WHAT IS THE PROPOSED CLINICAL PROTOCOL?
The clinical protocol for this project will be based on the European Medicines Agency's guideline on the clinical investigation of medicinal products for the treatment of ADHD.
The study intends to provide evidence of a statistically significant correlation between the use of several strains of cannabis and a reduction in symptoms of inattention, impulsivity and hyperactivity for sufferers of ADHD in comparison with placebo, and possibly also other active comparators (e.g., Methylphenidate and Dexamphetamine).
The study will also measure real-world outcomes such as changes (good or bad) in focusing on tasks and academic performance, and improvements in associated behavioural and relational issues.
The initial clinical study will primarily focus on vaporized cannabis becuse inhalation is the method of administration preffered by most current users and the final pulmonary
uptake of THC from vaporization is almost identical to that from smoked cannabis.
However, anecdotal evidence suggests that many patients who have access to a range of various different cannabis products choose to consume edible products to achieve a long-lasting underlying level of medication to treat chronic symptoms, and for faster relief of acute symptoms use a trans-mucosal tincture, and/or inhale cannabinoids for immediate relief.
Further studies should therefore determine optimal dosages of these various non-smoked methods of administration including oral ingestion, trans-mucosal, vaporization and combinations of these methods to determine which medication regimes provide ADHD patients with the most effective relief of symptoms and facilitates the highest degree of functional improvements.
The initial study will most likely focus solely on adults. If permission could be obtained to simultaneously test adolescents or even children that would accelerate the process of getting this medicine to young patients in need, however that is currently unlikely to be approved during the ethical review process.
Encouraging results from the study of adults could then be used to help justify the need for studies of cannabis to treat ADHD in adolescents and children through the same clinical protocol used for the adult trials (though using age-group specific rating scales where appropriate), so that the data can be analysed both as separate groups and together as a whole.
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