Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Brain metabolic activity
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.).
结局指标
主要结局
Brain metabolic activity
时间窗: Baseline
Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls
Abnormalities in the fractional anisotropy
时间窗: Baseline
Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls
Behavioral performance measures on the executive functions
时间窗: Baseline
Determine if the inhalant use disorder participants show neuropsychological impairments relative to healthy controls in attention and executive functions
Severity inhalant use disorder
时间窗: 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
时间窗: Baseline
The proportion of participants that have good or bad sleep Quality.
Age at which inhalants use began
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Miguel Ángel Mendoza Meléndez
Director of Research and Evaluation
Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México