Inhalant Use DisorderNCT02188914
Brain Imaging Studies of the Effect of Inhalant Use Disorder
An observational study of Inhalant Use Disorder, run by Miguel Ángel Mendoza Meléndez at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inhalant Use Disorder
- What is being tested?
- Positron emission tomography scan and Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2014to 30 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Participants in inhalant use disorder treatment program or Normal Control Subjects volunteers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.).
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Neurology and Neurosurgery Manuel Velasco Suarez
Mexico City, 14269
About this study
Official title: Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
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
- Conditions
- Inhalant Use Disorder
- Being tested
- Positron emission tomography scan, Magnetic resonance imaging
- Keywords
- Inhalant use disorder, Positron emission tomography, Magnetic Resonance Imaging, Executive functions assessment, Transcriptome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography scanRadiation
Magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Positron emission tomography scan; Other: Magnetic resonance imaging | |
| Normal control group | Normal control without a history of drug abuse or dependency. Receives: Radiation: Positron emission tomography scan; Other: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain metabolic activity
Determine if the inhalant use disorder participants have different brain metabolic activity than healthy controls
Measured: Baseline
Abnormalities in the fractional anisotropy
Determine if the inhalant use disorder participants show abnormalities in the fractional anisotropy than healthy controls
Measured: Baseline
Behavioral performance measures on the executive functions
Determine if the inhalant use disorder participants show neuropsychological impairments relative to healthy controls in attention and executive functions
Measured: Baseline
Severity inhalant use disorder
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.
Measured: Baseline
Ratings and scores in the Pittsburgh Sleep Quality Index
The proportion of participants that have good or bad sleep Quality.
Measured: Baseline
Age at which inhalants use began
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.
Measured: Baseline
Duration of regular inhalant use
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study start1 Nov 2014
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inhalant Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel Ángel Mendoza Meléndez
- Sponsor type
- Other government
- Collaborators
- National Institute of Neurology and Neurosurgery, Mexico
- Responsible party
- Sponsor-investigator, Miguel Ángel Mendoza Meléndez, Instituto para la Atención y Prevención de las Adicciones en la Ciudad de México
- Investigators
- Miguel Ángel Mendoza Meléndez, MD, MPH, Principal investigator, Institute for Attention and Prevention of Addictions in Mexico CityNora Estela Kerik Rotenberg, MD, Principal investigator, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188914
- Sponsor's protocol ID
- 11/13 protocol
- Status last verified
- Aug 2017
- First submitted
- 9 Jul 2014
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21609144Yucel 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.
PubMed 18456329Aydin 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.
PubMed 12169477Brouette T, Anton R. Clinical review of inhalants. Am J Addict. 2001 Winter;10(1):79-94. doi: 10.1080/105504901750160529.
PubMed 11268830Takagi 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.
PubMed 21955104Yucel 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.
PubMed 20731960Volkow 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.
PubMed 12756644
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiología Del Consumo de Substancias Psicoactivas: PET-CT- Inhalables
- ClinicalTrials.gov ID
- NCT02188914
- Acronym / sponsor ID
- 11/13 protocol
- Conditions
- Inhalant Use Disorder
- Keywords
- Inhalant use disorder, Positron emission tomography, Magnetic Resonance Imaging, Executive functions assessment, Transcriptome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Miguel Ángel Mendoza MeléndezOther government
- Collaborators
- National Institute of Neurology and Neurosurgery, Mexico
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalant use disorder group | – | Radiation: Positron emission tomography scan, Other: Magnetic resonance imagingSubjects must have a diagnosis of inhalant use disorder, according to the DSM-5, who are under a treatment program for addictive disorders. |
| Normal control group | – | Radiation: Positron emission tomography scan, Other: Magnetic resonance imagingNormal control without a history of drug abuse or dependency. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants in inhalant use disorder treatment program or Normal Control Subjects volunteers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography scan | Radiation | Inhalant use disorder group, Normal control group |
| Magnetic resonance imaging | Other | Inhalant use disorder group, Normal control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Background: PubMed 21609144Villatoro 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.
- Background: PubMed 18456329Yucel 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.
- Background: PubMed 12169477Aydin 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.
- Background: PubMed 11268830Brouette T, Anton R. Clinical review of inhalants. Am J Addict. 2001 Winter;10(1):79-94. doi: 10.1080/105504901750160529.
- Background: PubMed 21955104Takagi 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.
- Background: PubMed 20731960Yucel 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.
- Background: PubMed 12756644Volkow 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Ángel Mendoza Meléndez, MD, MPH principal investigator
Institute for Attention and Prevention of Addictions in Mexico City
Nora Estela Kerik Rotenberg, MD principal investigator
National Institute of Neurology and Neurosurgery Manuel Velasco Suárez.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inhalant Use Disorder, run by Miguel Ángel Mendoza Meléndez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain metabolic activity (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188914, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.