Brain Imaging Studies of the Effect of Inhalant Use Disorder

• ClinicalTrials.gov Identifier: NCT02188914
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: August 17, 2017
• Sponsor: Miguel Ángel Mendoza Meléndez
• Collaborator: National Institute of Neurology and Neurosurgery, Mexico
• Information provided by (Responsible Party): Miguel Ángel Mendoza Meléndez, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México

Study Description

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

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

Study Design

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Radiation: Positron emission tomography scan; Other: Magnetic resonance imaging
Normal control group; Normal control without a history of drug abuse or dependency.	Radiation: Positron emission tomography scan; Other: Magnetic resonance imaging

Outcome Measures

Primary Outcome Measures :

1. Brain metabolic activity [ Time Frame: Baseline ]
   Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls
2. Abnormalities in the fractional anisotropy [ Time Frame: Baseline ]
   Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls
3. 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
4. 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.

5. Ratings and scores in the Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
   The proportion of participants that have good or bad sleep Quality.
6. 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.

7. 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

cDNA obtained from reversal transcription of RNA isolated from periferical blood cells

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Participants in inhalant use disorder treatment program or Normal Control Subjects volunteers

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.).

Contacts and Locations

Locations

Mexico

National Institute of Neurology and Neurosurgery Manuel Velasco Suarez

Mexico city, Mexico, 14269

Sponsors and Collaborators

Miguel Ángel Mendoza Meléndez

National Institute of Neurology and Neurosurgery, Mexico

Investigators

• 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.

More Information

Publications:

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.

Yücel 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. Review.

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.

Brouette T, Anton R. Clinical review of inhalants. Am J Addict. 2001 Winter;10(1):79-94. Review.

Takagi M, Lubman DI, Walterfang M, Barton S, Reutens D, Wood A, Yücel 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.

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.

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. Review.

• 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
• Last Update Posted: August 17, 2017
• Last Verified: August 2017

Keywords provided by Miguel Ángel Mendoza Meléndez, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México:

Inhalant use disorder; Positron emission tomography; Magnetic Resonance Imaging; Executive functions assessment; Transcriptome

Additional relevant MeSH terms:

Disease; Pathologic Processes