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Completed

NCT Number: NCT02249299

Experimental Medicine in ADHD - Cannabinoids

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London

London, SE5 8AF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Exclusion criteria will include autism spectrum disorders and other psychiatric disorders including recurrent major depression, bipolar I disorder, any psychotic disorder and obsessive compulsive disorder and learning difficulties defined as an IQ < 70. Neurological problems and known or suspected history of a drug or alcohol dependence disorder. Subjects who are using or have used cannabis or cannabis based medications in the 30 day period prior to study entry. Concurrent history of renal, hepatic, cardiovascular or convulsive disorders. Females who are pregnant or breastfeeding. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use two effective forms of contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (Note: a male condom should not be used in conjunction with a female condom).

Treatment and study plan

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).

Other names: Sativex

Placebo

Drug

Primary outcomes

  1. Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity'

    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

  1. ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability

    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.

  2. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Executive function measured with: The Brief-A.

  3. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Common psychopathology measured with: The Symptom Check-List (SCL-90)

  4. Self-report behavioural questionnaire

    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)

  5. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Mood measured with: The Affective Lability Scale (ALS-SF)

  6. Self-report behavioural questionnaires

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)

  7. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)

  8. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Control over thoughts: Cognitive Control Questionnaire

  9. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    The Brief COPE assesses how participants are coping with stressful life events

  10. Self-report behavioural questionnaire

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.

  11. Self-report behavioural questionnaires

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)

  12. Self-report behavioural questionnaires

    Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)

    The Adult ADHD Quality of Life Scales (AAQoL)

  13. Change in cognitive performance

    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

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • South London and Maudsley NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2014
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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