Attention Deficit Hyperactivity Disorder (ADHD)EMA-CNCT02249299
Experimental Medicine in ADHD - Cannabinoids
A study testing Sativex Oromucosal Spray in people with Attention Deficit Hyperactivity Disorder (ADHD), run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Sativex Oromucosal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London
London, SE5 8AF
About this study
Official 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)
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.
- Being tested
- Sativex Oromucosal Spray, Placebo
- Keywords
- ADHD,, Cannabis,, Sativex,, Endocannabinoid,, Cognition
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sativex Oromucosal SprayDrug
Also called Sativex
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).
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sativex Oromucosal Spray |
| 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks (baseline (day 1)-follow-up (day 42))
Secondary outcomes (13)
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.
Measured: 6 weeks (baseline (day 1) - follow-up (day 42))
Self-report behavioural questionnaire
Executive function measured with: The Brief-A.
Measured: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Measured: 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)
Measured: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Mood measured with: The Affective Lability Scale (ALS-SF)
Measured: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaires
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Measured: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Measured: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Control over thoughts: Cognitive Control Questionnaire
Measured: 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
Measured: 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.
Measured: 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)
Measured: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaires
The Adult ADHD Quality of Life Scales (AAQoL)
Measured: 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
Measured: 6 weeks (baseline (day 1)-follow-up (day 42))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Philip Asherson, MD, PhD, Principal investigator, Institute of Psychiatry, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249299
- Sponsor's protocol ID
- EMA-C
- Acronym
- EMA-C
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2014
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28576350
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02249299
- Acronym / sponsor ID
- EMA-C / EMA-C
- Keywords
- ADHD,, Cannabis,, Sativex,, Endocannabinoid,, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sativex Oromucosal Spray | Active comparator | Drug: Sativex Oromucosal SprayParticipants 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 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sativex Oromucosal SprayAlso: SativexSativex 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). | Drug | Sativex Oromucosal Spray |
| Placebo | Drug | Placebo |
Primary outcome
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.
13 secondary outcomes
ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42))
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaires
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaire
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaires
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Self-report behavioural questionnaires
Time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
Change in cognitive performance
Time frame: 6 weeks (baseline (day 1)-follow-up (day 42))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Results publication: PubMed 28576350Cooper 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Asherson, MD, PhD principal investigator
Institute of Psychiatry, King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sativex Oromucosal Spray in people with Attention Deficit Hyperactivity Disorder (ADHD), run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.