Marijuana and the Chronic Non-Cancer Pain Patient

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1 Marijuana and the Chronic Non-Cancer Pain Patient Kevin P. Hill, M.D., M.H.S. Pain 101: Provider Workshop 9/23/16 McLean Hospital Division of Alcohol and Drug Abuse Supported by NIDA K99/R00 DA (Kevin P. Hill, MD, MHS, PI).

2 Disclosures Grants from NIDA, Brain and Behavior Research Foundation, American Lung Association, Greater Boston Council on Alcoholism, Peter G. Dodge Foundation. Book- Hazelden Publishing

3 Three Areas of Focus Clinical work: McLean Substance Abuse consultation service, private practice, pro sports teams and leagues. Clinical research: 3 clinical trials (2 marijuana, 1 tobacco cigarettes). Educational outreach: Science vs. public perception, schools, policymakers.

4 In The Middle

5 Marijuana Use: Scope of the Problem

6 Context of Current Laws- National Statistics About 22 million Americans used marijuana in the past year, use doubled in past 10 years (Hasin et al. 2015). Powerful messages medical marijuana, legalization, entertainers/athletes. Some messages off the mark, contribute to gap between science and public perception.

7 Current Trends in Marijuana Use Compton, Lancet (2016)

8 Why So Complicated? Can t paint with a broad brush. Many misguided by their own experiences. Math can be tricky.

9 Marijuana Myths Not harmful Not addictive No withdrawal

10 IT IS HARMFUL! Early onset poor cognitive function, IQ decline (Pope 2003, Gruber 2011, Meier 2012) anxiety (Crippa 2009) depression (Degenhardt 2003) risk of psychosis (Kuepper 2011, Large 2011, Di Forti 2015)

11 IT IS ADDICTIVE! % of Basal Release % of Basal Release AMPHETAMINE hr MARIJUANA Drugs of abuse increase DA in the Nucleus Accumbens.triggers the neuroadaptions that result in addiction? % of Basal Release Tanda, et al, Science FOOD Empty Box Feeding Time (min) Di Chiara et al.

12 There is Withdrawal! (Vandrey et al., 2005; Vandrey et al. 2008, Budney et al., 2009) Symptom Severity Cannabis Tobacco 3 Mean Rating (0-3) Depress Sleep Diff Restless Craving* Irritable Sweat* Stomach Pain Nausea Shakiness Inc App* Headache Str Dreams Anger Aggress Diff Conc Dec App* Withdrawal Checklist Symptoms

13 Pharmacology of Marijuana 60+ pharmacologically-active cannabinoids. THC: euphoria, anti-inflammatory, psychosis. CBD: non-psychoactive, anti-anxiety, antipsychotic?

14 Potency Rising 60s, 70s, 80s: avg THC content 3-4%. Now: avg THC content 12% (ElSohly 2016). BUT you can get marijuana (plant not oil) in the 20s and low 30s.

15 Ideas vs. Implementation

16 2008- Decriminalization of less than an ounce in MA

17 2012 MMJ Ballot Initiative

18 Legalization in 2016?

19

20 State of the Science: Medical Marijuana

21

22 FDA-Approved Cannabinoids Dronabinol (Marinol)- oral THC. Nabilone (Cesamet)- CB 1 agonist. FDA-Approved for 1)Nausea and vomiting associated with chemotherapy 2) Appetite stimulation in wasting illnesses like AIDs. Maybe CBD (or other cannabinoids), and cannabis therefore, offer some things that dronabinol and nabilone don t.

23 Medical Indications According to Laws MA- debilitating conditions. Laws in various states--cancer, glaucoma, AIDs, Hep C, ALS, Crohn s Disease, Parkinson s, multiple sclerosis. Keep in mind that data suggests that the majority of people with medical marijuana cards do not have one of the above conditions.

24 Medical Indications According to Science Over 50 clinical trials of cannabinoids, including marijuana. Aside from FDA indications, best data (approx. half of studies positive) are for chronic pain, neuropathic pain, and spasticity associated with Multiple Sclerosis. Other data is not positive.

25 MMJ: Where things stand NOW

26 Medical Marijuana in Oregon 10 qualifying conditions and other conditions subject to approval. Patients may hold up to 24oz of usable MMJ at one time. May personally grow up to 6 MJ plants and 18 immature seedlings.

27 Recreational Marijuana in Oregon Recreational users can possess up to eight ounces of usable marijuana in their homes and four plants. Can have 1oz on their person.

28 Boston Globe 1/17/16 We ve Got A Long Way To Go

29 Top 3 MMJ Issues (Using MA as an Example)

30 Issue #1: Quantities MA: 60-day supply = 10 ounces. BUT A certifying physician may determine and certify that a qualifying patient requires an amount of marijuana exceeding ten ounces as a 60-day supply and shall document the amount and the rationale in the medical record and in the written certification. For that qualifying patient, that amount of marijuana constitutes a 60-day supply. My studies: 2.1 oz. per month ± 3.0 oz.

31 Issue #2: Indications MA: Debilitating medical condition such as cancer, glaucoma, AIDS or HIV, Hep C, Crohn s, Parkinson s, MS Or other conditions as determined in writing by physician. Suggestion: other conditions upon approval by DPH (like medication PAs).

32

33 Issue #3: Financial Incentives Automatic hardship for MassHealth, SSI patients. They are granted hardship to grow their own. Will this lead to unintended consequences?

34 (No Longer) Hypothetical Scenario Mr. A, a patient on MassHealth, gets MMJ card to treat his migraine headaches. He smokes ¼ ounce a week, or 2 ounces per 60 days. He recognizes that he can grow another 8 ounces (approximate street value of $3200, or $19,200 per year).

35 MMJ: Suggestions on what you should do Have a policy! Engage in conversation about why the patient feels this may help. Be open to evaluating patients who want it yours or colleagues.

36 The Appropriate Candidate Debilitating condition with evidence. Multiple failed trials of first- and secondline treatments. Failed trial of FDA-approved cannabinoid. No active Axis I condition.

37 Best Practices Ensure purity and potency. Avoid edibles resembling candy or childoriented food products. Avoid high potency extractions (wax, shatter). Require all dispensaries to participate in DEA Prescription Monitoring programs.

38 Best Practices Mandatory informed consent (driving, heavy machinery). Patient education kiosks at dispensaries, again documenting risks (including onset of action of edibles). Ensure an efficient mechanism for reporting AEs.

39 Best Practices Support CME for medical professionals and dispensary staff. Ensure an ongoing doctor-patient relationship with regular follow-up consistent with general medical practice. Dedicate a percentage of gross revenues to education.

40 Policy Ahead of the Science

41 Critical Period Trends are ominous- MTF data. We can provide a service to patients and colleagues by being informed and thoughtful on this topic. There still may be an opportunity to shape the MMJ regulations.

42 Acknowledgments Matt Palastro Roger Weiss Norfolk County DA Office Hawaii Medical Association

43 Questions?

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