EMA-C: Experimental Medicine in ADHD - Cannabinoids

Sponsor

King's College London (Other)

Overall Status

Completed

CT.gov ID

NCT02249299

Collaborator

South London and Maudsley NHS Foundation Trust (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder (ADHD)	Drug: Sativex Oromucosal Spray Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

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)

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Arm

Intervention/Treatment

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 Names:

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

Outcome Measures

Primary Outcome Measures

Change in performance on the QB Test using the average of 3 weighted indexes: 'activity' 'inattention' and 'impulsivity' [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 [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 [6 weeks (baseline (day 1) - follow-up (day 42)]
Executive function measured with: The Brief-A.
Self-report behavioural questionnaire [6 weeks (baseline (day 1) - follow-up (day 42)]
Common psychopathology measured with: The Symptom Check-List (SCL-90)
Self-report behavioural questionnaire [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 [6 weeks (baseline (day 1) - follow-up (day 42)]
Mood measured with: The Affective Lability Scale (ALS-SF)
Self-report behavioural questionnaires [6 weeks (baseline (day 1) - follow-up (day 42)]
Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)
Self-report behavioural questionnaire [6 weeks (baseline (day 1) - follow-up (day 42)]
Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)
Self-report behavioural questionnaire [6 weeks (baseline (day 1) - follow-up (day 42)]
Control over thoughts: Cognitive Control Questionnaire
Self-report behavioural questionnaire [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 [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 [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 [6 weeks (baseline (day 1) - follow-up (day 42)]
The Adult ADHD Quality of Life Scales (AAQoL)
Change in cognitive performance [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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).