Dr. Frankel's Journal

DR ALLAN FRANKEL’S EARLY VERSION INITIAL DOSAGE AND ADMINISTRATION GUIDE

March 14, 2014
Allan Frankel, MD

I. GENERAL:
The cannabis plant contains over 100 different cannabinoids around 150 terpenes and perhaps another 100 or so other Amide molecule and flavonoids. Precise dosing of these components, accompanied by comprehensive studies, is the only way we can move forward scientifically. This guide is our first attempt to describe our dosing and administration experience with cannabis medicine.
II. THE MOLECULES OF CANNABIS
CANNABINOIDS
The most well known cannabinoids are THC (Tetrahydocannabinol) and CBD (Cannabidiol). Additional cannabinoids such as THCV, CBC, and CBG are being studied internationally, which clearly demonstrate the huge clinical impact they are having. THC is the most psychoactive cannabinoid in the plant while CBD is non-psychoactive and even counteracts much of the psychoactive effect of THC. The actions of these two cannabinoids will be discussed below.
TERPENES
Terpenes are essentially small cannabinoid molecules that are found in nearly all plants we know. The terpenes and related flavonoids are the molecules that give cannabis it’s taste, scent and character. In addition, many terpene molecules are active at several central nervous system receptors, receptors throughout our bodies and contribute to many important clinical benefits we achieve from cannabis. We all generally get a good feeling from smelling a lemon. This is due to a terpene called limonene found in lemons and other citrus fruits and also present in cannabis. All the various cannabinoids, terpenes, flavonoids and other alkaloids combine to give us the effects we desire.

Forms and Delivery
The methods by which cannabinoids and their associated molecules are processed into a deliverable form of medicine are either through whole plant extraction or via molecular/synthetic means.
The primary delivery methods of such forms of cannabis medicine are:
• Inhaled
• Ingested
• Sublingual/Oral Bucal
• Topical (either systemic or dermal)
• Rectal
For the purposes of this guide, we will be presenting information on “whole plant extractions” and the dosing of whole plant extracted CBD and THC via the sublingual/oral buccal method.
The dosing of whole plant extracted CBD and THC is VERY different from the dosing of molecular/synthetic forms of cannabis medicine. As an example, for anxiety, as little as 2 mg of whole plant extracted CBD is quite effective, but in Europe there are numerous references to using hundreds of mg of molecular/synthetic CBD to achieve a similar result. So, when reading various doses, be certain to know what form of cannabis medicine is being referenced.

III. THE PSYCHOACTIVITY SCALE

A physician always explains to a patient the indications and effectiveness of a medicine and the side effects that may be associated with such medicine. With the dosing of cannabis medicine, the degree to which a patient may experience psychoactivity, or “stoniness”, is critical to convey to the patient. A ten point scale has evolved where a score or “PA” (Psychoactive) of 1 will have nearly zero psychoactivity, while a score of 10, means significant psychoactive effect.
Physicians should instruct patients to use the psychoactive number as a guide to how “altered” they will feel. As always, there are a number of individual-to-individual differences, but the general rules seem to be holding true. It is important to remember, that this is not a scale of “effectiveness” for any given illness or patient, but simply a measure of expected psychoactivity.

III. ADMINISTRATION OF EXTRACTS (PLEASE SEE PRODUCT SECTION BELOW FOR DETAILS OF EACH EXTRACT)
It is always encouraged to start with a single spray of extract. The first dose should always be taken when in a comfortable environment where driving will not be required. The patient should swallow FIRST, before administering the extract. This is to dry the mucosa and help the extract maximally absorb. The extract should be sprayed under the tongue and using your tongue, GENTLY spread the extract on the soft pink tissue in your mouth. Be CERTAIN to only do one or two “swipes” around your mouth. If too much saliva is generated the medicine will be diluted and then swallowed and much of the benefit lost. IF a second or third spray is indicated, wait one minute in between sprays. (Multiple light coats are better than one heavy coat)
MAXIMUM BENEFIT of sublingual dosage is 45 minutes. Do not eat or drink anything for 15 minutes after administering the sublingual dosage. Duration of action is up to 4-8 hours.
If more than six sprays is required twice daily or more, please consult with your physician to consider alternative ways of using the extracts.
With rich CBD extracts, increasing the dose is very safe and generally entirely free of side effects. With the rich THC extracts, EXERCISE CAUTION!! It is strongly advised to take a single spray and wait 90 minutes before taking a second spray.
It is possible and often desirable to mix the rich THC extract with the rich CBD extract, for example taking one of each sprays at a time. Make 1 spray changes every day or two as tolerated.

INITIAL DOSING RECOMMENDATIONS FOR VARIOUS DISORDERS

The dosing presented herein is to be considered only a rough INITIAL guide. Although a reasonable amount of clinical data supports this dosing, it is still based upon a small but growing body of experience, which now needs formal documentation. This section will be frequently updated, as more information is collected.

Anxiety/Insomnia/Panic Disorders

EXTRACTS SUGGESTED: #1, #2 and#3 are the most common extracts to be used in these disorders. There are however, as always, exceptions. A patient with very good THC tolerance can often tolerate a #5 or 1:1 CBD:THC very well and treat both their anxiety syndrome and pain with a single extract. For others, little THC is tolerated and for many, more THC at night and less during the day is often a good approach. For example, perhaps using a low psychoactive extract such as #1 or #2 during the day will rarely cause much psychoactivity. This same person might do better with some additional THC at night.
Generally 2 mg (1 spray) of a rich CBD extract taken every 8-12 hours as instructed above is sufficient. Most patients do fine with 4 – 8 mg every 24 hours, but it is fine to add one or two sprays or 2-4 mg as needed throughout the day. THC is generally poorly tolerated in patients with anxiety but there are MANY exceptions. Sometimes, in order to control anxiety or panic disorders, more THC is required than expected. In general, if a patient is started on a high ratio CBD extract and is not doing well as the dose is slowly increased, it is often required to add more mg of THC to the daily regimen.

Neuropathic Pain
EXTRACTS SUGGESTED: With neuropathic pain, often the individual differences and the patient’s tolerance for THC end up dictating the initial treatment plan. There are many patients in whom more THC than CBD works best, but in general, I would start with a very low PA Extract, such as #2. COMBINED WITH #7. The #2, as above, has very little THC and the #7 is all THC, at 15 mg/ml and 2 mg THC per spray. The #2 has 2 mg CBD per spray. So, the patients can titrate their own ratio. Then with their physician’s assistance, can switch over to a pre-mixed extract.
So, either a patient should obtain both the #2 and #7 and titrate as below, or decide with their physician, which extract to consider. Let’s discuss the former.
In the first option, it would be reasonable for a patient to INITIALLY consider taking a spray, or 2 mg of CBD, in the AM, afternoon and bedtime for up to one week and see where they are clinically. If they are doing much better, they should hold off on adding THC. If after one week, there is little improvement, it would be reasonable to add 2 mg of THC at bedtime and watch for a few days and then consider another dose of 1 spray at mid-day if tolerated. The physician should be contacted if limited improvement is noted.
In the second option, it is always prudent to contact your physician when there is any question of side effects or lack of efficacy.

Disc and Other Orthopedic Pain
If nerve irritation is the primary issue; follow recommendations under “Neuropathic” pain. However if the pain is primarily skeletal (back, hip, knees) it seems to be more individual than predictive. Nearly all of these patients do better with some added THC. This is a good example of how important it is to establish the patient’s known or likely THC sensitivity. If it cannot be established, then it is always prudent to begin with using more CBD for a week or two and then begin adding THC as required. I would start with a single spray AM, PM and bedtime and slowly add one spray every day to the TOTAL daily # of sprays. For example, if the patient was taking 1 spray three times daily and is not adequately medicated, I would add ONE spray to the bedtime dose, wait a day or two and add a second dose to the daily regimen, etc.

Neurodegenerative Disorders
With these disorders, in nearly every situation the dosing is very individual. As with pain disorders, it seems generally best to start with a rich CBD extract with very minimal THC. Slowly increase the dose of whole plant CBD until perhaps reaching 30 mg of total cannabinoids/24 hrs in divided doses sublingually throughout the day. THC is generally very important in these patients and it is best to slowly and comfortably increase the amount of THC in the patient’s extract until they have reached around 30-40 mg of combined cannabinoids in a day. The patient should be in contact with their physician while making these adjustments.
Schizophrenia
THIS MUST BE DONE UNDER THE DIRECT CARE OF BOTH THE PATIENT’S PSYCHIATRIST AND MEDICAL CANNABIS EXPERT!
This warning is not because using CBD is so dangerous even with schizophrenia. Treating schizophrenia is a sensitive area, although I believe the data is now overwhelming saying that CBD can be helpful in treating Schizophrenia. So, in this case, I would suggest that starting with a nearly all CBD-Rich extract plant is very important to do. I would not give more THC than an 8:1 ratio. So, a typical extract to begin slowly with is one that might have 15 mg of CBD/ml and less than 1 mg THC/ml. Slow and steady with direct physician supervision is critical.

Cancer

1. SYMPTOMS RELATED TO CANCER: Symptoms related to cancer and its treatment is plentiful and can mostly be managed by following the guide for pain or anxiety. For the nausea of chemotherapy, it is often difficult to know whether using more CBD or THC is better for an individual patient. Also, sometimes, THC can be better for appetite enhancement and CBD better for nausea. So, there are two reasonable approaches. Either use as much THC in a rich CBD extract that you think the patient can tolerate, OR use a #1 and #7 as. As is clear under “products”, the #1 is a virtually pure 2 mg CBD per spray and the #7 is 2 mg THC/ml. The patient can start with some CBD for even some hours and then as needed, add the benefit of THC with a far less chance of THC “agitation”. The patient can then easily figure out whether to switch to a “combined” extract with both CBD and THC or feels they are doing well dosing individually.
2. Now the tough one. We have all heard, and there is pretty convincing data that whole plant cannabis, and specifically both THC and CBD and many of the terpenes mentioned above, can help reduce cancer burden on a patient. Although we hear people speak about cures, we just don’t know and sadly, for sure not everyone is made better. On the other hand, most of us seeing cancer patients and helping them find the “right” cannabis dose, do see amazing results, including massive tumor shrinkage. It seems unlikely that one type of therapy will be responsible for curing all types of cancers in all people. Regardless, if it helps a patient’s symptoms at a lower dose, and raising the dose, without toxicity seems over time to have a beneficial effect on tumor management, it seems entirely reasonable to do so. Dosing suggestions in the “Simpson” camp, include taking 100’s of mg of THC daily. I find this excessive and often toxic, although there are in fact some pretty amazing results in some patients. There is no established dose for using Cannabis as adjuvant therapy for cancer. At the same time, if one is going to “give it a go”, there must be some suggestions for guidance from physicians. I tell my patients to take 30-40 mg of total cannabinoids per 24 hours. The type of cannabinoid medicine that appears reasonable is a 2:1 , CBD:THC extract.
This is a very low dose as compared to some, but with cannabis, often:

LESS IS MORE!!
Multiple Sclerosis

MS is one of the few diseases where a pharmaceutical company, GW Pharma in Britain, already makes an extract that is distributed in six countries. The extract used in this situation is a 1:1 extract.

One should consult http://sativex.com, and read their dosage and administration information. Doses as low as 10-15 mg of cannabinoids daily up to 60-80 mg daily may be required.

If a patient is THC tolerant, I would suggest using the #5, or 1:1 CBD:THC. I would begin with one spray, or 2 mg three times daily and increase one spray per 24 hours every several days.

Be sure to consult with your physician.

Fibromyalgia

Fibromyalgia is a frustrating disease to treat both for the physician and patient. It has clear sleeping and pain components. In addition, as with any chronic pain syndrome, there is always an element of depression.

In most cases, it appears that Fibromyalgia can be treated much like chronic orthopedic pain, as above. Although we have so, so much to learn, it SEEMS that these patients should be given a little more CBD in comparison to their chronic pain counterparts.

It is reasonable to start with something like a 10:1 extract dividing the total daily dose into 4 times of administration. I would suggest a schedule such as approximately 6AM, Noon, 6 PM, Bedtime.

If a patient comes in and says they are already using THC based cannabis with some success, you know that going with a 1:1 will be reasonable. If not, starting with a 2:1 would be reasonable.

It is important to make certain the patient sleeps well and focusing the cannabinoid dosing on this will likely greatly benefit the patient.

V. PRODUCTS

My personal view on products is that they:

1. Must contain whole plant medical cannabis plant extract

2. They must be cleanly and organically grown and extracted

3. They must be lab tested and certified for content and safety

4. They must be easy dosed by the milligram and not the gram

5. There needs to be a variety of extracts with some being nearly all whole plant CBD, other whole plant THC, other’s with even balance and as many in between these ratios to satisfy various psychoactive sensitivities as well as allowing both dosing with CBD and THC. Over time, identical cannabinoid ratios will be present in various plants and they will vary by their minor cannabinoid content.

Ideally, some for of “stoniness” scoring related to CBD:THC ratio seems to ideal in helping both physicians and patients understand and best receive the most appropriate medicine for them.