Sarah Fischer, PharmD Fellow in the University of Colorado Anscutz Medical Campus, presents “Acute Administration of Cannabis vs Oxycodone for Pain: Research Update,” at the Perspectives in Cannabis Research and Education event at CU Boulder, 3 November 2018. CORE Network organized the event (
Hi everyone thank you for the very kind introduction my name is sarah fisher i am a clinical neurology research fellow and one of the dispensing pharmacists for this trial and dr. linley is also here in the audience and she is our pi so hopefully she’ll help me answer some of these questions that i know you guys will have so we wanted to give a little update on the
Research that we have it’s not quite complete very preliminary but we’re excited i know you guys are excited so we wanted to share kind of what we have with you so far so just to start i wanted to give a little bit of a reminder and background information just to make sure that everyone’s on the same page before we kind of get into some of the preliminary data so
To start we are sed phe funded study we are randomized control trial and double-blind we have two cohorts of subjects the first one are our chronic back and neck pain patients which i may refer to as our spine patient group and then we also have a cohort of healthy controls and the reason that we wanted to include these healthy controls is just due to the complex
Nature of doing research in the spine pain patients a lot of them have comorbidities or maybe have developed a tolerance to opioid pain medications our study drugs that we have we have the vaporized cannabis product and this is in terms of the research literature medium dose so we get it tested by nida every six months and it’s come back about four and a half to
Five point four percent of thc and we allow for a flexible dosing scheme so when our patients come in they have the option of four to eight puffs inhaling that many and this is to allow the patients to self titrate to achieve kind of the desired effect that they want while balancing some of those potential side effects that we are monitoring for we also have our
Oxycodone immediate release capsules this is either five milligrams or milligrams and this dosing depends on which cohort they’re in as well as how much long acting opioid they are currently taking outside of this study we have our vaporize posse boa cannabis which was alluded to in the last study and our the last talk sees me and this is um the plant material that
Has had that cannabinoids extracted via ethanol and then lastly our placebo can our placebo oxycodone capsules which looks identical to the active oxycodone capsules just to note we do acquire our cannabis products from nida since this is the only plant based material that can be used legally for research purposes so once our subjects past the initial screening
Visit they come in for three separate study visits one study they will get the vaporized cannabis product with a placebo capsule one visit they will get the placebo cannabis with an active oxycodone capsule and then one visit they will get two placebos so just to make it very clear that patients are never getting the two actives in the same visit it’s either one
Or the other or neither so for our primary study aims we’re really looking at the effect of our study drugs on kind of that relief of pain so with our spine patients looking at their relief of their chronic pain and then in our healthy controls we induce experimental pain during their study visit and so we’re kind of measuring the sensitivity to that experimental
Pain so this picture is of our computer-controlled pain al gamma tur and it was developed with some of our colleagues up here in boulder so really excited about that and so we opted to do the computerized version of this device versus the handheld one or the one that the study coordinator can use just to reduce that potential for human error so how it works is it
Puts a stimulus on the muscle kind of right next to the shin bone and it induces pressure and as you can see this patient has a little device in their hand which has a button on it and so once that stimulus switches from pressure to a feeling of pain then they press the button and we record what that pressure is moving on into some of our secondary study aims we’re
Kind of looking at the global impression in their changes in pain as well as some subjective reports of the drug so kind of how they’re feeling after they take it which we’ll get into some of these in a few slides we also do a some neural cognitive functioning tests as well as a field sobriety test and then of course always monitoring for those adverse events our
Enrollment to date rawa our research coordinator who’s also here has done a lot of work to do a lot of pre-screening phone calls she’s done over 400 so that’s amazing thank you and then you can kinda see the trickle down of which how many patients have passed that pre-screening phone call we’ve had 49 patients come to that initial screening visit with 45 passing
That initial screening visit and then to date we have come we have completed 25 patients that have done all three study visits with some more kind of along that process the other thing that i wanted to note on this slide is that we do have 13 withdrawals however those patients were patients that pass both the pre-screen and screening visits but decided not to move
Forward with the study visit so they didn’t receive any of the study drugs so just as one more note before i kind of show you the nuts and bolts of this this is very preliminary data we’re not powered for in interim analyses but we did want to run some descriptive statistics for you to kind of show what we’re starting to see and this is just in those patients that
Have completed all three visits so keep in mind that the healthy controls we have tene that have completed these visits and with the spine patients we have five so kind of a small cohort to fall from but we still wanted to show you guys anyways and then also just one more note myself dr. linley rob were all blinded so we’re going to present the data to you today
As treatments a b and c and here we go so the first graph that we wanted to share with you this is our spine patient cohort and this is looking at their pain scores so on the left hand side you can see there nrs scale for pain which is the numeric rating for scale so zero being no pain at all ten being the worst pain you can imagine and then on the bottom we ask
Them to do this rating for us baseline five minutes after administration and then one two and three hours post administration as well as you can see the treatments treatment b kind of plateaus the whole time treatment c actually goes up a little bit and then comes back down which is kind of interesting and then treatment a which is that red line looks like it
Dips down and then comes back up closer to that three hours so again this is the only five patients worth of data and it’s kind of the average between all of them so it will probably be more informational to look at between patient information and kind of see how they respond individually versus as an average which will do that at the end once we have all of our
Data moving on into our healthy control subjects so remember they’re having that experimental pain and we’re measuring that threshold so we broke this out into males and females since it’s been documented in the medical literature that there’s a difference in pain threshold between the genders so we wanted to reflect that here so on the left hand side we have the
Pain threshold of when the patient’s kind of hit that button of the stimulus switching from pressure to pain and then along the bottom is again that those time points during their visit so the top just to kind of give you an example that green line that kind of goes up so the higher the number means that they’re having less sensitivity to pain or more analgesic
Effect from the study drug so you know at baseline they could only tolerate the 60 and then three hours they could tolerate it it looks like i like 75 and same with females not as much of a difference again these are just averages and don’t take into account that kind of between subject variability next we do kind of wanted to show you some of the subjective drug
Effects with our healthy controls and this is the 100 millimeter visual analog scale for each effect we ask a series of questions here’s one example i feel any drug effect and then this blue line represents a continuum with the left hand side not at all the right hand side staying extremely and the patient’s mark with a vertical black line where they feel they fall
On this scale and so when we measure these we measure from the left hand side and we have a hundred millimeter ruler that we use so just kind of better quantifies this information so this first one i feel any drug effect at all again just orient you on the left hand side 0 to 100 correlates to that blue line where they fall 0 being not at all 100 being extremely so
You can see we have them broken out by drug a drug b and drug c it’s interesting to see that drug a right away at 5 minutes kind of shoots up and then tapers off drug b is pretty low throughout and then drug c isn’t quite as high post administration goes up a little bit and then comes back down the next question we have is i feel a good drug effect so the patient
Likes how they’re feeling after drug administration again with drug a kind of starting off at that sixty and then tapering down drug be only really gets up to about ten or so then comes back down and then a similar effect is seen with drug c still lower than drug a only at about twenty five goes up and then comes back down this one is interesting i feel high again
Drug a really shoots up its up at the 70 and then tapers off drug c does similar again not quite as high as drug a but still some effect that goes up and then wears off and then drug b is interesting i guess from this question alone i’m blinded i have no idea so this is just my opinion but i would venture to guess that drug b is placebo but it is interesting that
You know at five minutes they’re still feeling some effect i guess are they still marked that they’re feeling some effects so perhaps this is the patient trying to figure out if they are having an effect or not um but so it does diminish over time this question i feel impaired again drug am five minutes after is up at about forty and kind of tapers off so less than
Those feelings of feeling high but still more than drug b or drug see again drug c at five minutes is a little bit goes up a little bit and then comes back down and then this last one that we have is i feel sedated which this is also interesting we thought as well drug a and drug c both have effect starting at five minutes however they’re a lot closer together than
The other questions so we thought that was interesting they’re kind of at that twenty to thirty mark and kind of just you know go along that doesn’t drop off substantially like in the previous slides and then again drug b is just down at ten maybe a little bit but then tapers off so in conclusion again just remember that this is very preliminary data we don’t have
A whole lot of patience to draw from yet so we can’t draw those really robust conclusions but we did want to share some of our findings with you so far because we thought it was interesting and we’re excited we hope that you guys are excited as well and then one last thing we do need more participants so if you know of anyone especially those with any chronic back
Or neck pain any patients that you think would be good for our study we’re more than happy to screen them for you here’s our contact information at the bottom and with that we’ll take any questions
Transcribed from video
Sarah Fischer: Acute Administration of Cannabis vs Oxycodone for Pain By Marty Otañez
