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Disclosure Objectives 4/3/2019 Disclosure Kevin Schleich reports no actual or potential conflicts of interest associated with this presentation. www.google.com/images_cheech&chong Objectives • Review historical context of medical cannabis and literature that addresses efficacy of cannabis for multiple medical conditions • Discuss safety concerns from both an acute and chronic use standpoint • Compare and contrast available formulations of medical cannabis in Iowa • Highlight the process by which patients in Iowa can receive medical cannabis • Summarize the Department of Family Medicine’s (DFM) policy on medical cannabis 1 4/3/2019 Weed 101 • Marijuana contains numerous extractable substances – Steroidal components – Volatile compounds • 60 cannabinoids can be isolated – Delta‐9‐tetrahydrocannabinal (THC): main psychoactive cannabinoid • Dronabinol (Marinol®) – Cannabidiol (CBD): main non‐psychoactive cannabinoid • Agents non FDA‐approved in US, but currently investigational (Nabiximol®, Sativex®, Epidiolex®) Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. Weed 101 • Two main cannabinoid receptors throughout the human body – CB1: brain, spinal cord, some periphery – CB2: intestinal tract, peripheral organs, immune system • Neither CBD or THC directly agonize either the CB1 or CB2 receptor – THC a partial agonist of CB1 – CBD influences endogenous cannabinoids Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations.. http://sensipharma.com/ecs Weed 101 • CBD antagonizes the effects of THC at the CB1 receptor THC THC + CBD • CBD + THC CBD – Pain relief – Anti‐spasmodic • CBD only – Epilepsy Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. www.analyticalcannabis.com 2 4/3/2019 Iowa Qualifying Conditions • Cancer, AIDS/HIV, or any terminal illness if: – Severe/chronic pain – Nausea/severe vomiting – Cachexia or severe wasting • Neuromuscular disorders: – Multiple sclerosis (with severe/persistent muscle spasms) – Amyotrophic lateral sclerosis (Lou Gehrig’s Disease) – Parkinson’s disease • Seizures (including those characteristic of epilepsy) • Crohn’s disease • Untreatable pain – “…any pain whose cause cannot be removed… the full range of pain management modalities have been used without adequate result” – accounts for ~90% of clientele in legal states Does the Stuff Work? www.google.com/images Efficacy Data • The National Academies of Sciences, Engineering, and Medicine (NASEM) – “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research” – Comprehensive report highlighting the health effects of recreational/therapeutic cannabis use – Published in 2017 http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx 3 4/3/2019 Efficacy Data • Chronic Pain – “…there is substantial evidence that cannabis is an effective treatment for chronic pain in adults” – NASEM cites 5 systematic reviews (n=2454) • Low‐quality evidence • 2 studies focused on fibromyalgia • Pain scores decreased by ~30% on average – Generally, higher THC content = greater pain relief – 31 active trials on clinicaltrials.gov Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx www.clinicaltrials.gov Efficacy Data • Cancer‐Associated Symptoms – Dronabinol and nabilone approved in 1985 for nausea/vomiting (n/v) associated with chemotherapy – “…conclusive evidence that oral cannabinoids are effective antiemetics…” • Dronabinol = ondansetron for delayed n/v • No evidence that combined CBD:THC products are effective – “…insufficient evidence to support or refute the use of cannabinoids for cancer‐associated anorexia‐cachexia • Limited evidence that cannabinoids can be useful for HIV/AIDS‐related anorexia and weight loss • Very little primary literature evaluating CBD:THC combinations Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx www.clinicaltrials.gov Efficacy Data • Seizure Management – “… no or insufficient evidence to support or refute that cannabis or cannabinoids are effective for seizure management” – NASEM cites 2 systematic reviews (n<50) • Small numbers of patients • Low quality evidence – Further case series have been published demonstrating 25‐100% reduction in seizure frequency • 3 current trials active on clinicaltrials.gov – Most studies used only CBD Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx www.clinicaltrials.gov 4 4/3/2019 Efficacy Data • Multiple Sclerosis (MS) Spasticity – “…substantial evidence that oral cannabinoids are an effective treatment for improving patient‐reported MS spasticity symptoms” – “… limited evidence for an effect on clinician‐ measured spasticity” – NASEM cites 2 systematic reviews (n=2138) • Reduction (non‐statistically significant) in Ashworth score for spasticity • Balanced 1:1 ratio of THC/CBD products predominantly used – 2 active trials on clinicaltrials.gov Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx www.clinicaltrials.gov Efficacy Data • Parkinsonism – “…insufficient evidence that cannabinoids are an effective treatment for the motor system symptoms associated with Parkinson’s disease or the levodopa‐ induced dyskinesias” – NASEM cites 1 systematic review (n=26) – Randomized‐controlled trial completed since NASEM publications suggests improvement in quality of life and motor symptoms (n=21) • CBD alone was main ingredient studied – 4 active trials on clinicaltrials.gov Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx www.clinicaltrials.gov Efficacy Data • Irritable Bowel Syndrome (IBS) – “… insufficient evidence to support or refute that cannabis is an effective treatment for IBS” – NASEM cites only 1 relevant trial (n=36) • No effect of dronabinol on GI transit – Trial evaluated by NASEM only utilized synthetic cannabinoid, dronabinol – Some trials have demonstrated symptom improvement • No evidence of anti‐inflammatory effect – 1 active trial on clinicaltrials.gov http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx Gastroenterol Hepatol (N Y). 2016 Nov; 12(11): 668–679 5 4/3/2019 Efficacy Data • NASEM addresses efficacy for indications not approved in the state of Iowa Indication Efficacy Statement “…limited evidence that cannabinoids are effective for improving Anxiety situational anxiety symptoms” “…moderate evidence that cannabinoids are effective for Sleep disturbances improving short‐term sleep outcomes in those with obstructive sleep apnea, fibromyalgia, chronic pain, and MS” “…limited evidence that cannabinoids are ineffective for improving Dementia symptoms” “…limited evidence that cannabinoids are ineffective for reducing Depression depressive symptoms” Post‐traumatic stress “…there is no evidence to support or refute an association disorder (PTSD) between cannabis use and development of PTSD Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx Condition Efficacy Studied Product(s) Chronic Pain 1:1 CBD/THC* Cancer/HIV‐Related Symptoms THC (Dronabinol) Seizures CBD MS Spasticity Symptoms 1:1 CBD/THC Parkinson’s CBD Irritable Bowel Synthetic cannabinoids Situational Anxiety CBD Sleep Disturbances Semi‐synthetic cannabinoids Dementia Semi‐synthetic cannabinoids Depression Semi‐synthetic cannabinoids PTSD Variety * Higher doses of THC = greater pain control Herman, Ronald A. (2018). Current Iowa Medical Cannabis Regulations. http://www.nationalacademies.org/hmd/Reports/2017/health‐effects‐of‐cannabis‐and‐cannabinoids.aspx www.google.com/images 6 4/3/2019 Short‐Term Adverse Effects • Marijuana inhalation/ingestion Impaired motor coordination Short-term memory Paranoia/psychosis impairment Dry mouth Tachycardia Hypertension Nausea/ vomiting www.google.com/images N Engl J Med. 2014;371(9):879 Long‐Term Adverse Effects Addiction* Altered brain • 9%: overall development* • 17%: begin as adolescent • 25‐50%: daily user Worsening educational Cognitive outcomes* impairment* Diminished life Increased risk of satisfaction* chronic psychosis disordersΩ * = effect strongly Ω = in those with a associated with initial use predisposition to such in adolescence disorders Adverse Effects in Studies CBD Solution Children With Epilepsy (n=213) > 10% 5‐10% < 5% Somnolence (21%) Increased appetite (7%) Sedation (3%) Fatigue (17%) Weight gain (6%) Decreased appetite (15%) Weight loss (5%) Diarrhea (14%) Convulsions (5%) Gait disturbance (5%) Devinsky, Orrin. 2015,. “Epidiolex (Cannabidiol) in Treatment Resistant Epilepsy”. Washington, DC. www.google.com/images 7 4/3/2019 “Pharmacy stuff… pharmacy stuff… pharmacy stuff… pharmacy stuff… pharmacy stuff” www.google.com/images Pharmacokinetics Sublingual Trans‐ Inhaled Oral /Buccal cutaneous Onset Seconds 5‐15 min ? 60 min Time to Peak 30 min 4 hours ? 4‐6 hours Duration 2‐4 hours ? ? > 8 hours Absorption < inhaled 10‐35% CBD > THC ~5% Bioavailability > oral • Distributes readily into well‐vascularized organs (lung,
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