HOW DO WE SETUP FUTURE CLINICAL TRIALS USING CANNABIS?

As most of us are aware, many of the cannabis studies done in the US over the past 25 or more years, have been sponsored by federal organizations(NIDA), which generally only approved studies that were aimed to show a negative outcome from the use of cannabis. Despite this massive efforts, it is very clear to most Americans and most physicians, that cannabis does have some medical indications. No question of that.

So, how can we assure that cannabis gets a fair shot during standard randomized clinical trials? If someone were to even give us legal authority and full federal support to run a clinical trial, for example, on PTSD…..what forms of cannabis do we use? Do we use THC? CBD? BOTH? What about Terpenes? What about dosing??? What about route of administration? Frequency?

I know for certain that at this point in time, I do not know the answer to this question. I do treat every patient “by the mg” and give them very specific Treatment Plans, but it is for THAT patient. I am not sure what I would select for the SINGLE best for a group.

This is a critical issue, as if we are to have well designed trials and hope to give cannabis at least an even chance, we need to use what we BELIEVE to be the best type/dose/route/dose/frequency.

As I said, I don’t know the answer for the single best one, but as compared to two years ago I do know a few reasonable dosing schedules and am anxious to learn more with every patient.

So, our plan at GreenBridge is to use 1500 patients from a collective that only distributes dosed cannabis medicine. These patients know how much and how they take their cannabis. The Data is being slowly accumulated and studied. (All patient data is de-identified as per standard privacy laws).

I am optimistic that one year from now, we will have fairly reasonable recommendations. We are employing both Serum Cannabinoid Testing and Functional MRI to add valuable clinical data.

Any thoughts? Suggestions?

Author
Allan Frankel, MD Dr Allan Frankel is one of the few physicians in the US who truly understands Cannabis as a medicine. All treatments suggested have been well studied. Every patient seen by Dr Frankel is given a personally created Treatment Plan created with the patient's specific issues defined. Plant medicine requires "tuning" of the dosing. Dr Frankel works with his patients thru a messaging portal. The use of this portal, allows quick and simple follow up contact with Dr Frankel. Patients are not charged for these messages, as this is how Dr Frankel has learned what he has learned. Follow up appointments in person or by phone/video are also available when needed

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