<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/NCT02188914</url>
  </required_header>
  <id_info>
    <org_study_id>11/13 protocol</org_study_id>
    <nct_id>NCT02188914</nct_id>
  </id_info>
  <brief_title>Brain Imaging Studies of the Effect of Inhalant Use Disorder</brief_title>
  <official_title>Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miguel Ángel Mendoza Meléndez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurology and Neurosurgery, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inhalants substance misuse is an important public health problem whose prevalence is&#xD;
      approximately 1% in the general population and 7% among high school students in Mexico.&#xD;
      Furthermore Inhalants substance misuse has increased in the recent years (Villatoro et al.,&#xD;
      2011). According to the Diagnostic and Statistical Manual of Mental Disorders fifth edition&#xD;
      (DSM-5) inhalant use disorder is a problematic pattern of use of a hydrocarbon-based inhalant&#xD;
      substance leading to clinically significant impairment or distress. There are studies to&#xD;
      suggest that long-term exposure to inhalants is associated with structural brain&#xD;
      abnormalities, as well as neuropsychological impairments. However many of these studies have&#xD;
      been limited to the gross anatomical report, therefore is necessary the use of complimentary&#xD;
      techniques which provide a better understanding of brain. To the date there is no evidence of&#xD;
      the use of positron emission tomography, and there are few studies have employed other&#xD;
      magnetic resonance imaging methodologies such as diffusion tensor imaging that can be used to&#xD;
      know the metabolic activity and white matter tract integrity respectively in inhalant use&#xD;
      disorder participants. The purpose of this study is evaluates the effects of the inhalant use&#xD;
      disorder in the brain. The investigators will be using positron emission tomography (PET),&#xD;
      Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI). As well as, this study&#xD;
      will examine the impact of inhalants consumption on executive function performance and the&#xD;
      transcriptomic changes associated with inhalants consumption. The investigators hope that the&#xD;
      data gathered from this study will lead to the development of more effective treatments&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2014</start_date>
  <completion_date type="Actual">July 30, 2016</completion_date>
  <primary_completion_date type="Actual">July 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain metabolic activity</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abnormalities in the fractional anisotropy</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavioral performance measures on the executive functions</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the inhalant use disorder participants show neuropsychological impairments relative to healthy controls in attention and executive functions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity inhalant use disorder</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the brain metabolic activity is associated with the severity inhalant use disorder.&#xD;
Determine if the abnormalities in the fractional anisotropy are associated with the severity inhalant use disorder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ratings and scores in the Pittsburgh Sleep Quality Index</measure>
    <time_frame>Baseline</time_frame>
    <description>The proportion of participants that have good or bad sleep Quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Age at which inhalants use began</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the brain metabolic activity is associated with the age at which inhalants use began.&#xD;
Determine if the abnormalities in the fractional anisotropy are associated with the age at which inhalants use began.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of regular inhalant use</measure>
    <time_frame>Baseline</time_frame>
    <description>Determine if the brain metabolic activity is associated with the duration of regular inhalant use.&#xD;
Determine if the abnormalities in the fractional anisotropy are associated with the duration of regular inhalant use.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Inhalant Use Disorder</condition>
  <arm_group>
    <arm_group_label>Inhalant use disorder group</arm_group_label>
    <description>Subjects must have a diagnosis of inhalant use disorder, according to the DSM-5, who are under a treatment program for addictive disorders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal control group</arm_group_label>
    <description>Normal control without a history of drug abuse or dependency.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Positron emission tomography scan</intervention_name>
    <arm_group_label>Inhalant use disorder group</arm_group_label>
    <arm_group_label>Normal control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic resonance imaging</intervention_name>
    <arm_group_label>Inhalant use disorder group</arm_group_label>
    <arm_group_label>Normal control group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      cDNA obtained from reversal transcription of RNA isolated from periferical blood cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in inhalant use disorder treatment program or Normal Control Subjects&#xD;
        volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males between 18 to 40 years old.&#xD;
&#xD;
          -  Subjects must have a diagnosis of inhalant use disorder who are under a treatment&#xD;
             program for addictive disorders or normal control without a history of drug abuse or&#xD;
             dependency. Control participants must be matches with the inhalant use disorder&#xD;
             participants according to age and years of education.&#xD;
&#xD;
          -  Subjects in both the inhalant use disorder and control groups will be volunteers who&#xD;
             signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy or clinically relevant seizures in the last year&#xD;
&#xD;
          -  Cognitive impairment evaluated through Mini-Mental State Examination&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Manic or hypomanic episode&#xD;
&#xD;
          -  Moderate or severe suicide risk&#xD;
&#xD;
          -  Panic disorder&#xD;
&#xD;
          -  Claustrophobia: Subjects will be questioned about their potential discomfort in being&#xD;
             in an enclosed space, such as a PET or MRI scanner.&#xD;
&#xD;
          -  History of head trauma with loss of consciousness &gt; 30 min.&#xD;
&#xD;
          -  Neurological surgical procedures&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Positive test for hippuric acid&#xD;
&#xD;
          -  Current use of antipsychotic medication&#xD;
&#xD;
          -  Current illnesses, painful conditions or other disorders, which in the judgment of the&#xD;
             investigators, might invalidate the scientific goals of the study or pose undesirable&#xD;
             difficulties or risks for subjects&#xD;
&#xD;
          -  In the case for magnetic resonance imaging, Individuals who would be unable to undergo&#xD;
             a MRI scan, for example, individuals who have metal clips in their body, metallic&#xD;
             prostheses (i.e., replacement body parts, such as a hip joint), a pacemaker, or other&#xD;
             pieces of metal in their body (shrapnel, metal filings, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Ángel Mendoza Meléndez, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Attention and Prevention of Addictions in Mexico City</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nora Estela Kerik Rotenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Neurology and Neurosurgery Manuel Velasco Suarez</name>
      <address>
        <city>Mexico city</city>
        <zip>14269</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Villatoro JA, Cruz SL, Ortiz A, Medina-Mora ME. Volatile substance misuse in Mexico: correlates and trends. Subst Use Misuse. 2011;46 Suppl 1:40-5. doi: 10.3109/10826084.2011.580205.</citation>
    <PMID>21609144</PMID>
  </reference>
  <reference>
    <citation>Yucel M, Takagi M, Walterfang M, Lubman DI. Toluene misuse and long-term harms: a systematic review of the neuropsychological and neuroimaging literature. Neurosci Biobehav Rev. 2008 Jul;32(5):910-26. doi: 10.1016/j.neubiorev.2008.01.006. Epub 2008 Mar 27.</citation>
    <PMID>18456329</PMID>
  </reference>
  <reference>
    <citation>Aydin K, Sencer S, Demir T, Ogel K, Tunaci A, Minareci O. Cranial MR findings in chronic toluene abuse by inhalation. AJNR Am J Neuroradiol. 2002 Aug;23(7):1173-9.</citation>
    <PMID>12169477</PMID>
  </reference>
  <reference>
    <citation>Brouette T, Anton R. Clinical review of inhalants. Am J Addict. 2001 Winter;10(1):79-94. doi: 10.1080/105504901750160529.</citation>
    <PMID>11268830</PMID>
  </reference>
  <reference>
    <citation>Takagi M, Lubman DI, Walterfang M, Barton S, Reutens D, Wood A, Yucel M. Corpus callosum size and shape alterations in adolescent inhalant users. Addict Biol. 2013 Sep;18(5):851-4. doi: 10.1111/j.1369-1600.2011.00364.x. Epub 2011 Sep 29.</citation>
    <PMID>21955104</PMID>
  </reference>
  <reference>
    <citation>Yucel M, Zalesky A, Takagi MJ, Bora E, Fornito A, Ditchfield M, Egan GF, Pantelis C, Lubman DI. White-matter abnormalities in adolescents with long-term inhalant and cannabis use: a diffusion magnetic resonance imaging study. J Psychiatry Neurosci. 2010 Nov;35(6):409-12. doi: 10.1503/jpn.090177.</citation>
    <PMID>20731960</PMID>
  </reference>
  <reference>
    <citation>Volkow ND, Fowler JS, Wang GJ. Positron emission tomography and single-photon emission computed tomography in substance abuse research. Semin Nucl Med. 2003 Apr;33(2):114-28. doi: 10.1053/snuc.2003.127300.</citation>
    <PMID>12756644</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México</investigator_affiliation>
    <investigator_full_name>Miguel Ángel Mendoza Meléndez</investigator_full_name>
    <investigator_title>Director of Research and Evaluation</investigator_title>
  </responsible_party>
  <keyword>Inhalant use disorder</keyword>
  <keyword>Positron emission tomography</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Executive functions assessment</keyword>
  <keyword>Transcriptome</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/NCT02188914
org study id: 11/13 protocol
nct id: NCT02188914
lead sponsor: 
collaborator: 
has dmc: Yes
Inhalants substance misuse is an important public health problem whose prevalence is
      approximately 1% in the general population and 7% among high school students in Mexico.
      Furthermore Inhalants substance misuse has increased in the recent years (Villatoro et al.,
      2011). According to the Diagnostic and Statistical Manual of Mental Disorders fifth edition
      (DSM-5) inhalant use disorder is a problematic pattern of use of a hydrocarbon-based inhalant
      substance leading to clinically significant impairment or distress. There are studies to
      suggest that long-term exposure to inhalants is associated with structural brain
      abnormalities, as well as neuropsychological impairments. However many of these studies have
      been limited to the gross anatomical report, therefore is necessary the use of complimentary
      techniques which provide a better understanding of brain. To the date there is no evidence of
      the use of positron emission tomography, and there are few studies have employed other
      magnetic resonance imaging methodologies such as diffusion tensor imaging that can be used to
      know the metabolic activity and white matter tract integrity respectively in inhalant use
      disorder participants. The purpose of this study is evaluates the effects of the inhalant use
      disorder in the brain. The investigators will be using positron emission tomography (PET),
      Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI). As well as, this study
      will examine the impact of inhalants consumption on executive function performance and the
      transcriptomic changes associated with inhalants consumption. The investigators hope that the
      data gathered from this study will lead to the development of more effective treatments
observational model: Case-Control
time perspective: Cross-Sectional
measure: Brain metabolic activity
time frame: Baseline
description: Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls
measure: Abnormalities in the fractional anisotropy
time frame: Baseline
description: Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls
measure: Behavioral performance measures on the executive functions
time frame: Baseline
description: Determine if the inhalant use disorder participants show neuropsychological impairments relative to healthy controls in attention and executive functions
measure: Severity inhalant use disorder
time frame: Baseline
description: Determine if the brain metabolic activity is associated with the severity inhalant use disorder.
Determine if the abnormalities in the fractional anisotropy are associated with the severity inhalant use disorder.
measure: Ratings and scores in the Pittsburgh Sleep Quality Index
time frame: Baseline
description: The proportion of participants that have good or bad sleep Quality.
measure: Age at which inhalants use began
time frame: Baseline
description: Determine if the brain metabolic activity is associated with the age at which inhalants use began.
Determine if the abnormalities in the fractional anisotropy are associated with the age at which inhalants use began.
measure: Duration of regular inhalant use
time frame: Baseline
description: Determine if the brain metabolic activity is associated with the duration of regular inhalant use.
Determine if the abnormalities in the fractional anisotropy are associated with the duration of regular inhalant use.
arm group label: Inhalant use disorder group
description: Subjects must have a diagnosis of inhalant use disorder, according to the DSM-5, who are under a treatment program for addictive disorders.
arm group label: Normal control group
description: Normal control without a history of drug abuse or dependency.
intervention type: Radiation
intervention name: Positron emission tomography scan
arm group label: Inhalant use disorder group
arm group label: Normal control group
intervention type: Other
intervention name: Magnetic resonance imaging
arm group label: Inhalant use disorder group
arm group label: Normal control group
cDNA obtained from reversal transcription of RNA isolated from periferical blood cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Miguel Ángel Mendoza Meléndez, MD, MPH
role: Principal Investigator
affiliation: Institute for Attention and Prevention of Addictions in Mexico City
last name: Nora Estela Kerik Rotenberg, MD
role: Principal Investigator
affiliation: National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.
facility: 
country: Mexico
citation: Villatoro JA, Cruz SL, Ortiz A, Medina-Mora ME. Volatile substance misuse in Mexico: correlates and trends. Subst Use Misuse. 2011;46 Suppl 1:40-5. doi: 10.3109/10826084.2011.580205.
PMID: 21609144
citation: Yucel M, Takagi M, Walterfang M, Lubman DI. Toluene misuse and long-term harms: a systematic review of the neuropsychological and neuroimaging literature. Neurosci Biobehav Rev. 2008 Jul;32(5):910-26. doi: 10.1016/j.neubiorev.2008.01.006. Epub 2008 Mar 27.
PMID: 18456329
citation: Aydin K, Sencer S, Demir T, Ogel K, Tunaci A, Minareci O. Cranial MR findings in chronic toluene abuse by inhalation. AJNR Am J Neuroradiol. 2002 Aug;23(7):1173-9.
PMID: 12169477
citation: Brouette T, Anton R. Clinical review of inhalants. Am J Addict. 2001 Winter;10(1):79-94. doi: 10.1080/105504901750160529.
PMID: 11268830
citation: Takagi M, Lubman DI, Walterfang M, Barton S, Reutens D, Wood A, Yucel M. Corpus callosum size and shape alterations in adolescent inhalant users. Addict Biol. 2013 Sep;18(5):851-4. doi: 10.1111/j.1369-1600.2011.00364.x. Epub 2011 Sep 29.
PMID: 21955104
citation: Yucel M, Zalesky A, Takagi MJ, Bora E, Fornito A, Ditchfield M, Egan GF, Pantelis C, Lubman DI. White-matter abnormalities in adolescents with long-term inhalant and cannabis use: a diffusion magnetic resonance imaging study. J Psychiatry Neurosci. 2010 Nov;35(6):409-12. doi: 10.1503/jpn.090177.
PMID: 20731960
citation: Volkow ND, Fowler JS, Wang GJ. Positron emission tomography and single-photon emission computed tomography in substance abuse research. Semin Nucl Med. 2003 Apr;33(2):114-28. doi: 10.1053/snuc.2003.127300.
PMID: 12756644
responsible party type: Sponsor-Investigator
investigator affiliation: Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México
investigator full name: Miguel Ángel Mendoza Meléndez
investigator title: Director of Research and Evaluation