Experimental Medicine in ADHD - Cannabinoids

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249299
• Other study ID #: EMA-C
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

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).
• Placebo

Locations

Country	Name	City	State
United Kingdom	Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks (baseline (day 1)-follow-up (day 42))
Secondary	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.	6 weeks (baseline (day 1) - follow-up (day 42))
Secondary	Self-report behavioural questionnaire	Executive function measured with: The Brief-A.	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	Common psychopathology measured with: The Symptom Check-List (SCL-90)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	Mood will be measured using: The Centre for Neurologic Studies-Lability Scale (CNS-LS)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	Mood measured with: The Affective Lability Scale (ALS-SF)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaires	Sleep measured with: The Pittsburgh Sleep Quality Index (PSQI)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	Level of depressive thoughts: The Depressive Thoughts Questionnaire (DTQ)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	Control over thoughts: Cognitive Control Questionnaire	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	The Brief COPE assesses how participants are coping with stressful life events	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaire	The Brief Life Events Questionnaire (BLEQ) assesses the occurrence of stressful life events.	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaires	Functional Impairment: The Weiss Functional Impairment Rating Scale Self Report (WFIRS-S)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Self-report behavioural questionnaires	The Adult ADHD Quality of Life Scales (AAQoL)	6 weeks (baseline (day 1) - follow-up (day 42)
Secondary	Change in cognitive performance	SART: The SART is a computerised go/no go task measuring both response inhibition and sustained attention	6 weeks (baseline (day 1)-follow-up (day 42))