Medical Marijuana Update: Evidence vs. Reality

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1 Outline Medical Marijuana Update: Evidence vs. Reality Michael G. McDonell, PhD Associate Professor, Elson S Floyd College of Medicine Chair, Committee for Cannabis Research and Outreach mmcdonell@wsu.edu Prevalence of cannabis use and associated disorders Legal status of cannabis in relation to research Therapeutic Treatments Health Risks Psychosocial Associations Mental Health Current Studies 1 Prevalence of Cannabis Use A 2015 national survey reported that 22.2 million Americans (aged 12 or older) identify as current cannabis users. Cannabis use is increasing across the country and across age groups, particularly youth and older adults. 24.9% of youth have used cannabis at least once by 8 th grade. 51.4% of youth have used cannabis by high school graduation. Prevalence of Cannabis use and Associated Disorders Cannabis use disorder is recognized by APA as a psychiatric disorder. 4.2 million adults in the US have a current cannabis use disorder. Cannabinoid-Based Medications Evolving State Cannabis Laws Two drugs have been approved by the FDA: Dronabinol Synthetic Delta-9 THC Nabilone synthetic analog of Delta-9 THC These drugs target nausea and vomiting associated with chemotherapy and appetite stimulation in HIV or cancer. 6 Courtesy of Newsweek 1/2/18

2 Overview of the Federal Legal Landscape Cannabis possession, distribution, cultivation is still illegal (criminal) under the Controlled Substances Act. Limited exceptions allow certain research involving cannabis possession, distribution or cultivation (e.g., research conducted under a DEA Schedule I license). This is a still-evolving area. Rescission of Cole Memo Pending proposals for regulatory/statutory reform as well as legal challenges Key Federal Agency Regulatory Roles DOJ/Drug Enforcement Agency (DEA) Primary federal agency charged with enforcing Controlled Substances Act NIH/NIDA supports scientific research; designated by DEA as the government agency overseeing cultivation of marijuana for medical research (under contract to University of Mississippi). FDA Scientific assessment used for scheduling; regulates research on potential therapeutic uses; enforcement of products containing MJ compounds (health risks, illegal claims in labeling) Challenges to Research on Cannabis Efficacy There are numerous federal restrictions, requirements, and approvals for RCTs Research Challenges: Multiple cannabis formulations, routes & dosages Multiple diseases & conditions of interest Blinding effectiveness challenge for RCTs Dependence on self-report for most outcomes Small size & short duration of most studies Funding, funding, funding Credit: Yellowj/Shutterstock.com

3 National Academy of Science Report: The Health Effects of Cannabis and Cannabinoids Address Research Gaps Clinical and Observational Research Health Policy and Health Economics Research Public Health and Public Safety Research Improve Research Quality Improve Surveillance Capacity Address Research Barriers Therapeutic Treatments with Conclusive or Substantial Evidence Treatment of chronic pain in adults Treatment of chemotherapy-induced nausea and vomiting Improving patient-reported multiple sclerosis spasticity symptoms tvirbickis/thinkstock Chronic Pain Chemotherapy-induced nausea and vomiting 94% of Colorado Medical Marijuana cardholders are treated for severe pain (Light 2014). One study found that plant-derived cannabinoids increased the odds for improvement in pain levels by 40% (Whiting 2015). Other studies found a reduction in acute pain is suggested after cannabis use. Most clinical trials are done outside of the U.S., meaning little is revealed in these studies about the efficacy of cannabis used in the U.S.. Nabilone and dronabinol were approved in 1985 for nausea and vomiting associated with cancer chemotherapy. Studies in the 80s led to recommendations that cannabinoids only be used when the first line treatments failed. Most evidence for cannabis is anecdotal and effective studies have not been conducted due to research barriers. Bottom line: oral cannabinoids are effective antiemetics for chemo-induced nausea and vomiting Whiting, P. F., R. F. Wolff, S. Deshpande, M. Di Nisio, S. Duffy, A. V. Hernandez, J. C. Keurentjes, S. Lang, K. Misso, S. Ryder, S. Schmidlkofer, M. Westwood, and J. Kleijnen Cannabinoids for medical use: A systematic review and metaanalysis. Journal of the American Medical Association 313(24): Improving patient-reported multiple sclerosis spasticity symptoms Patient-reported studies showed an improvement in spasticity, regardless of the type of cannabinoid. Substantial Evidence: self-reported modest effect Limited Evidence: clinician-measured spasticity Sleep Disorders Moderate Evidence of Effectiveness Patients with obstructive sleep apnea found improvement in a clinical trial for dronabinol (synthetic delta-9 THC) Dronabinol found to be safe and well-tolerated Dronabinol reduced Apnea Hypopnea Index by approximately onethird over 3 weeks of oral administration Patients with sleep issues from fibromyalgia found improvements with nabiximols. Other trials show small improvements with various administration and sleep conditions. Ville Magazine

4 Limited Evidence of Effectiveness Limited Evidence of Effectiveness Increasing appetite and decreasing weight loss associated with HIV/AIDS or anorexia Some studies suggest effectiveness. Studies have been small, with short durations. Improving symptoms of Tourette syndrome (THC capsules) No clear link yet Effects shown in case studies may be due to reduced anxiety, another possible effect of cannabis. Statistical association between cannabinoids and better outcomes (i.e., mortality, disability) after a traumatic brain injury or intracranial hemorrhage Observational studies show some evidence of improved outcomes. More trials, including clinical trials, are necessary. Improving anxiety symptoms, as assessed by a public speaking test, in individuals with social anxiety disorders (cannabidiol) Role of the endocannabinoid system in mood regulation suggests studies are needed in this area. However, observational studies show moderate evidence that increased anxiety results from daily cannabis use, and social phobia disorder is associated with heavy cannabis use. Improving symptoms of post-traumatic stress disorder Limited results suggest effectiveness. More trials are underway that may lead to stronger evidence or conclusions. Behavioral therapies have a high success rate. May be less effective because of cannabis use Ineffectiveness There is limited evidence that cannabis or cannabinoids are ineffective for several conditions Dementia Glaucoma Depression in patients with chronic pain or multiple sclerosis Possible Treatments No or insufficient evidence to support or refute effective treatment Cancers, including glioma Cancer-associated anorexia Symptoms of irritable bowel syndrome Epilepsy (cannabinoids) (4-6) Spasticity in patients with paralysis due to spinal cord injury Amyotrophic lateral sclerosis symptoms Huntington s disease Motor system symptoms associated with Parkinson s Dystonia Achieving abstinence in the use of addictive substances Mental health outcomes in individuals with schizophrenia or schizophreniform Limited Evidence: Non-seminoma-type testicular germ cell tumors Triggering acute MI Ischemic Stroke Subarachnoid hemorrhage Prediabetes COPD Decreased immune function Maternal complications NICU admissions Moderate Evidence: Pediatric populations at risk of overdose injuries and respiratory distress Substantial Evidence: Worsened respiratory symptoms Chronic bronchitis Motor vehicle crashes Low birthweight Acute MI Current cannabis use is low (~2%) in older populations most at risk of cardiometabolic disease Cannabis effects: Increased HR Increased supine BP Increased risk of postural hypotension Increased rates of irregular heart rate Impaired vascular endothelial function from second-hand smoke exposure CO2 production from smoked cannabis decreases the oxygencarrying capacity of blood triggering of acute MI

5 Stroke Possible mechanisms associated with cannabis use: Orthostatic hypotension Impairment of cerebral blood flow Altered cerebral vasomotor function Supine hypertension and swings in BP Cardioembolism with atrial fibrillation Other arrhythmias Reversible cerebral vasoconstriction syndrome ischemic stroke subarachnoid hemorrhage Diabetes and Prediabetes Effects of THC: Stimulates appetite Promotes fat deposition Promotes adipogenesis Counterintuitive findings: Inverse association or no association with BMI Inverse association with metabolic dysregulation and metabolic association Inverse association or no association with diabetes mellitus Increased risk of prediabetes Decreased risk of metabolic syndrome and diabetes Respiratory Disease Short-term cannabis exposure: Bronchodilation Improvements in peak flow measurements Improvements in forced expiratory volume Long-term cannabis exposure: Lower specific airway conductance (16%) Lower forced expiratory volume Chronic cough and phlegm production Respiratory Disease Increased risk of COPD Moderate evidence: Improved airway dynamics (acute use) but not with chronic use Higher forced vital capacity Substantial evidence: Worsened respiratory symptoms More frequent chronic bronchitis episodes Prenatal, Perinatal, and Neonatal Exposure Endocannabinoids play a role in a broad array of critical neurodevelopmental processes. THC is secreted in breast milk and can accumulate to high concentrations. Cannabis smoking increases carbon monoxide with carboxyhemoglobin blood levels up to 5x higher than after cigarette use. Pregnancy complications NICU admissions Substantial evidence: Lower birth weight Motor Vehicle Crashes Cannabis use associations: Impaired coordination Impaired memory Slowed reaction time Altered thinking Altered judgement Altered sensation Driving under the influence of cannabis is associated with 20-30% higher odds of an MVC. Substantial evidence: increased risk of motor vehicle crashes

6 Overdose Injuries and Death The American Association of Poison Control Centers report 2,047 calls for single-substance exposure to cannabis in 2014 compared to 1,548 exposures in with major effects, 1 death Accidental ingestion of cannabis by young children can result in respiratory failure and coma. Similar symptoms not reported in adults exposed to cannabis Moderate evidence: increased risk of overdose injuries (including respiratory distress) among pediatric populations During adolescence and young adulthood, neural substrates that underlie development of cognition are most active Limited Evidence: Impaired academic achievement and education outcomes Unemployment and/or low income Impaired social functioning or engagement in developmentally appropriate social roles Moderate Evidence: Impaired learning, memory, and attention Memory, Learning, and Attention MRI/fMRI studies found no difference in task performance (cannabis vs. non-cannabis users) but that cannabis users utilized different parts of their brain ( compensatory efforts ) Strong evidence: acute cannabis use interfering in learning Mixed support: sustained effects on learning after cessation of use Strong evidence: acute impact of cannabis on attention Limited/No evidence: sustained effects on attention after cessation of use Academic and Education Outcomes Some studies report negative educational outcomes associated with cannabis use. Those who start cannabis use before 15yo may experience significantly greater negative educational outcomes. There is a positive association between cannabis use and dropout rates (confounded by tobacco use). decreased academic and educational outcomes This Photo by Unknown Employment and Income Some cases show no link between cannabis use and labor market participation and unemployment. In other studies, longer duration of cannabis use was associated with unemployment. Low socioeconomic status may exacerbate outcomes. increased rates of unemployment and/or low income Social Relationships and Social Roles Cannabis use associations: compromised relationships with authority figures poorer functioning in social roles (i.e. employment, parenting) There is a wide range of sociodemographic confounds and effects from other substances and psychological problems. impaired social functioning or engagement in developmentally appropriate social roles

7 Limited Evidence: Increase in positive symptoms of schizophrenia Bipolar disorder Anxiety disorders Increased PTSD severity Moderate Evidence: Better cognitive performance (psychotic disorders, cannabis use history) Increased mania and hypomania (bipolar disorders, regular cannabis users) Depressive disorders Suicidal ideation, suicide attempts, and suicide completion Social anxiety disorder (regular cannabis users) Psychotic Disorders Cannabis use is associated with increased risk of psychosis (dose-specific effect suggested). First-episode psychosis associations: lifetime cannabis use daily cannabis use high-potency cannabis use cannabis use before 15 years old The relationship may be moderated by genetic factors. Substantial Evidence: Development of schizophrenia & other psychoses (highest risk with frequent use) Psychotic Disorders Substantial evidence: developing schizophrenia or other psychoses Moderate evidence: better cognitive performance among those with psychosis increased positive symptoms of schizophrenia Bipolar Disorder Cannabis use associations: increased incidence of bipolar disorders new onset of manic symptoms in those with pre-existing bipolar disorder lower rates of recovery and remission higher rates of recurrence of bipolar disorder Moderate evidence: increased mania and hypomania symptoms in those with bipolar disorders developing bipolar disorder Depression Cannabis use is associated with increased risk of depression and depressive symptoms (dose-specific effect suggested). The effect of cannabis use increases with frequent use. Moderate evidence: small risk for the development of depressive disorders Suicidal Ideation, Attempts, and Completion Cannabis use is associated with increased risk of suicidality. Larger in men who are daily users, not observed in women Suggested dose-specific effect, with heavier cannabis use associated with higher risk of suicidal ideation and attempts Any cannabis use is associated with increased risk of death by suicide. Moderate evidence: increased incidence of suicidal ideation, attempts, and completion

8 Anxiety Cannabis use at treatment baseline is associated with developing symptoms of anxiety at follow-up. Increased frequency of cannabis use is associated with significantly increased odds of incident social anxiety disorder. Development of any type of anxiety disorder Increased anxiety symptoms (Near-daily use) Moderate evidence: Increased incidence of social anxiety disorder (regular use) Post-traumatic Stress Disorder Past 6-month cannabis use associations: Increased PTSD severity Depressive symptoms Suicidality Veterans who continued to use or started using cannabis after discharge had significantly worse PTSD symptoms and greater drug use. In a controlled veteran cohort, cannabis users were more likely to experience suicidal ideation and report more alcohol use (compared to non-users). increased severity of PTSD among those with the disorder Promising Studies Promising Studies Colorado Research Approved by Board of Health Observational Studies Observational study of MJ for PTSD Determine whether persons with PTSD who use MJ will exhibit lower PTSD symptom severity, greater psychosocial functioning, lower suicidal ideation, and less engagement in medical/psychological treatments. Colorado Research Approved by Board of Health Randomized Controlled Trials RCT of MJ (4 potencies THC & CBD) for PTSD in veterans Determine the safety and efficacy of four potencies of smoked marijuana to manage chronic, treatment-resistant PTSD among veterans. Observational study of quality of life in children with CNS tumors who use MJ Determine whether cannabinoid use by children with CNS tumors is associated with changes in quality of life (nausea, anxiety, pain, fatigue, cognitive problems, movement difficulties), and significant impact on families including financially. Observational study of MJ for sleep disorders Determine how MJ is used for sleep disorders/disturbances, and determine the efficacy of MJ use for sleep through home sleep studies. RCT of CBD for tremor in Parkinson s Disease (PD) Determine the safety & tolerability of CBD (Epidiolex) in PD, and the effect of CBD on severity and duration of intractable tremor in PD. RCT of MJ versus oxycodone for chronic spine pain Determine the efficacy of acute cannabis exposure (vaporized) on chronic spine pain relief and evoked experimental pain analgesia, compared to active control (oxycodone) and placebo.

9 Examples of State-Funded WSU studies More Funded Research Projects Therapeutic Benefits Project Pharmacogenetics of THC-COOH Glucuronidation in Human Liver Microsome and Human Intestine Microsome Development of Rapid, Comprehensive Analytical Protocols for Cannabinoid Profiling from Complex Matrices Strain and Sex Differences in the Perceived Efficacy of Medical Marijuana Self-paced Cannabis Vapor Exposure - a Model of Cannabis Abuse The Influence of Chronic Cannabis Use on Stress-Induced Cognitive Inflexibility THC Inhibition of Spontaneous Migraine Pain Preliminary Studies into the Cellular and Physiological Consequences of Exogenous Cannabinoids at TRPA1 and CB1 Receptors in Rat Primary Vagal Afferent Neurons PI Chen, Gang Pharmaceutical Sciences Clowers, Brian Chemistry Cuttler, Carrie Psychology Fuchs Lokensgard, Rita Integrative Physiology and Neuroscience Hinson, John Psychology Morgan, Mike Psychology-Vancouver Peters, Jim Integrative Physiology and Neuroscience Wayman, Gary Effects of Maternal CB1R Agonists on Neuronal Development Integrative Physiology and in the Offspring: Morphological and Proteomic Analysis Neuroscience Characterization of the Role of the Endocannabinoid System in Rheumatoid Arthritis, by Salah-Uddin Ahmed (Rheumatology Research Foundation) CBD-THC treatment of chronic inflammatory pain in male and female rats, by Stevie Christine Britch (WSU OR/ADARP) Endocannabinoids in the Lateral Habenula: A Novel Target for Stress-Related Disorders? by Ryan McLaughlin (WSU OR/ADARP) Research Cited National Academies of Sciences, Engineering, and Medicine The health effects of cannabis and cannabinoids: The current state of evidence and recommendations for research. Washington, DC: The National Academies Press. doi: /24625.

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