Tag Archives: Therapeutic Cannabinoid

DEA says Inhaled is Better

Today the DEA announced that they have a new FDA approved form of THC called Syndros.  Syndros is the result of work of Insys Therapeutics to create a new oral THC that has 5mg per ML of solution. – FEDERAL REGISTER LINK

In the DEA’s findings they are planning to schedule this as a Schedule II drug because.

Dronabinol is a generic name for the (-) delta-9-trans isomer of tetrahydrocannabinol (THC). THC is the primary psychoactive substance in marijuana. Dronabinol is the active pharmaceutical ingredient in Syndros. As stated by HHS, Marinol (synthetic dronabinol in sesame oil and encapsulated in a soft gelatin capsule) was approved by the FDA for medical use on May 31, 1985 and placed in schedule II based on its accepted medical use and high abuse potential. On July 2, 1999, Marinol was rescheduled from schedule II to schedule III because of the findings of the DEA that the difficulty of separating dronabinol from the sesame oil formulation and the delayed onset of behavioral effects due to oral route administration supported a lower abuse potential of Marinol as compared to substances in Schedule II. 64 FR 35928.

Going on to state:

HHS indicated that the formulation of Syndros (oral solution) is easier to abuse than Marinol because this liquid formulation can be manipulated to produce concentrated extracts of dronabinol for abuse by inhalation (smoking or vaping) or through other routes of administration. Because of the large amount of dronabinol in Syndros oral solution it has a greater potential for extraction than Marinol and thus has a greater abuse potential.

Based on the use of Cannabis by the general public DEA feels that this form of THC needs to be a Schedule II drug.

What you find when reading further down is that it appears DEA would rather people smoke it because of the onset of effects are easier to control.

Oral consumption of dronabinol, compared to inhaled THC, may result in psychoactive effects that are delayed and stronger with an increased risk of experiencing serious adverse events.

But then they quickly add:

When dronabinol (THC) is smoked, the drug rapidly reaches the brain and psychoactive effects are felt within minutes of inhalation, which allows the subject to control the dose more readily.

The DEA is full of contradictory things but this just about takes the cake.  Using a substance via oral methods pose issues that smoking or inhalation don’t and is better at controlling the dose.  However they are afraid that people will do just that.  Take this new drug and turn it into something they can control the dose better.

There is a time that this potential rule can be commented on, see the link at the top of the page to the federal register.

VA releases Medical Cannabis Report

If anyone has been watching the VA website they had a report about the medical use of Cannabis for Pain and PTSD.  The document has not been available for the public but through the power of the Freedom of Information Act we were able to get a copy.

This 124 page, well researched document is probably one of the most extensive looks at Cannabis done by a Government agency.  It not only looks at the use of Cannabis for Pain and PTSD but also looks at the harms of Cannabis use.

While they didn’t find much quality research on the medical use of Cannabis for Pain or PTSD they did find a lot of information.  The research they cite from all kinds of sources indicate that the lack of research is limiting their ability to make quality decisions on Cannabis for Medicine or Safety.

CONCLUSIONS

Although cannabis is increasingly available for medical and recreational use, there is very little methodologically rigorous evidence examining its effects in patients with chronic pain or PTSD. There is limited evidence that cannabis may be helpful in improving pain and spasticity in selected populations with MS, but there is insufficient evidence in other populations. There is insufficient evidence examining the effects of cannabis in PTSD populations. Cannabis is associated with an increased risk of short-term adverse effects, but data on its effects on long- term physical health vary; harms in older patients or those with multiple comorbidities have not been studied. Cannabis has been associated with short-term cognitive impairment and potentially serious mental health adverse effects such as psychotic symptoms, though the absolute risk and application specifically to chronic pain and PTSD populations are uncertain.

You can get the entire document here at this link – Benefits and harms of cannabis in chronic pain or post traumatic stree disorder

DEA/DOJ not the Problem

I’m sorry but the DEA/DOJ are not the problem with Cannabis legalization on a federal level or even Scheduling of Cannabis.  The real problem is with HHS, FDA, NIDA and other “Medical” organizations that continue to feed DEA/DOJ faulty information.

While I’m not going to say that the DEA doesn’t want to have Cannabis in Schedule I for ease of prosecution, they are not to blame for failed Petitions.  The problem is in the petition process.  First the DEA is required to ask the FDA, NIH for a recommendation.  Well they both ask NIDA to give them the information and everyone knows that NIDA is opposed to Cannabis.

NIDA provides FDA and NIH with information about Cannabis and all it’s “Hazards”.  Rather than do a real investigation like it’s own PubMed and other resources it barfs up NIDA information and gives it to the DEA.

DEA then takes that information and says sorry not going to change anything.

There is also the fact that the petitions in the past 6-7 years have been faulty in their filing and haven’t been really challenged in court.

HIA has offered DEA resistance and met with success.  ASA is currently suing the DEA for it’s compliance with the little known “INFORMATION QUALITY ACT”.  This requires agencies to provide Quality Information when they give it out.  Frankly NIH, NIDA and any other agency that has information opposing Cannabis should be challenged.

If your not following on social media NIH, FDA, and NIDA then you should be:

FDA https://www.facebook.com/FDA/

NIDA https://www.facebook.com/NIDANIH/

NIH https://www.facebook.com/nih.gov/

USDA https://www.facebook.com/USDA/

Cannabis Extract Opens New Door

Everyone is talking about how terrible it was of the DEA to create a number for Cannabis Extracts.  Well there is an upside to the situation.

All the attention is being made to the single mention of CBD being made a Schedule I substance.  Nothing is further from the truth, CBD is not a scheduled substance by the federal government.  NO Cannabinoid, with exception to THC, is a controlled substance according to the federal government.

What has been missed by everyone is the DEA’s statement about CBD extracted from the Cannabis Plant.  That they see no way for it to be extracted without extracting other Cannabinoids like THC which is a scheduled substance.   So there is no change in the stance of the DEA, there has actually been clarification that mixtures of CBD that contain THC and are extracted from the cannabis plants are extracts, those without are not.

What people have been missing is the opportunity to petition the DEA to De-schedule Extracts.  As extracts now have their own ID number they can be scheduled differently than Cannabis just as THC is scheduled differently.

The science is clear and evident that Extracts are by far safer than raw cannabis.  It’s easier to maintain dosage and test lots.  You can take a ton of cannabis and create and extract, test that batch for purity and level of cannabinoids and have a uniform product.  Unlike a plant which changes from plant to plant, even if cloned, extracts offer uniformity which is what the FDA likes.

Extracts make sense and it makes sense to De-schedule them or Re-schedule them into another schedule like THC has.

DEA and Marijuana Extract Means.. NOTHING

On Dec 14th the DEA announced a new drug code for “Marijuana Extract” and there has been a lot of furor over the decision.  For those that have read the CSA and understand the meaning of the definition of “Marijuana” it already meant:

The term “marihuana” means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Prior to this announcement everything other than THC, which already has it’s own drug code, all other Cannabinoids were classified under the Marijuana Code.  What this does is separate out for purposes of clerical and data collection a difference between raw Cannabis plant material and Extractions made from the plant.

NOTHING has changed, no substance scheduling has changed, no laws have been changed.

So what does it really mean?  What it really means is that now the extracts that researchers have been getting from the Mississippi Farm now have a separate code.  This allows the DEA, FDA, HHS, NIDA to track what kind of research is being done.  Is it whole plant or an extract that is being used.

Frankly it wouldn’t be a bad idea to put each cannabinoid it’s own drug code.  This could do two things.  First it would track what research is being done with what cannabinoids.  It could also lead to many more cannabinoids being put into different schedules like THC is in a different schedule.  One by one move the cannabinoids to other schedules and you less reason to keep the whole plant scheduled in schedule I

 

WHO – Systematic Review of Cannabis Safety

who-report-safeIn a report to the upcoming WHO conference another report has been issued about the safety of Cannabis and it’s use in medicine.

The report acknowledges thousands of years of historical use of cannabis for medical purposes.  Unfortunately due to the limited number of published scientific studies on the few conditions they studied they didn’t find definitive proof of cannabis efficacy in the treatment.

What they did find is that in all cases there weren’t adverse side effects like other medications.

In regards to adverse events, the included studies considered many adverse events, the majority of them were of low to moderate gravity. For the most serious adverse events (i.e. CNS side effects, depression and confusion) no differences were observed between cannabis and placebo. Incidence of general psychiatric disorders was higher in the cannabis groups but results came only from two small studies (92 participants). In addition, frequency of dissociation was higher in the cannabis groups, and no studies considered the development of abuse or dependence.

The report Titled “Systematic reviews on therapeutic efficacy and safety of Cannabis (including extracts and tinctures) for patients with multiple sclerosis, chronic neuropathic pain, dementia and Tourette syndrome, HIV/AIDS, and cancer receiving chemotherapy Laura Amato, Marina Davoli, Silvia Minozzi, Zuzana Mitrova, Elena Parmelli, Rosella Saulle, Simona Vecchi DEPARTMENT OF EPIDEMIOLOGY LAZIO REGION, ASL ROMA 1 – ROME, ITALY”

Can be found at the following link – LINK

or we have archived it here – systematic_reviews_on_therapeutic_efficacy_and_safety

Therapeutic Cannabinoid Research

WHO Pre-review Report Cannabis and Cannabis resin

With the upcoming meeting of the World Health Organization (WHO) Expert Committee on Drug Dependence Thirty-eight Meeting in Geneva, on 14 – 18 November 2016 many are calling for Cannabis to be an agenda item.

coverIn a pre-view Report “Cannabis and Cannabis Resin Pre-Review Report A document prepared for the World Health Organization” was prepared by H. Valerie Curran, Philip Wiffen, David J. Nutt, Willem Scholten.  In their report they give all the reasons why Cannabis should be more than an Update Item on the agenda.

In their report to the WHO they state in the preface:

In the eighty years since cannabis and cannabis resin were last reviewed by the Health Committee of the League of Nations in 1935, both the social context of cannabis use and the science of drug dependence have dramatically changed. Yet, cannabis and cannabis resin continue to remain under the strictest control regime possible under the Single Convention, without a valid scientific re-assessment of this decision. Cannabis and cannabis resin are listed in Schedule I and Schedule IV respectively, which means that both remain strictly prohibited worldwide.

then adding that the WHO is acting in a manner that appears to make continued prohibition illegitimate

The current scheduling of cannabis is in marked divergence with the Convention’s principle that scheduling of substances should be based on a scientific assessment by WHO. In the absence of a recent assessment, the continued prohibition of cannabis appears completely illegitimate even though it may be legal.

38ccdThey then proceed to ask the WHO to conduct a Scientific Review of cannabis and cannabis resin

A scientific review by the WHO, the only authoritative global body to make such an assessment, would greatly legitimize international policies and their national implementation. A scientific assessment of cannabis and cannabis resin appears most timely given the many debates that have emerged on this issue across the world in recent years.

In the fifty years since it’s inception the WHO has never conducted a scientific review of cannabis.  Despite it’s mandate to review the substance.

The scheduling under the Single Convention on Narcotic Drugs assumes a scientific justification. However, cannabis and cannabis resin have never been evaluated by WHO since it was mandated the review of psychoactive substances in 1948.

The purpose of the pre-review report is to clarify the position of the current state of use both medically and none medically.

The purpose of a Pre-review is to determine whether current information justifies a Critical Review. For evaluating substances in a Pre-review, the categories of information are identical to those used in Critical Reviews. At the stage of the Pre-review, the Expert Committee must decide whether the information justifies a Critical Review. If it finds that the data available may justify changing the scheduling of cannabis and/or cannabis resin, the Committee should recommend a Critical Review in its next Meeting.

The 53 page report, or 75 with cites, covers everything from adverse reactions, LD50 level, and pretty much everything you ever wanted to know about cannabis and how it works.  The report is remarkable in it’s completeness.

Conclusions Despite that the scheduling system of substances under the Single Convention on Narcotic Drugs is supposed to be based on scientific assessments, the WHO has never reviewed cannabis and cannabis resin. This means also that the Expert Committee continues to recommend that cannabis is not to be used medically despite growing evidence of considerable medical use world-wide, including the availability of a pharmaceutical preparation with a marketing authorization in multiple countries. Many countries are struggling with the impact of the prohibition of cannabis with its wide negative impact on societies (including through human rights violations) and on drug markets and drug use, including on the market of synthetic cannabinoids.

Committee recommendations are needed on the following topics:

1. Whether a Critical Review should be conducted for reviewing the current scheduling in Schedules I and IV. Each of the following reasons would justify a recommendation for a Critical Review: a. because WHO has never conducted a Critical Review, meaning that there is no scientific justification for the current scheduling; b. because the wide-spread medical use, including the use of preparations with a marketing authorization is in contradiction to listing in Schedule IV; c. because it is not clear whether the dependence-producing properties of cannabis and cannabis resin are between codeine and morphine (justification for Schedule I) or between dextropropoxyphene and codeine (justification for Schedule II) or below those of dextropropoxyphene (justification for not scheduling).

2. On the medical use of cannabis and its preparations (which can include revoking old recommendations by the Committee)

3. On the need of quality control on cannabis and cannabis products for medical and non-medical use.

Here is a link to the piece – LINK

Here is the report itself just in case it disappears from the net – whocannabisreport

Therapeutic Cannabinoid Research

PTSD Clinical Trials Recruiting

clinicalEugene Applebaum College of Pharmacy and Health Sciences is currently recruiting patients for a Therapeutic Cannabinoid Research program for treatment of PTSD.

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the development of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.
This study which has been waiting to start since Feb of 2014 is currently recruiting patients.  You can find more information on how you qualify, and who to contact at the following link.  This link takes you to ClinicalTrials.Gov a site not affiliated in any many with us.

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Therapeutic Cannabinoid Research

 

Does Cannabis Use Equal Abuse?

As we have searched through various databases about Cannabis a consistent theme has developed.  Use = Abuse when it comes to Cannabis.

This just doesn’t make any sense.  Just because something is used doesn’t mean it’s abused.  Unfortunately because of state and federal laws, Use = Abuse.  At least that is what it looks like when you look at NIDA and other cannabis studies on use.

It also appears in many law cases.  The accused is said to have a cannabis use disorder.  What is a Cannabis Use Disorder?  Meaning the person violated the state or federal law that Cannabis is a schedule substance and not legal to buy like you can alcohol or tobacco?

Dr. Damon concluded that defendant suffers from … mild cannabis use disorder in a controlled environment, and antisocial personality disorder.

apaAccording to the DSM 5th revision Cannabis Use Disorder is described as

Cannabis use disorder or cannabis dependence is defined in the fifth revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as the continued use of cannabis despite clinically significant impairment, ranging from mild to severe.

So Use Disorder, which sounds really bad, is actually not.   “continued use of cannabis despite clinically significant impairment”.  Not DESPITE clinically significant impairment.  So simply using Cannabis is all it takes to get this “Disorder”.  But if there is no impairment how can there be a disorder?  That remains to be understood.

Cannabis, Safe & Effective

There are a lot of studies that have been completed and many more that are awaiting start.  You can find studies on what cannabis at ClinicalTrial.Gov and search for Cannabis – Marijuana – Cannabinoids and other terms and come up with all kinds of results.

fedregWhere you can really find heads up is the Federal Register.  There you will find people that are applying to obtain licenses from the DEA to handle Cannabis (search for 7360 the DEA code for Marijuana).  When they apply under law there is a comment period where persons, organizations and companies can make comment on the application.  Most of the time there is no comment made and then the DEA decides if they are going to grant or not. However if there are comments made then the DEA incorporates these comments into their reply to the application when they grant or deny.

nih1Finally there is also PubMed where you can search all kinds of different things.  You will find information like this from  Medical Marijuana: Just the Beginning of a Long, Strange Trip? C.D. Ciccone, PT, PhD, FAPTA, Department of Physical Therapy, Ithaca College.

Although there is still a need for randomized controlled clinical trials, preliminary studies have suggested that medical marijuana and related cannabinoids may be beneficial in treating chronic pain, inflammation, spasticity, and other conditions seen commonly in physical therapist practice. Physical therapists should therefore be aware of the options that are available for patients considering medical marijuana, and be ready to provide information for these patients. Clinicians should also be aware that marijuana can produce untoward effects on cognition, coordination, balance, and cardiovascular and pulmonary function, and be vigilant for any problems that may arise if patients are using cannabinoids during physical rehabilitation.

So it’s clear from the information available that THC, Cannabidiol along with all of the other cannabinoids and substances in Plant based Cannabis

  •  does not produce any unknown adverse effects or other effects that are extremely common in Pharmaceutical preparations.
  •  does not have an unattainable LD-50 level (another indicator of overall safety).
  • has shown therapeutic actions that are beneficial to many patients.

So there is no reason why companies should need to rely on synthetic versions of the various cannabinoid and plant compounds.  They should be allowed to use the whole plant and the various strains of the plant to treat any condition.

Given the safety of the substances, the variety of administration methods there is no reason not to use trial and error.  As has been seen with Charlotte’s Web there are strains that work better for some conditions.  As the science of cannabis expands so will the introduction of strain specific treatments.  There isn’t a reason to not be able to move from one concentration of substances to another just like doctors change medications that aren’t producing the desired results to ones that do work.

Not every medication works for every person.  It happens all the time in medicine, a doctor prescribes something and it just doesn’t work or produce the desired effect.  Change drugs to something similar and bingo it works.  Doctors can’t explain it, Pharmacy companies can’t explain it, the FDA can’t explain it.  Given the great number of varieties already developed and those that will be developed that lots of conditions can be treated with cannabis.

Cannabis has a long history of being safe and effective.  There is no reason that all cannabis can’t be used by patients because of this safety when used.  Unlike other medications that can produce irreversible affects, cannabis just doesn’t do that to patients.