search
Back to results

Experimental Medicine in ADHD - Cannabinoids (EMA-C)

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sativex Oromucosal Spray
Placebo
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring ADHD,, Cannabis,, Sativex,, Endocannabinoid,, Cognition

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sativex Oromucosal Spray

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Self-report behavioural questionnaire
Executive function measured with: The Brief-A.
Self-report behavioural questionnaire
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Self-report behavioural questionnaire
Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)
Self-report behavioural questionnaire
Mood measured with: The Affective Lability Scale (ALS-SF)
Self-report behavioural questionnaires
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Self-report behavioural questionnaire
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Self-report behavioural questionnaire
Control over thoughts: Cognitive Control Questionnaire
Self-report behavioural questionnaire
The Brief COPE assesses how participants are coping with stressful life events
Self-report behavioural questionnaire
The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.
Self-report behavioural questionnaires
Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)
Self-report behavioural questionnaires
The Adult ADHD Quality of Life Scales (AAQoL)
Change in cognitive performance
SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention

Full Information

First Posted
September 3, 2014
Last Updated
December 3, 2020
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02249299
Brief Title
Experimental Medicine in ADHD - Cannabinoids
Acronym
EMA-C
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
ADHD,, Cannabis,, Sativex,, Endocannabinoid,, Cognition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sativex Oromucosal Spray
Arm Type
Active Comparator
Arm 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 Title
Placebo
Arm Type
Placebo Comparator
Arm 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(s)
Sativex Oromucosal Spray
Other Intervention Name(s)
Sativex
Intervention 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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity'
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.
Time Frame
6 weeks (baseline (day 1)-follow-up (day 42))
Secondary Outcome Measure Information:
Title
ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability
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.
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42))
Title
Self-report behavioural questionnaire
Description
Executive function measured with: The Brief-A.
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
Mood measured with: The Affective Lability Scale (ALS-SF)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaires
Description
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
Control over thoughts: Cognitive Control Questionnaire
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
The Brief COPE assesses how participants are coping with stressful life events
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaire
Description
The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaires
Description
Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Self-report behavioural questionnaires
Description
The Adult ADHD Quality of Life Scales (AAQoL)
Time Frame
6 weeks (baseline (day 1) - follow-up (day 42)
Title
Change in cognitive performance
Description
SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention
Time Frame
6 weeks (baseline (day 1)-follow-up (day 42))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Asherson, MD, PhD
Organizational Affiliation
Institute of Psychiatry, King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28576350
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.
Results Reference
result

Learn more about this trial

Experimental Medicine in ADHD - Cannabinoids

We'll reach out to this number within 24 hrs