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 studies could provide evidence of a statistically significant correlation between the use of several different cannabinoid profiles and a significant reduction in symptoms of inattention, impulsivity and hyperactivity for sufferers of ADHD in comparison with placebo, Other active comparators (e.g., Methylphenidate and Dexamphetamine) may also be included.

As per the EMA guidelines, the studies 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.

it is likely that the initial clinical studies will focus on vaporized cannabis becuse inhalation by smoking is the method of administration preffered by most current users for ADHD, and the final pulmonary uptake of THC from vaporization is almost identical to that from smoked cannabis, without the potential dangers to patients' respiratory systems.

However, anecdotal evidence suggests that many patients who have access to a range of various different cannabis products often 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 in ADHD.

The initial study will most likely focus on adults, but if permission can also be obtained to simultaneously study adolescents and/or children that would accelerate the process of assessing the viability of these medicines for young patients.

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.

If permission can also be obtained to simultaneously study adolescents and/or children that would accelerate the process of assessing the viability of these medicines for young patients.

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