Brain Imaging Studies of the Effect of Inhalant Use Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02188914
• Date of registration: 09/07/2014
• Prospective Registration: Yes
• Primary sponsor: Miguel Ángel Mendoza Meléndez
• Public title: Brain Imaging Studies of the Effect of Inhalant Use Disorder
• Scientific title: Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
• Date of first enrolment: November 1, 2014
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02188914
• Study type: Observational
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Miguel Ángel Mendoza Meléndez, MD, MPH
• Affiliation: Institute for Attention and Prevention of Addictions in Mexico City

• Name: Nora Estela Kerik Rotenberg, MD
• Affiliation: National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.

Key inclusion & exclusion 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.).



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Inhalant Use Disorder

Intervention(s)

Other: Magnetic resonance imaging

Radiation: Positron emission tomography scan

Primary Outcome(s)

Brain metabolic activity [Time Frame: Baseline]

Severity inhalant use disorder [Time Frame: Baseline]

Abnormalities in the fractional anisotropy [Time Frame: Baseline]

Ratings and scores in the Pittsburgh Sleep Quality Index [Time Frame: Baseline]

Age at which inhalants use began [Time Frame: Baseline]

Behavioral performance measures on the executive functions [Time Frame: Baseline]

Duration of regular inhalant use [Time Frame: Baseline]

Secondary ID(s)

11/13 protocol

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurology and Neurosurgery, Mexico