Completed

NCT Number: NCT02188914

Brain Imaging Studies of the Effect of Inhalant Use Disorder

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

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Key information

Conditions

Inhalant Use Disorder

Age range

18 year–40 year

Sex eligibility

Male

Study type

Observational

Primary location

National Institute of Neurology and Neurosurgery Manuel Velasco Suarez

Mexico City, 14269, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Positron emission tomography scan

Radiation

Magnetic Resonance Imaging

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Miguel Ángel Mendoza Meléndez

Other Gov

Collaborators

National Institute of Neurology and Neurosurgery, Mexico

Registry information

Official study title

Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jul 14, 2014
Registry last updated: Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.