Status:
COMPLETED
Experimental Medicine in ADHD - Cannabinoids
Lead Sponsor:
King's College London
Collaborating Sponsors:
South London and Maudsley NHS Foundation Trust
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
18-55 years
Phase:
NA
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 st...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02249299
Start Date
August 1 2014
End Date
December 1 2015
Last Update
December 4 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, King's College London
London, United Kingdom, SE5 8AF