Clinical trial NCT02188914: Brain Imaging Studies of the Effect of Inhalant Use Disorder
Official title: Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inhalant Use Disorder
Keywords: Inhalant use disorder
Positron emission tomography
Magnetic Resonance Imaging
Executive functions assessment
Transcriptome
Lead sponsor: Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México
Sponsor class: OTHER_GOV
Collaborators: name: National Institute of Neurology and Neurosurgery, Mexico
First posted: 2014-07-14
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in inhalant use disorder treatment program or Normal Control Subjects volunteers

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


Eligibility criteria: 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.).

Primary outcomes:
measure: Brain metabolic activity
timeFrame: Baseline
measure: Abnormalities in the fractional anisotropy
timeFrame: Baseline
measure: Behavioral performance measures on the executive functions
timeFrame: Baseline
measure: Severity inhalant use disorder
timeFrame: Baseline
measure: Ratings and scores in the Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Age at which inhalants use began
timeFrame: Baseline
measure: Duration of regular inhalant use
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: National Institute of Neurology and Neurosurgery Manuel Velasco Suarez
Study officials:
affiliation: Institute for Attention and Prevention of Addictions in Mexico City
name: Miguel Ángel Mendoza Meléndez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.
name: Nora Estela Kerik Rotenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villatoro JA, Cruz SL, Ortiz A, Medina-Mora ME. Volatile substance misuse in Mexico: correlates and trends. Subst Use Misuse. 2011;46 Suppl 1:40-5. doi: 10.3109/10826084.2011.580205.
citation: Yucel M, Takagi M, Walterfang M, Lubman DI. Toluene misuse and long-term harms: a systematic review of the neuropsychological and neuroimaging literature. Neurosci Biobehav Rev. 2008 Jul;32(5):910-26. doi: 10.1016/j.neubiorev.2008.01.006. Epub 2008 Mar 27.
citation: Aydin K, Sencer S, Demir T, Ogel K, Tunaci A, Minareci O. Cranial MR findings in chronic toluene abuse by inhalation. AJNR Am J Neuroradiol. 2002 Aug;23(7):1173-9.
citation: Brouette T, Anton R. Clinical review of inhalants. Am J Addict. 2001 Winter;10(1):79-94. doi: 10.1080/105504901750160529.
citation: Takagi M, Lubman DI, Walterfang M, Barton S, Reutens D, Wood A, Yucel M. Corpus callosum size and shape alterations in adolescent inhalant users. Addict Biol. 2013 Sep;18(5):851-4. doi: 10.1111/j.1369-1600.2011.00364.x. Epub 2011 Sep 29.
citation: Yucel 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.
citation: Volkow ND, Fowler JS, Wang GJ. Positron emission tomography and single-photon emission computed tomography in substance abuse research. Semin Nucl Med. 2003 Apr;33(2):114-28. doi: 10.1053/snuc.2003.127300.