Inhalant Use Disorder Clinical Trial
Official title:
Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
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
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | July 30, 2016 |
| Est. primary completion date | July 30, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 40 Years |
| Eligibility |
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.). |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | National Institute of Neurology and Neurosurgery Manuel Velasco Suarez | Mexico city |
| Lead Sponsor | Collaborator |
|---|---|
| Miguel Ángel Mendoza Meléndez | National Institute of Neurology and Neurosurgery, Mexico |
Mexico,
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Yücel 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Brain metabolic activity | Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls | Baseline | |
| Primary | Abnormalities in the fractional anisotropy | Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls | Baseline | |
| Primary | Behavioral performance measures on the executive functions | Determine if the inhalant use disorder participants show neuropsychological impairments relative to healthy controls in attention and executive functions | Baseline | |
| Primary | Severity inhalant use disorder | 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. |
Baseline | |
| Primary | Ratings and scores in the Pittsburgh Sleep Quality Index | The proportion of participants that have good or bad sleep Quality. | Baseline | |
| Primary | Age at which inhalants use began | 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. |
Baseline | |
| Primary | Duration of regular inhalant use | 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. |
Baseline |