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MEDICAL MARIJUANA • 1484: Became Associated with Witchcraft After Papal Decree ANTHONY PAZANESE, PHARM.D

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MEDICAL MARIJUANA • 1484: Became Associated with Witchcraft After Papal Decree ANTHONY PAZANESE, PHARM.D 7/6/2016 EARLY HISTORY • 4000 BCE China: First reported use as foodstuff and cloth NNUAL EETING • 2737 BCE China: First reported medicinal use by Emperor Shen Neng 2016 A M • 430 BCE: Reported recreational use of the Scythians by Herodotus IS IT ALL JUST BLOWN SMOKE? • 100 BCE China: First reported use as paper • 70: Listed in Nero’s Pharmacopoeia by a physician in his army A REVIEW OF MEDICAL MARIJUANA • 1484: Became associated with witchcraft after Papal decree ANTHONY PAZANESE, PHARM.D. CLINICAL PHARMACY SPECIALIST, PAIN MANAGEMENT & PALLIATIVE CARE LAKELAND REGIONAL HEALTH WGBH 2014 Lathrop 2015 2016 ANNUAL MEETING DISCLOSURE MARIJUANA IN THE UNITED STATES • Neither I nor any member of my immediate family has a vested interest in or • 1906: Pure Food and Drug Act passed; defined labeling requirements affiliation with any corporate organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization • 1920s: Prohibition encourages cannabis as a substitute for alcohol whose philosophy could potentially bias my presentation. • 1937: Marihuana Tax Act criminalized the drug • Excise tax of $1 on anyone dealing in cannabis, for certain authorized uses • The “evil weed” causes “murder, insanity, death” • 1941: Cannabis removed from USP http://www.tokeofthetown.com/2012/03/30/ Devils_harvest_poster_01.jpg WGBH 2014 http://all-that-is-interesting.com/20th-century- Lathrop 2015 anti-marijuana-propaganda#12 2016 ANNUAL MEETING 2016 ANNUAL MEETING OBJECTIVES MODERN MEDICAL MARIJUANA • Describe the current legal status of medical marijuana with respect to indications • Early 1960s: Synthetic cannabinoids developed to discover therapeutic value for patients with pain or other palliative care symptoms • 1981: Nabilone (Cesamet®) approved • Discuss the current evidence base for the use of medical marijuana for patients with pain or other palliative care symptoms • 1985: Dronabinol (Marinol ®) approved • 1996: California becomes the first state to legalize medical marijuana use • 2003: Canada becomes the first country to approve medical marijuana • 2012: Colorado and Washington legalize recreational use • 2012: Washington DC decriminalizes use and possession WGBH 2014 Lathrop 2015 2016 ANNUAL MEETING 2016 ANNUAL MEETING 1 7/6/2016 CURRENT LEGAL STATUS PHARMACOKINETICS OF THC • 24 states and DC have enacted laws to legalize medical marijuana • Systemic bioavailability of 27% in heavy users, 14% in occasional users • 16 states have enacted laws to legalize cannabidiol • Systemic bioavailability of 10% taken orally; extensive hepatic metabolism • Legalization in Florida • Active metabolite: 11-OH-THC • SB 1030 signed on June 16, 2014 by Rick Scott • Highly lipophilic and protein bound; crosses blood brain barrier and placenta • Allows use of non-smoked cannabis oil less than 0.8% THC and more than 10% CBD • Peak plasma concentration within 10 minutes after inhaled, 1-2 hours orally • “Charlotte’s Web” • “Qualified patient”: Patients with cancer, chronic seizures, or severe muscle spasms • t1/2 5-13 days in heavy users; 1.3 days in occasional users • Enrollment on the compassionate use registry • Urinary and fecal excretion • Physician Education • 8-hour CME course and subsequent examination by Florida Medical Association • Extreme interpatient variability in serum concentrations ProCon.org 2015 Sharma P, Murthy P, Barath MS 2012 2016 ANNUAL MEETING 2016 ANNUAL MEETING MAJOR CANNABINOIDS DRONABINOL (MARINOL®) • ∆9-THC: Primary psychoactive constituent • Synthetic ∆9-THC • ∆8-THC: Less psychoactive than ∆9-THC • Schedule III • Cannabinol (CBN): Less powerful than ∆9-THC • Significant psychoactivity 9 • 11-OH-∆ -THC: Liable for psychological effects • Mostly affects CB1 receptors, though equal affinity for CB1 and CB2 • Cannabidiol (CBD): Anxiolytic and anticonvulsant effects • Dose based on indication 2 • (-)∆8-THC-11-oic acid: Analgesic activity • Chemotherapy Induced Nausea and Vomiting (CINV): 5-15 mg/m /dose • Appetite stimulant in AIDS or cancer: 2.5-10 mg before lunch and dinner • Duration of 4-6 hours (psychoactive effects); >24 hours (appetite stimulation) http://stashpotshop.com/flower/ http://floridamarijuanainfo.org/wp-content/uploads/2014/06/marinol_211.gif 2016 ANNUAL MEETING 2016 ANNUAL MEETING CANNABINOID PHARMACOLOGY NABILONE (CESAMET ®) • Cannabinoids stimulate two primary G-protein coupled receptors • Similar to ∆9-THC • CB 1 • Schedule II • Cerebral cortex, hippocampus, basal ganglia, cerebellum • Linked to psychotropic effects of THC • Chemotherapy Induced Nausea and Vomiting: 1-2 mg BID • Regulates release of GABA • Frequent psychotomimetic reactions • Cannabinoid tetrad symptoms • Hypothermia, analgesia, catalepsy, locomotor suppression • May persist for 48-72 hours following treatment cessation • Nabilone restricted to patients failing other antiemetic treatments • CB2 • Located in immune and hematopoietic cells; low levels in CNS • Affects CB1 receptors • No psychotomimetic effects • Immunomodulatory, analgesic, anti-inflammatory, and antineoplastic effects http://www.nature.com/nrc/journal/v3/n1 0/box/nrc1188_BX1.html http://www.cesamet.com/hcp-dosing-and-administration.asp 2016 ANNUAL MEETING 2016 ANNUAL MEETING 2 7/6/2016 NABIXIMOLS (SATIVEX®) ACUTE PAIN • GW Pharmaceuticals • Few studies evaluating acute or postoperative pain • Cannabis-based oromucosal spray, containing ∆9-THC and CBD • Most available studies not well designed • Natural product via cold organic solvent • Measurement of tolerance and threshold only • Lack of positive control • Onset of 15-40 minutes allows titration • Naproxen shown to be more effective than placebo and cannabinoid in one study • Approved in Canada for MS-related spasticity and intractable cancer pain • Cannabinoid similar to placebo • Approved in the UK for MS-related spasticity • Surgical removal of impacted third molar • Consistent with most placebo-controlled studies using dronabinol and nabilone • Currently in US Phase III trials for cancer-related pain; no application for MS http://thecompassionchronicles.com/2013/06/24/sativex-marijuana-yes-or-no/ Kalliomaki J, Segerdahl M, Webster L et al 2013 2016 ANNUAL MEETING 2016 ANNUAL MEETING HERBAL CANNABIS NEUROPATHIC PAIN • Lacks standardization • Short term studies among smoked cannabis • Adulteration/contamination problems • Three patient-years of experience over four studies • Longer term studies (≥ 12 weeks) do exist among pharmacological products • Delivery mechanism • Reported efficacy is mixed, with adverse effects a limiting factor • Combustion and Vaporization • Tinctures and Oils • Smoked cannabis or placebo TID x 5 days for HIV sensory neuropathy • Edibles • Cannabis reduced pain by 34%, placebo 17% • Topical • Profile of Mood States did not significantly vary or favored placebo • Difficult to dose • NNT 3.6 for cannabis, 5.4 for lamotrigine, 3.4-4 for gabapentin • Patients can self-titrate Russo EB, Hohmann AG 2013 http://clubcannabisbarcelona.blogspot.com/2013/11/new-international-study-herbal-cannabis.html Chohan H, Greenfield AL, Yadav V et al 2015 2016 ANNUAL MEETING 2016 ANNUAL MEETING ANALGESIC EFFICACY SPASTICITY • Motor effects complicate animal models of pain • One study reviewing smoked cannabis among refractory MS patients • Neurophysical models • Crossover trial using smoked cannabis or placebo cigarette • Treatment reduced Ashworth Spasticity Scores by 2.7 points • Decreased response of pain neurons in spinal cord and thalamus • Treatment reduced pain VAS scores by 5.3 points • Primarily mediated through CB1 to inhibit neurotransmitter release • 17/30 subjects correctly and consistently guessed treatment phase • CB2 suppresses neuropathic pain through non-neuronal and neuronal mechanisms • Dizziness, fatigue more common in cannabis group • CBD (not THC) acts as a TRPV1 agonist • 2014 AAN systematic review of placebo-controlled studies • Pain sensitivity increased when CB1 antagonists given • Oral cannabis extracts with CBD and THC effective in reducing central pain in MS • Synergistic with opioids • Oral cannabis extracts with only THC “probably effective” • Nabiximols “probably effective Russo EB, Hohmann AG 2013 Russo EB, Hohmann AG 2013 Chohan H, Greenfield AL, Yadav V et al 2015 2016 ANNUAL MEETING 2016 ANNUAL MEETING 3 7/6/2016 APPETITE STIMULATION 2008 SYSTEMATIC REVIEW OF CINV • Mediated by CB1 receptor • Cannabinoids viewed as modestly effective compared to gold-standard • Blockade in newborn mice halts milk ingestion • Primarily small, placebo-controlled trials; many not statistically significant • Levels of 2-Arachidionoylglycerol (2-AG) peak immediately after birth in mice • Possible Type-1 error • Stimulation of Anandamide provokes overeating in satiated rats • Trends toward superiority against placebo • Wasting and anorexia common in end-stage disease • THC vs metoclopramide for cisplatin-induced N/V • 47% Metoclopramide, 13% THC completely controlled • Patients tend to prefer cannabis to other antiemetics • Anecdotal reports of smoking more effective than oral Grotenhermen 2004 Grant and Cahn 2005 Joy 1999 Williams CM, Kirkham TC 1999 Machado Rocha FC, Stefano SC, De Cassia Haiek R, et al 2008 2016 ANNUAL MEETING 2016 ANNUAL MEETING APPETITE STIMULATION ADVERSE EFFECTS • AIDS: weight loss of 5% decreases survival • Meta-analysis of 31 studies (23 RCTs) • Dronabinol shown to increase appetite and stable weight • ∆9-THC, ∆9-THC/CBD • Megestrol more effective in stimulating weight gain • 445 person years of exposure • Neither
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