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Brain Imaging Studies of the Effect of Inhalant Use Disorder

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ClinicalTrials.gov Identifier: NCT02188914
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : August 17, 2017
Sponsor:
Collaborator:
National Institute of Neurology and Neurosurgery, Mexico
Information provided by (Responsible Party):
Miguel Ángel Mendoza Meléndez, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México

Brief Summary:
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

Condition or disease Intervention/treatment
Inhalant Use Disorder Radiation: Positron emission tomography scan Other: Magnetic resonance imaging

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Inhalant use disorder group
Subjects must have a diagnosis of inhalant use disorder, according to the DSM-5, who are under a treatment program for addictive disorders.
Radiation: Positron emission tomography scan
Other: Magnetic resonance imaging
Normal control group
Normal control without a history of drug abuse or dependency.
Radiation: Positron emission tomography scan
Other: Magnetic resonance imaging



Primary Outcome Measures :
  1. Brain metabolic activity [ Time Frame: Baseline ]
    Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls

  2. Abnormalities in the fractional anisotropy [ Time Frame: Baseline ]
    Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls

  3. Behavioral performance measures on the executive functions [ Time Frame: Baseline ]
    Determine if the inhalant use disorder participants show neuropsychological impairments relative to healthy controls in attention and executive functions

  4. Severity inhalant use disorder [ Time Frame: Baseline ]

    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.


  5. Ratings and scores in the Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
    The proportion of participants that have good or bad sleep Quality.

  6. Age at which inhalants use began [ Time Frame: Baseline ]

    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.


  7. Duration of regular inhalant use [ Time Frame: Baseline ]

    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.



Biospecimen Retention:   Samples With DNA
cDNA obtained from reversal transcription of RNA isolated from periferical blood cells


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants in inhalant use disorder treatment program or Normal Control Subjects volunteers
Criteria

Inclusion Criteria:

  • Males between 18 to 40 years old.
  • Subjects must have a diagnosis of inhalant use disorder who are under a treatment program for addictive disorders or normal control without a history of drug abuse or dependency. Control participants must be matches with the inhalant use disorder participants according to age and years of education.
  • Subjects in both the inhalant use disorder and control groups will be volunteers who signed informed consent.

Exclusion Criteria:

  • Epilepsy or clinically relevant seizures in the last year
  • Cognitive impairment evaluated through Mini-Mental State Examination
  • Psychosis
  • Manic or hypomanic episode
  • Moderate or severe suicide risk
  • Panic disorder
  • Claustrophobia: Subjects will be questioned about their potential discomfort in being in an enclosed space, such as a PET or MRI scanner.
  • History of head trauma with loss of consciousness > 30 min.
  • Neurological surgical procedures
  • Diabetes
  • Positive test for hippuric acid
  • Current use of antipsychotic medication
  • Current illnesses, painful conditions or other disorders, which in the judgment of the investigators, might invalidate the scientific goals of the study or pose undesirable difficulties or risks for subjects
  • In the case for magnetic resonance imaging, Individuals who would be unable to undergo a MRI scan, for example, individuals who have metal clips in their body, metallic prostheses (i.e., replacement body parts, such as a hip joint), a pacemaker, or other pieces of metal in their body (shrapnel, metal filings, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188914


Locations
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Mexico
National Institute of Neurology and Neurosurgery Manuel Velasco Suarez
Mexico city, Mexico, 14269
Sponsors and Collaborators
Miguel Ángel Mendoza Meléndez
National Institute of Neurology and Neurosurgery, Mexico
Investigators
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Principal Investigator: Miguel Ángel Mendoza Meléndez, MD, MPH Institute for Attention and Prevention of Addictions in Mexico City
Principal Investigator: Nora Estela Kerik Rotenberg, MD National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.
Publications:
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Responsible Party: Miguel Ángel Mendoza Meléndez, Director of Research and Evaluation, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México
ClinicalTrials.gov Identifier: NCT02188914    
Other Study ID Numbers: 11/13 protocol
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Keywords provided by Miguel Ángel Mendoza Meléndez, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México:
Inhalant use disorder
Positron emission tomography
Magnetic Resonance Imaging
Executive functions assessment
Transcriptome
Additional relevant MeSH terms:
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Disease
Pathologic Processes