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Experimental Medicine in ADHD - Cannabinoids (EMA-C)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by King's College London.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02249299
First Posted: September 25, 2014
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD) Drug: Sativex Oromucosal Spray Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ]
    Executive function measured with: The Brief-A.

  • 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)

  • 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)

  • Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ]
    Mood measured with: The Affective Lability Scale (ALS-SF)

  • Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ]
    Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)

  • Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ]
    Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)

  • Self-report behavioural questionnaire [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ]
    Control over thoughts: Cognitive Control Questionnaire

  • 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

  • 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.

  • 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)

  • Self-report behavioural questionnaires [ Time Frame: 6 weeks (baseline (day 1) - follow-up (day 42) ]
    The Adult ADHD Quality of Life Scales (AAQoL)

  • 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


Estimated Enrollment: 30
Study Start Date: August 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sativex Oromucosal Spray
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
Drug: 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).
Other Name: Sativex
Placebo Comparator: Placebo
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
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249299


Contacts
Contact: Emma Williams 02078485367/ 07718669535 emma.2.williams@kcl.ac.uk
Contact: Ruth E Cooper, Msc 02078485401/ 07891173986 ruth.cooper@kcl.ac.uk

Locations
United Kingdom
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London Recruiting
London, United Kingdom, SE5 8AF
Contact: Emma Williams    02078485367/ 07718669535    emma.2.williams@kcl.ac.uk   
Contact: Ruth Cooper, Msc    02078485401/ 07891173986    ruth.cooper@kcl.ac.uk   
Principal Investigator: Philip Asherson, MD, PhD         
Sub-Investigator: Ruth Cooper, Msc         
Sub-Investigator: Emma Williams         
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
Principal Investigator: Philip Asherson, MD, PhD Institute of Psychiatry, King's College London
  More Information

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02249299     History of Changes
Other Study ID Numbers: EMA-C
First Submitted: September 3, 2014
First Posted: September 25, 2014
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by King's College London:
ADHD,
Cannabis,
Sativex,
Endocannabinoid,
Cognition

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms