Cannabis Clinicians Colorado

Presents:

Cannabidiol as a Supplement

In Retired Professional Athletes

 

Cannabis Clinicians Colorado and Trust Pro Advocates, a non-profit referral network for retired elite athletes seeking medical guidance and support, have teamed up for an observational pilot research program on quality of life in retired professional athletes and cannabidiol  aka CBD. CBD is a non-psychoactive cannabidiol derived from either hemp or hops.  The study is focused on athletes who have played collision sports such as hockey or football professionally or at an elite level, such as ranked college teams, national teams, or Olympic teams.

Cannabis is already patented by the US Government as a neuroprotectant under USPTO Patent 6630507, and use of even small amounts of CBD are known to register as increased voltages on common brain scans.  The following link shows before and after WAVI scan results of an 8mg micro-dose of sublingual CBD administered to a 53 year old control subject.  (When queried about participation in competitive sports she asked “Does Scrabble count?”  No.  It doesn’t.)  WAVI-Report-Control-CBDMicroDose-12017

In October of 2017, Pat Karns, MA ATC of trustproadvocates.com traveled to Israel to discuss the pilot study with our friends Professor Raphael Mechoulam PhD and Inbal Sikorin RN.  Here are Pat Karns and Dr Mechoulam last fall.

Pat has worked extensively with Olympic and Professional athletes for over 30 years, including time as the Head Athletic Trainer for the Colorado Avalanche Hockey Team during their two Stanley Cup wins; the Minnesota NBA;  and Olympic sports, including soccer, luge and ice hockey. Dr Mechoulam is, of course, the world’s foremost cannabis researcher, having first discovered THC in the 1960’s, elucidating the chemical structure of this and many other cannabinoids, as well as discovering the endocannabinoid system in the body.

After discussing the nature, types, and severity of chronic medical issues frequently seen in retired athletes, Dr Mechoulam recommended three set doses of CBD for use in the pilot research program.  Athletes will be assigned the doses randomly, or a placebo.

Pat then met with our Medical Director for the study, former Buffalo Bills running back Herve Damas MD

After a bunch of meetings and testing with the WAVi, our team came up with a protocol.

An abbreviated version of the draft protocol is below.

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Are you an athlete retired from play?  Do you live in or near Denver, Colorado or Miami, Florida?

Email Rebecca@mjformds.com if you are interested in participating. You will need to visit either Pat or Herve in Denver or Miami 6 times.

Registration will begin only after IRB approval.

Are you a CBD manufacturer?  Want to donate products to this study?  Contact Martha at info@mjformds.com for donation rules

Protocol is subject to change until finalized and approved by our IRB.

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Supplemental Cannabidiol (CBD) and Quality of Life In Retired Professional Athletes

Observational Pilot Research 

DRAFT PROTOCOL SUBJECT TO CHANGES BY IRB

Study Overview:  A placebo controlled study of cannabidiol (CBD) as a supplement to current therapies in retired elite level athletes. We plan to give a 60-day supply of either a measured-dose daily CBD supplement or a placebo to athletes with medical issues resulting from their competitive years. Athletes will undergo monitoring by WAVi EEG scan measurements, and Quality of Life assessment surveys including pain scores, sleep scores, and neuro-cognition tests during the study.

Time-frame:   This is a 3-month study, planned to start pending IRB approval

Number of subjects:  24

Research Goal: Look for evidence of correlation or lack thereof between a given dose of CBD as a supplement to other treatments and improvement in quality of life in retired elite athletes.

Prerequisites: Participants must be 21 years of age and not pregnant. Study subjects must have participated in either professional sports or professional-level amateur sports (such as Olympic, elite college, or national teams) for at least 1 year and one or more have medical issues resulting from this participation. Collision sports such as football and hockey will be given preference. This is an uncontrolled pilot study, so subjects are advised to continue other medications, treatments, and therapies as needed during the study, with the exception of other types of medical and or recreational marijuana.

Methodology: 1. Study subjects will be interviewed by a medical professional or professional athletic trainer (know herein as the Clinician). A health history and athletic participation history will be taken. Quality of Life questions, including scores for pain, anxiety, depression, self-care and mobility, will be asked. Use of other therapies, treatments and drugs will be recorded.

2. Testing – WAVi EEG scans by clinicians in local areas closest to participants. This is a non-invasive, quick electroencephalogram.  It uses a snug hat with electrodes on it to measure electrical activity across the head.

3.  Neuropsychology testing: questionnaires measuring physical pain, sleep quality, functional abilities, depression, and anxiety. Scores are normed against a community population sample and a chronic pain patient sample. Pittsburgh Sleep Quality Index and cognition testing using the Roberto or RC21X app highlighting attention, processing speed, verbal and nonverbal memory, and executive functioning.

4. Subjects are given a 2-week supply of either a high-quality, commercially available CBD product or a placebo. Subjects will be given instructions for self-administering a set dose of cannabidiol once or twice daily. All labels will be standardized so neither the participant nor the Clinician knows if it’s a placebo or not.

5.  Subjects follow-up with the Clinician every two weeks. Again, WAVi EEG, Roberto cognition test, and Quality of Life questions, including scores for pain, anxiety, depression, self-care and sleep quality, will be asked. Use of other therapies, treatments and drugs will be recorded. Subjects reporting adverse events or side-effects, such as drowsiness, may have dosages dropped or changed to a single dose at bedtime. Subjects reporting no effect or a positive enough effect may have dosage increased per schedule.

6.  Product phase ends after 8 weeks.  Subjects stop using study supplements for next 4 weeks.

7. Discharge visit at 12 week mark repeats WAVi EEG and Quality of Life, cognition and nueropsych surveys to see if any effects have lasted past active supplementation.  All participants receive gift cards.

8. Data analysis begins.

 

Follow-up:  Subjects will receive follow-up care for any adverse events for an additional 30 days.