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

Group/Cohort | Intervention/treatment |
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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.
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Radiation: Positron emission tomography scan Other: Magnetic resonance imaging |
Normal control group
Normal control without a history of drug abuse or dependency.
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Radiation: Positron emission tomography scan Other: Magnetic resonance imaging |
- Brain metabolic activity [ Time Frame: Baseline ]Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls
- Abnormalities in the fractional anisotropy [ Time Frame: Baseline ]Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls
- 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
- 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.
- Ratings and scores in the Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]The proportion of participants that have good or bad sleep Quality.
- 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.
- 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

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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 |
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.).

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
Mexico | |
National Institute of Neurology and Neurosurgery Manuel Velasco Suarez | |
Mexico city, Mexico, 14269 |
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. |
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 |
Inhalant use disorder Positron emission tomography Magnetic Resonance Imaging Executive functions assessment Transcriptome |
Disease Pathologic Processes |