Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Keywords
ADHD,, Cannabis,, Sativex,, Endocannabinoid,, Cognition
Brief summary
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.
Interventions
DRUGSativex 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).
DRUGPlacebo
Sponsors
South London and Maudsley NHS Foundation Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* The study is open for both men and women aged 18-55 who meet DSM 5 criteria for ADHD (N= 30). Subjects will be either unmedicated or medicated with stimulant medication only and be willing to come of this medication for 1 week before and for the duration of the study. To ensure that this does not disadvantage patients we will only include those on stimulant medication who do not take medication on a regular basis and where short periods of medication are not thought by both the patient and psychiatrist to represent a clinical problem in the overall control of the symptoms and impairments. For example, by including patients who are considering a stimulant drug holiday, which is a common clinical procedure in ADHD. Subjects must not use other prescription and non-prescription medication or recreational drugs during the study.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity' | 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
| Measure | Time frame | Description |
|---|---|---|
| ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability | 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. |
| Self-report behavioural questionnaire | 6 weeks (baseline (day 1) - follow-up (day 42) | Executive function measured with: The Brief-A. |
| Self-report behavioural questionnaires | 6 weeks (baseline (day 1) - follow-up (day 42) | Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI) |
| Change in cognitive performance | 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 |
Countries
United Kingdom
Outcome results
None listed