the H7-coil, which targets the mPFC/dACC and has been FDA-cleared as a treatment for&#xD;
        obsessive-compulsive disorder (Carmi et al., 2019). Previous work by our group showed that&#xD;
        high-frequency (10 Hz) rTMS with the H7-coil led to a significant reduction in choices for&#xD;
        cocaine in the human laboratory setting (Martinez et al., 2018). Additional studies using&#xD;
        rTMS for CUD have targeted the dorsolateral or ventromedial PFC and demonstrated reduction in&#xD;
        craving and drug cue reactivity (Ekhtiari et al., 2019; Antonelli et al., 2021; Kearney-Ramos&#xD;
        et al., 2018; Kearney-Ramos et al., 2019).&#xD;
  &#xD;
        Despite these promising findings, sham-controlled clinical trials investigating the effect of&#xD;
        rTMS on abstinence and cocaine consumption are lacking. In this trial, our goal is to&#xD;
        investigate rTMS as a potential treatment for CUD. Treatment-seeking volunteers with&#xD;
        moderate/severe CUD will undergo three weeks (15 daily sessions) of outpatient, randomized,&#xD;
        double-blinded, sham-controlled, high-frequency (10 Hz) rTMS to the mPFC/dACC with the&#xD;
        H7-coil followed by standardized CBT. We will evaluate feasibility, safety, and the effect of&#xD;
        rTMS on the mPFC/dACC using functional magnetic resonance imaging (fMRI) and clinical outcome&#xD;
        measures (cocaine use). This outcome data will inform a larger clinical trial to evaluate&#xD;
        rTMS as an augmentation for CBT outcomes in moderate/severe CUD and further explore the&#xD;
        associated neural mechanisms of rTMS in this clinical population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
    <phase>Phase 2</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>Active high-frequency stimulation vs. sham (placebo) stimulation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants receiving at least 10 out of 15 rTMS sessions</measure>
      <time_frame>3 weeks</time_frame>
      <description>Feasibility will be measured as the total percentage of participants who receive the defined number of rTMS sessions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants in the active rTMS arm experiencing an rTMS-emergent adverse event</measure>
      <time_frame>3 weeks</time_frame>
      <description>Safety of rTMS will be measured by the absolute number of serious adverse events that occur in the active rTMS arm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent change of medial prefrontal cortex and dorsal anterior cingulate cortex activity on fMRI during the Drug Stroop Task</measure>
      <time_frame>3 weeks</time_frame>
      <description>Neural mechanism will be evaluated by comparing the active and sham rTMS groups during the fMRI task by comparing baseline fMRI and post-rTMS fMRI measures</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of participants who achieve 3 weeks of abstinence during the final 12 weeks of the trial</measure>
      <time_frame>12 weeks</time_frame>
      <description>Efficacy regarding cocaine use outcomes will be evaluated by comparing the active and sham rTMS groups during the final 12 weeks of the trial while the participants are receiving cognitive behavioral therapy. 3 weeks of consecutive abstinence is defined as: 1. No cocaine use is self-reported per timeline followback; 2. At least 6 urine drug screens are completed during the 3 weeks of continuous abstinence, and all are negative (with the exception of any positive urine in the first 4 days of the first week of the three weeks of self-reported abstinence, as urine may remain positive for up to 4 days after an episode of use), and; 3. At least 1 urine drug screen is completed each week during the 3 weeks of self-reported continuous abstinence.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cocaine Use</condition>
    <condition>Cocaine Dependence</condition>
    <condition>Cocaine Use Disorder</condition>
    <condition>Cocaine Use Disorder, Moderate</condition>
    <condition>Cocaine Use Disorder, Severe</condition>
    <arm_group>
      <arm_group_label>Active (high-frequency) rTMS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Daily high-frequency (10 Hz) repetitive transcranial magnetic brain stimulation for 3 weeks (15 sessions).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham (placebo) rTMS</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Active H7-coil repetitive transcranial magnetic stimulation (rTMS)</intervention_name>
      <description>A magnetic current created by the device creates an electrical current in the brain to stimulate the medial prefrontal cortex and dorsal anterior cingulate cortex.</description>
      <arm_group_label>Active (high-frequency) rTMS</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)</intervention_name>
      <description>A sham coil is in the same helmet as the active coil. The sham coil mimics the sound, scalp sensations, and facial muscle activation caused by the active coil, but does not create an electrical current in the brain.</description>
      <arm_group_label>Sham (placebo) rTMS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-65;&#xD;
  &#xD;
            2. Able to give informed consent and comply with study procedures;&#xD;
  &#xD;
            3. Meets DSM-5 criteria for current moderate/severe CUD and are treatment-seeking;&#xD;
  &#xD;
            4. Used cocaine at least 9 days in the past 28 days, with at least weekly cocaine use;&#xD;
  &#xD;
            5. Agree to no more than moderate alcohol consumption (&lt;15 drinks/week for men and &lt;8&#xD;
               drinks/week for women) and to avoid using amphetamine/methamphetamine and&#xD;
               non-prescribed benzodiazepines or barbiturates; and&#xD;
  &#xD;
            6. Women of childbearing potential must agree to use a method of contraception with&#xD;
               proven efficacy and agree to not become pregnant during the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Meets DSM-5 criteria for current moderate/severe major depressive episode, OCD,&#xD;
               bipolar disorder, schizophrenia or any psychotic disorder other than transient&#xD;
               psychosis due to substance use;&#xD;
  &#xD;
            2. Hamilton Depression Rating Scale score &gt; 17;&#xD;
  &#xD;
            3. Young Mania Rating Scale score &gt;10;&#xD;
  &#xD;
            4. Meets DSM-5 criteria for current moderate/severe other substance use disorder (aside&#xD;
               from tobacco use disorder; physiologic dependence on any other substance other than&#xD;
               nicotine, including alcohol, is exclusionary);&#xD;
  &#xD;
            5. Heavy weekly alcohol drinking as defined by an average of &gt;14 drinks/week for men or&#xD;
               &gt;7 drinks/week for women on average during the past 28 days;&#xD;
  &#xD;
            6. Prior alcohol, benzodiazepine, or barbiturate withdrawal that resulted in&#xD;
               hospitalization, medical detoxification, or resulted in seizures or delirium tremens;&#xD;
  &#xD;
            7. More than twice weekly use of non-prescribed medications/drugs that may change the&#xD;
               seizure threshold, including benzodiazepines, barbiturates, GHB/GBL,&#xD;
               amphetamines/methamphetamine;&#xD;
  &#xD;
            8. Any other current DSM-5 psychiatric disorder(s) that in the investigator's judgment&#xD;
               are unstable, would be disrupted by study procedures, or are likely to require&#xD;
               pharmacotherapy or psychotherapy during the study period;&#xD;
  &#xD;
            9. Significant current suicide risk, indicated by either: (1) &quot;yes&quot; response on #3, 4, or&#xD;
               #5 on the C-SSRS and a psychiatric risk assessment indicating a moderate or high risk&#xD;
               of suicide or (2) suicidal behavior in the past 3 months (note: non-suicidal&#xD;
               self-injurious behavior is not exclusionary);&#xD;
  &#xD;
           10. Females with a positive urine pregnancy test;&#xD;
  &#xD;
           11. Clinically significant abnormal cardiac functioning per electrocardiogram (ECG)&#xD;
               (required for any participant age 60 years and older);&#xD;
  &#xD;
           12. Seizure history including: seizure disorder/epilepsy, alcohol/drug withdrawal seizure,&#xD;
               or seizure deemed by the study physician to be related to cocaine&#xD;
               intoxication/withdrawal (note: febrile seizures are not exclusionary)&#xD;
  &#xD;
           13. Other medical conditions that are relatively contraindicated with TMS (seizure&#xD;
               disorders, glaucoma, increased intracranial pressure, severe migraines, stroke, brain&#xD;
               lesions, pregnancy or breast-feeding, neurodegenerative disease, meningoencephalitis,&#xD;
               intracerebral abscess, parenchymal or leptomeningeal cancers);&#xD;
  &#xD;
           14. Medications that lower seizure threshold and in the opinion of the investigator impose&#xD;
               significant seizure risk for the individual;&#xD;
  &#xD;
           15. Cognitive disorder (MMSE &lt;25);&#xD;
  &#xD;
           16. Disqualifying response on the TMS Adult Safety Screen (TASS);&#xD;
  &#xD;
           17. Implanted devices or stimulators (cardiac pacemakers, vagus nerve stimulators, spinal&#xD;
               cord stimulators, cochlear implant);&#xD;
  &#xD;
           18. Currently taking ototoxic medications (aminoglycosides, cisplatin);&#xD;
  &#xD;
           19. Metal implants or paramagnetic objects in the body that prohibits MR scanning;&#xD;
  &#xD;
           20. Claustrophobia that prohibits MR scanning; or&#xD;
  &#xD;
           21. Legally mandated (e.g., to avoid incarceration or other penalties) to participate in&#xD;
               SUD treatment program.&#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>Derek Blevins, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>New York State Psychiatric Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Daniel Brooks, MSW</last_name>
      <phone>646-774-8181</phone>
      <email>daniel.brooks@nyspi.columbia.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elizabeth Martinez</last_name>
      <phone>212-923-3031</phone>
      <email>elizabeth.martinez@nyspi.columbia.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
      <investigator_full_name>Derek Blevins</investigator_full_name>
      <investigator_title>Assistant Professor / Clinical Psychologist</investigator_title>
    </responsible_party>
    <keyword>Repetitive transcranial magnetic stimulation</keyword>
    <keyword>rTMS</keyword>
    <keyword>TMS</keyword>
    <keyword>Cognitive behavioral therapy</keyword>
    <keyword>CBT</keyword>
    <keyword>Functional magnetic resonance imaging</keyword>
    <keyword>fMRI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cocaine-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Beginning twelve months and ending 5 years after article publication.</ipd_time_frame>
      <ipd_access_criteria>To researcher who provides a methodologically sound proposal to achieve aims in approved proposal.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974202
  org study id: UG3DA056138
  nct id: NCT05974202
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this clinical trial is to compare the effects of active repetitive transcranial
        magnetic stimulation (rTMS) to sham (placebo) rTMS prior to cognitive-behavioral therapy
        (CBT) as a treatment for adults with cocaine use disorder. The main questions it aims to
        answer are:
  
          -  Is rTMS safe and feasible as an augmentation for CBT for the treatment of cocaine use
             disorder?
  
          -  What is the brain mechanism of rTMS?
  
          -  Will active rTMS (compared to sham rTMS) followed by CBT help adults with cocaine use
             disorder achieve abstinence from cocaine?
  
        Participants will:
  
          -  Have two brain MRI scans;
  
          -  Undergo 3 weeks of daily rTMS (or sham) treatments (15 sessions), and;
  
          -  Have 12 weeks of once-weekly cognitive-behavioral therapy for the treatment of cocaine
             use disorder.
  
        Researchers will compare active (real) rTMS to sham (placebo) rTMS. All participants will
        receive cognitive-behavioral therapy.
  Cocaine use disorder (CUD) remains a significant public health problem given that many
        patients fail to respond to existing therapies (Dutra et al., 2008). Treatment refractory CUD
        may be explained, in part, by abnormal neurocircuitry. The medial prefrontal cortex (mPFC)
        and dorsal anterior cingulate cortex (dACC) have demonstrated altered functioning in CUD
        (Hanlon et al., 2016). Compared to controls, participants with CUD show consistent changes to
        the mPFC/dACC, including hypoactivation during cognitive and attentional tasks (Bolla et al.,
        2003; Kaufman et al., 2003; Kubler et al., 2005), hyperactivation during drug cue exposure
        (Garavan et al., 2000; Grant et al., 1996), and lower grey matter volumes (Ersche et al.,
        2011; Matochik et al., 2003).
  
        Imaging studies also show that these alterations in the mPFC/dACC are associated with an
        impaired response to treatment. Hypoactivation of the mPFC/dACC region of the fronto-cingular
        network during the Color-Word Stroop task, a measure of cognitive interference and response
        inhibition, is associated with faster relapse rates (Brewer et al., 2008). Greater activation
        of the fronto-cingular network during incongruent stimuli on the Stroop task is also
        associated with poorer outcomes in CUD participants receiving cognitive behavioral therapy
        (CBT) (Worhunsky et al., 2013). When using the Drug Stroop task, better performance was
        associated with a longer duration of cocaine abstinence during CBT (DeVito et al., 2018).
        Thus, processing deficits across these brain regions likely contribute to the limited success
        of behavioral interventions for CUD, resulting in high dropout rates and a lack of treatment
        response.
  
        Our goal is to target the mPFC/dACC with repetitive transcranial magnetic stimulation (rTMS)
        to investigate its impact on neurocognitive function and response to treatment in CUD. We
        will use the H7-coil, which targets the mPFC/dACC and has been FDA-cleared as a treatment for
        obsessive-compulsive disorder (Carmi et al., 2019). Previous work by our group showed that
        high-frequency (10 Hz) rTMS with the H7-coil led to a significant reduction in choices for
        cocaine in the human laboratory setting (Martinez et al., 2018). Additional studies using
        rTMS for CUD have targeted the dorsolateral or ventromedial PFC and demonstrated reduction in
        craving and drug cue reactivity (Ekhtiari et al., 2019; Antonelli et al., 2021; Kearney-Ramos
        et al., 2018; Kearney-Ramos et al., 2019).
  
        Despite these promising findings, sham-controlled clinical trials investigating the effect of
        rTMS on abstinence and cocaine consumption are lacking. In this trial, our goal is to
        investigate rTMS as a potential treatment for CUD. Treatment-seeking volunteers with
        moderate/severe CUD will undergo three weeks (15 daily sessions) of outpatient, randomized,
        double-blinded, sham-controlled, high-frequency (10 Hz) rTMS to the mPFC/dACC with the
        H7-coil followed by standardized CBT. We will evaluate feasibility, safety, and the effect of
        rTMS on the mPFC/dACC using functional magnetic resonance imaging (fMRI) and clinical outcome
        measures (cocaine use). This outcome data will inform a larger clinical trial to evaluate
        rTMS as an augmentation for CBT outcomes in moderate/severe CUD and further explore the
        associated neural mechanisms of rTMS in this clinical population.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Active high-frequency stimulation vs. sham (placebo) stimulation
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Double-blind
  measure: Percentage of participants receiving at least 10 out of 15 rTMS sessions
  time frame: 3 weeks
  description: Feasibility will be measured as the total percentage of participants who receive the defined number of rTMS sessions
  measure: Number of participants in the active rTMS arm experiencing an rTMS-emergent adverse event
  time frame: 3 weeks
  description: Safety of rTMS will be measured by the absolute number of serious adverse events that occur in the active rTMS arm
  measure: Percent change of medial prefrontal cortex and dorsal anterior cingulate cortex activity on fMRI during the Drug Stroop Task
  time frame: 3 weeks
  description: Neural mechanism will be evaluated by comparing the active and sham rTMS groups during the fMRI task by comparing baseline fMRI and post-rTMS fMRI measures
  measure: Percentage of participants who achieve 3 weeks of abstinence during the final 12 weeks of the trial
  time frame: 12 weeks
  description: Efficacy regarding cocaine use outcomes will be evaluated by comparing the active and sham rTMS groups during the final 12 weeks of the trial while the participants are receiving cognitive behavioral therapy. 3 weeks of consecutive abstinence is defined as: 1. No cocaine use is self-reported per timeline followback; 2. At least 6 urine drug screens are completed during the 3 weeks of continuous abstinence, and all are negative (with the exception of any positive urine in the first 4 days of the first week of the three weeks of self-reported abstinence, as urine may remain positive for up to 4 days after an episode of use), and; 3. At least 1 urine drug screen is completed each week during the 3 weeks of self-reported continuous abstinence.
  arm group label: Active (high-frequency) rTMS
  arm group type: Active Comparator
  description: Daily high-frequency (10 Hz) repetitive transcranial magnetic brain stimulation for 3 weeks (15 sessions).
  arm group label: Sham (placebo) rTMS
  arm group type: Placebo Comparator
  description: Sham rTMS uses the same device and mimics the auditory and scalp sensations without stimulating the brain.
  intervention type: Device
  intervention name: Active H7-coil repetitive transcranial magnetic stimulation (rTMS)
  description: A magnetic current created by the device creates an electrical current in the brain to stimulate the medial prefrontal cortex and dorsal anterior cingulate cortex.
  arm group label: Active (high-frequency) rTMS
  intervention type: Device
  intervention name: Sham H7-coil repetitive transcranial magnetic stimulation (rTMS)
  description: A sham coil is in the same helmet as the active coil. The sham coil mimics the sound, scalp sensations, and facial muscle activation caused by the active coil, but does not create an electrical current in the brain.
  arm group label: Sham (placebo) rTMS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Derek Blevins, MD
  role: Principal Investigator
  affiliation: New York State Psychiatric Institute
  last name: Daniel Brooks, MSW
  phone: 646-774-8181
  email: daniel.brooks@nyspi.columbia.edu
  last name: Elizabeth Martinez
  phone: 212-923-3031
  email: elizabeth.martinez@nyspi.columbia.edu
  responsible party type: Principal Investigator
  investigator affiliation: New York State Psychiatric Institute
  investigator full name: Derek Blevins
  investigator title: Assistant Professor / Clinical Psychologist
  mesh term: Cocaine-Related Disorders
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures).
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Beginning twelve months and ending 5 years after article publication.
  ipd access criteria: To researcher who provides a methodologically sound proposal to achieve aims in approved proposal.