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| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sativex Oromucosal Spray | Active Comparator | Participants will titrate onto Sativex during the first two weeks of the study, carried out according to a standardised dosing schedule. After 2 weeks the clinician and participant will decide on the optimal dose for the remainder of the 4 week trial |
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| Placebo | Placebo Comparator | Participants will titrate onto the placebo during the first two weeks of the study, carried out according to a standardised dosing schedule. After 2 weeks the clinician and participant will decide on the optimal dose for the remainder of the 4 week trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sativex Oromucosal Spray | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity' | 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. | 6 weeks (baseline (day 1)-follow-up (day 42)) |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability | 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. | 6 weeks (baseline (day 1) - follow-up (day 42)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Asherson, MD, PhD | Institute of Psychiatry, King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London | London | SE5 8AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28576350 | Result | Cooper RE, Williams E, Seegobin S, Tye C, Kuntsi J, Asherson P. Cannabinoids in attention-deficit/hyperactivity disorder: A randomised-controlled trial. Eur Neuropsychopharmacol. 2017 Aug;27(8):795-808. doi: 10.1016/j.euroneuro.2017.05.005. Epub 2017 May 30. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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| Placebo | Drug |
|
| Self-report behavioural questionnaire |
Executive function measured with: The Brief-A. |
| 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | Common psychopathology measured with: The Symptom Check-List (SCL-90) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | Mood measured with: The Affective Lability Scale (ALS-SF) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaires | Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | Control over thoughts: Cognitive Control Questionnaire | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | The Brief COPE assesses how participants are coping with stressful life events | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaire | The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events. | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaires | Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Self-report behavioural questionnaires | The Adult ADHD Quality of Life Scales (AAQoL) | 6 weeks (baseline (day 1) - follow-up (day 42) |
| Change in cognitive performance | SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention | 6 weeks (baseline (day 1)-follow-up (day 42)) |
| D064419 | Chemically-Induced Disorders |