Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London
London, SE5 8AF, United Kingdom
NCT Number: NCT02249299
Adult patients with ADHD commonly report an improvement in behavioural symptoms when using cannabis with some reporting a preference towards cannabis over their ADHD stimulant medication. The EMA-C study aims to investigate the effects of a cannabis based medication, Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.
This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in improvements in behaviour and cognition above that of the placebo group.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
London, SE5 8AF, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sativex Oromucosal Spray (GW Pharma Ltd, Salisbury. UK). Each 100 microlitre spray contains: 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD).
Other names: Sativex
Time frame: 6 weeks (baseline (day 1)-follow-up (day 42))
QbTest: The Qb test is a computer administered attention test. An infrared camera monitors patient movement and measures activity; attention and impulsivity are calculated based on the task performance and activity level. The data is processed and compared with a normative group.
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42))
This will be assessed using the Conners' Adult ADHD Rating Scales (CAARS) and Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADS) combined (investigator rated): Both measure ADHD symptom severity.
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Executive function measured with: The Brief-A.
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Mood measured with: The Affective Lability Scale (ALS-SF)
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Control over thoughts: Cognitive Control Questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
The Brief COPE assesses how participants are coping with stressful life events
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
The Adult ADHD Quality of Life Scales (AAQoL)
Time frame: 6 weeks (baseline (day 1)-follow-up (day 42))
SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention
King's College London
Other
The Effects of Sativex on Neurocognitive and Behavioural Function in Adults With Attention-deficit/Hyperactivity Disorder; The EMA-C Study (Experimental Medicine in ADHD - Cannabinoids)
Acronym: EMA-C
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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