Experimental Medicine in ADHD - Cannabinoids

NCT02249299 | Completed

• 1 other identifier: EMA-C
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD,; Cannabis,; Sativex,; Endocannabinoid,; Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• ADHD symptoms of inattention, hyperactivity-impulsivity and emotional lability

  6 weeks (baseline (day 1) - follow-up (day 42))

• Self-report behavioural questionnaire

  6 weeks (baseline (day 1) - follow-up (day 42)

• Self-report behavioural questionnaire

  6 weeks (baseline (day 1) - follow-up (day 42)

• Self-report behavioural questionnaire

  6 weeks (baseline (day 1) - follow-up (day 42)

• Self-report behavioural questionnaire

  6 weeks (baseline (day 1) - follow-up (day 42)

Study Arms (2)

Sativex Oromucosal Spray

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Sativex Oromucosal Spray DRUG

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).

Also known as: Sativex

Sativex Oromucosal Spray

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

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

London, SE5 8AF, United Kingdom

Location

Related 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 30.

  PMID: 28576350 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Philip Asherson, MD, PhD

  Institute of Psychiatry, King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 25, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 4, 2020

Record last verified: 2015-09

Locations

GB (1)