Sativex Oromucosal Spray
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).
SativexLoading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2020-12-04
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This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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).
SativexEligibility
primary outcomes
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.
secondary outcomes
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
Publications
No exact PMID-linked public article is currently readable locally.