<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02249299</url>
  </required_header>
  <id_info>
    <org_study_id>EMA-C</org_study_id>
    <nct_id>NCT02249299</nct_id>
  </id_info>
  <brief_title>Experimental Medicine in ADHD - Cannabinoids</brief_title>
  <acronym>EMA-C</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South London and Maudsley NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adult patients with ADHD commonly report an improvement in behavioural symptoms when using&#xD;
      cannabis with some reporting a preference towards cannabis over their ADHD stimulant&#xD;
      medication. The EMA-C study aims to investigate the effects of a cannabis based medication,&#xD;
      Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.&#xD;
&#xD;
      This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will&#xD;
      take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance&#xD;
      of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before&#xD;
      and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in&#xD;
      improvements in behaviour and cognition above that of the placebo group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity'</measure>
    <time_frame>6 weeks (baseline (day 1)-follow-up (day 42))</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42))</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Executive function measured with: The Brief-A.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Common psychopathology measured with: The Symptom Check-List (SCL-90)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Mood measured with: The Affective Lability Scale (ALS-SF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaires</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Control over thoughts: Cognitive Control Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>The Brief COPE assesses how participants are coping with stressful life events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaire</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaires</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report behavioural questionnaires</measure>
    <time_frame>6 weeks (baseline (day 1) - follow-up (day 42)</time_frame>
    <description>The Adult ADHD Quality of Life Scales (AAQoL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive performance</measure>
    <time_frame>6 weeks (baseline (day 1)-follow-up (day 42))</time_frame>
    <description>SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>Sativex Oromucosal Spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sativex Oromucosal Spray</intervention_name>
    <description>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).</description>
    <arm_group_label>Sativex Oromucosal Spray</arm_group_label>
    <other_name>Sativex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study is open for both men and women aged 18-55 who meet DSM 5 criteria for ADHD&#xD;
             (N= 30). Subjects will be either unmedicated or medicated with stimulant medication&#xD;
             only and be willing to come of this medication for 1 week before and for the duration&#xD;
             of the study. To ensure that this does not disadvantage patients we will only include&#xD;
             those on stimulant medication who do not take medication on a regular basis and where&#xD;
             short periods of medication are not thought by both the patient and psychiatrist to&#xD;
             represent a clinical problem in the overall control of the symptoms and impairments.&#xD;
             For example, by including patients who are considering a &quot;stimulant drug holiday&quot;,&#xD;
             which is a common clinical procedure in ADHD. Subjects must not use other prescription&#xD;
             and non-prescription medication or recreational drugs during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will include autism spectrum disorders and other psychiatric&#xD;
             disorders including recurrent major depression, bipolar I disorder, any psychotic&#xD;
             disorder and obsessive compulsive disorder and learning difficulties defined as an IQ&#xD;
             &lt; 70. Neurological problems and known or suspected history of a drug or alcohol&#xD;
             dependence disorder. Subjects who are using or have used cannabis or cannabis based&#xD;
             medications in the 30 day period prior to study entry. Concurrent history of renal,&#xD;
             hepatic, cardiovascular or convulsive disorders. Females who are pregnant or&#xD;
             breastfeeding. Female subjects of child bearing potential and male subjects whose&#xD;
             partner is of child bearing potential, unless willing to ensure that they or their&#xD;
             partner use two effective forms of contraception, for example, oral contraception,&#xD;
             double barrier, intra-uterine device, during the study and for three months thereafter&#xD;
             (Note: a male condom should not be used in conjunction with a female condom).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Asherson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Psychiatry, King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London</name>
      <address>
        <city>London</city>
        <zip>SE5 8AF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>28576350</PMID>
  </results_reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD,</keyword>
  <keyword>Cannabis,</keyword>
  <keyword>Sativex,</keyword>
  <keyword>Endocannabinoid,</keyword>
  <keyword>Cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nabiximols</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02249299
org study id: EMA-C
nct id: NCT02249299
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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))
description: 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.
measure: ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability
time frame: 6 weeks (baseline (day 1) - follow-up (day 42))
description: 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.
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Executive function measured with: The Brief-A.
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Common psychopathology measured with: The Symptom Check-List (SCL-90)
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Mood measured with: The Affective Lability Scale (ALS-SF)
measure: Self-report behavioural questionnaires
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Control over thoughts: Cognitive Control Questionnaire
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: The Brief COPE assesses how participants are coping with stressful life events
measure: Self-report behavioural questionnaire
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.
measure: Self-report behavioural questionnaires
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)
measure: Self-report behavioural questionnaires
time frame: 6 weeks (baseline (day 1) - follow-up (day 42)
description: The Adult ADHD Quality of Life Scales (AAQoL)
measure: Change in cognitive performance
time frame: 6 weeks (baseline (day 1)-follow-up (day 42))
description: SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention
arm group label: Sativex Oromucosal Spray
arm group type: Active Comparator
description: 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
arm group label: Placebo
arm group type: Placebo Comparator
description: 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
intervention type: Drug
intervention name: Sativex Oromucosal Spray
description: 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).
arm group label: Sativex Oromucosal Spray
other name: Sativex
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Philip Asherson, MD, PhD
role: Principal Investigator
affiliation: Institute of Psychiatry, King's College London
facility: 
country: United Kingdom
citation: 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.
PMID: 28576350
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Nabiximols