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Experimental Medicine in ADHD - Cannabinoids (EMA-C)

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ClinicalTrials.gov Identifier: NCT02249299
Recruitment Status : Unknown
Verified September 2014 by King's College London.
Recruitment status was:  Recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date  ICMJE September 3, 2014
First Posted Date  ICMJE September 25, 2014
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Experimental Medicine in ADHD - Cannabinoids
Official Title  ICMJE 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)
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Attention Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE
  • 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
  • Drug: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: Sativex Oromucosal Spray
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02249299
Other Study ID Numbers  ICMJE EMA-C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE South London and Maudsley NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Philip Asherson, MD, PhD Institute of Psychiatry, King's College London
PRS Account King's College London
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP