<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/NCT01679444</url>
  </required_header>
  <id_info>
    <org_study_id>12-003693</org_study_id>
    <nct_id>NCT01679444</nct_id>
  </id_info>
  <brief_title>MRS Probe Study of Alcohol</brief_title>
  <official_title>Magnetic Resonance Spectroscopy Probe Study of Alcohol Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol will investigate the neurobiological underpinnings of alcohol craving in&#xD;
      recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This&#xD;
      clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and&#xD;
      other brain metabolites correlate to measures of alcohol craving severity&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Utilizing Magnetic Resonance Spectroscopy at 3 Tesla, investigate the neurobiological underpinnings of alcohol craving</measure>
    <description>assessing baseline perturbations in anterior cingulate and ventral striatal metabolites (NAA levels, glutamate levels, glutamine levels)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the relationship between these metabolites, each reported as a Cerebrospinal Fluid-corrected absolute concentration, and severity of alcohol cravings</measure>
    <description>Evaluate the relationship between these metabolites, each reported as a Cerebrospinal fluid-corrected absolute concentration, and severity of alcohol cravings, as measured primarily by the Penn Alcohol Craving Scale and secondarily by the Inventory of Drug Taking Situations.</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Heavy Dose Drinkers</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Spectroscopy</intervention_name>
    <other_name>MRS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: (Minimal or No Alcohol Group)&#xD;
&#xD;
          1. Male or female age 21-70&#xD;
&#xD;
          2. Consume less alcohol then what is described in this protocol as a &quot;higher dose&#xD;
             drinker&quot;, or consume no alcohol at all.&#xD;
&#xD;
          3. Able to complete a 60 min. MRS brain scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to speak English&#xD;
&#xD;
          2. Inability or unwillingness to provide written informed consent&#xD;
&#xD;
          3. Diagnosis of active substance dependence other than nicotine (e.g. alcohol, cannabis,&#xD;
             caffeine, prescription use of barbiturates, benzodiazepines, opiates, or stimulants)&#xD;
             this will be determined using a PRISM (Psychiatric Research Interview for Substance&#xD;
             and Mental Disorders) interview.&#xD;
&#xD;
          4. Any unstable active medical or additional psychiatric condition as determined by the&#xD;
             investigator&#xD;
&#xD;
          5. Active suicidal ideation as determined by the PHQ-9 question 9 indicating response #2&#xD;
             or higher (several days; more than half the days; or nearly every day).&#xD;
&#xD;
          6. History of encephalopathy, hepatic failure, or HIV seropositivity&#xD;
&#xD;
          7. History of claustrophobia&#xD;
&#xD;
          8. History of major head trauma with loss of consciousness &gt;5 minutes or skull fracture&#xD;
&#xD;
          9. History of previous neurological event (e.g. epilepsy, stroke, transient ischemic&#xD;
             attack)&#xD;
&#xD;
         10. Implanted metal objects (e.g. pacemakers; aneurysm clips; metal prostheses, joints,&#xD;
             rods, or plates)&#xD;
&#xD;
         11. Contraindication to MRI scanning&#xD;
&#xD;
         12. Pregnancy or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Frye, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>June 27, 2014</last_update_submitted>
  <last_update_submitted_qc>June 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Mark Frye</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>MRS</keyword>
  <keyword>Heavy dose drinkers</keyword>
  <keyword>Alcohol</keyword>
  <keyword>NIAAA</keyword>
  <!-- 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/NCT01679444
org study id: 12-003693
nct id: NCT01679444
lead sponsor: 
has dmc: No
This protocol will investigate the neurobiological underpinnings of alcohol craving in
      recently detoxified alcoholic drinkers utilizing novel functional brain imaging. This
      clinical magnetic resonance spectroscopy (MRS) study will investigate whether glutamate and
      other brain metabolites correlate to measures of alcohol craving severity
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Utilizing Magnetic Resonance Spectroscopy at 3 Tesla, investigate the neurobiological underpinnings of alcohol craving
description: assessing baseline perturbations in anterior cingulate and ventral striatal metabolites (NAA levels, glutamate levels, glutamine levels)
measure: Evaluate the relationship between these metabolites, each reported as a Cerebrospinal Fluid-corrected absolute concentration, and severity of alcohol cravings
description: Evaluate the relationship between these metabolites, each reported as a Cerebrospinal fluid-corrected absolute concentration, and severity of alcohol cravings, as measured primarily by the Penn Alcohol Craving Scale and secondarily by the Inventory of Drug Taking Situations.
intervention type: Procedure
intervention name: Magnetic Resonance Spectroscopy
other name: MRS
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Frye, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Mark Frye
investigator title: Principal Investigator