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The role of the endocannabinoid system in Attention-Deficit/Hyperactivity Disorder and symptoms: a pharmacological fMRI study

The role of the endocannabinoid system in Attention-Deficit/Hyperactivity Disorder and symptoms: a pharmacological fMRI study - THC phMRI in ADHD patients

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON35106
Enrollment
24
Registered
2010-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD Attention-Deficit/Hyperactivity Disorder

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Diagnosed with ADHD (DSM-IV criteria) * History of mild cannabis use for at least one year (less than once/wek and more than 4 times / year) * Right-handedness, assessed with the Edinburgh Handedness Inventory * Written informed consent of the participant

Exclusion criteria

Exclusion criteria: * Any clinical significant abnormality of any clinical laboratory test, except for the predetermined psychiatric disorder, i.e. ADHD, including urinary screening * Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (see par 8.3.1.) * history of alcohol and /or drug abuse (DSM-IV criteria) * Body Mass Index (B.M.I) 28 kg/m2 * any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug * use of any medication within three weeks prior to the start of the study, except for paracetamol and medication for ADHD and related symptoms * contra-indications for MRI (claustrophobia, metal objects in body (e.g. braces, pacemakers, metal clips)

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of the study is the Blood-Oxygenation-Level-Dependent (BOLD)-signal, measured with fMRI

Secondary

MeasureTime frame
Behavioral parameters (reaction time, accuracy) during performance of the tasks in the scanner and during performance of the neuropsychological tests. Melatonin levels in saliva Bloodplasma levels of THC and its main metabolites

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)