Brain Imaging Studies of the Effect of Inhalant Use Disorder

Sponsor
Miguel Ángel Mendoza Meléndez (Other)
Overall Status
Completed
CT.gov ID
NCT02188914
Collaborator
National Institute of Neurology and Neurosurgery, Mexico (Other)
70
1
20.9
3.3

Study Details

Study Description

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 Phase
  • Radiation: Positron emission tomography scan
  • Other: Magnetic resonance imaging

Study Design

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 :
Nov 1, 2014
Actual Primary Completion Date :
Jul 30, 2016
Actual Study Completion Date :
Jul 30, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Brain metabolic activity [Baseline]

    Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls

  2. Abnormalities in the fractional anisotropy [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 [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 [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 [Baseline]

    The proportion of participants that have good or bad sleep Quality.

  6. Age at which inhalants use began [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.).

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Jul 14, 2014
Last Update Posted:
Aug 17, 2017
Last Verified:
Aug 1, 2017
Keywords provided by Miguel Ángel Mendoza Meléndez, Director of Research and Evaluation, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2017