Frederick J GoldsteinPhiladelphia College of Osteopathic Medicine, USA
Title: Clinical pharmacology of Marijuana
Within the United States, approval of medical and recreation use of marijuana has occurred at the state but not federal level. It remains classified as a Drug Enforcement Agency (DEA) Schedule I product but sales in states are robust, with control ranging from basically none to requirement of physician certification only for a medical purpose. In addition to purchases of the plant in various forms, active substances extracted such as delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are also available at retail stores. However, due to the federal restriction, such transactions can occur with products grown only in each specific state, i.e., interstate commerce would be a major federal violation. . Self-treatment of many conditions includes anxiety, post-traumatic stress disorder (PTSD) and, most significant, chronic pain. However, high-level clinical research needed to document such applications is lacking. The endogenous cannabinoid (ECB) system is extremely varied and complex. Anandamide, the ECB neurochemical, acts on cannabinoid-1 (CB1) receptors located primarily in the CNS and CB2 receptors found mostly in the PNS. More than 20 physiologic actions, including hunger, memory and pain are influenced by the ECB system. Clinical pharmacological aspects of THC will be discussed including addiction liability, mechanisms of action, dosage as related blood and breath levels, fatality rate, acute and chronic adverse effects, potential teratogenic effects, and therapeutic uses. In the USA, THC is available as nabilone (DEA Schedule II) and dronabinol (DEA Schedule III) prescription products which are FDA-approved for administration as appetite stimulants and antiemetics. CBD (not DEA-scheduled) is officially sanctioned for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. Although numerous studies have found some evidence supporting analgesic efficacy of cannabinoids across various pain disorders, they are not currently FDA-approved for treatment of chronic neuropathic pain (NP). In an ongoing pilot study led by Dr. Goldstein, daily doses of THC over a four-week period have been shown to reduce pain scores and use of other analgesic medications in patients with chronic NP; these data will be presented.
Frederick J. Goldstein, PhD, a Fellow in Clinical Pharmacology (FCP) of the American College of Clinical Pharmacology, is Professor of Clinical Pharmacology, Department of Bio-Medical Sciences at the Philadelphia College of Osteopathic Medicine (PCOM). Here he serves as Coordinator of Pharmacology for the medical school. He also lectures in Pharmacology at the University of Pennsylvania School of Dental Medicine. For the past 39 years, he has conducted human studies to improve analgesia in patients at seven sites including initially at Walter Reed Army Medical Center, and subsequently in Philadelphia at Einstein, Jefferson and Methodist medical centers. At PCOM he is investigating the efficacy of adding THC to improve analgesia in chronic neuropathic pain patients who currently take other analgesic drugs (including opioids) with little or no success. From his clinical experience, he created the term suicidogen, defined as any factor that causes a person to think about and possibly commit suicide; it was published in 1997 (if tthe exact word is searched, his paper will appear). He has many other publications, and has received grants to support his research. Dr. Goldstein serves on the Editorial Board of the Journal of Opioid Management where he reviews papers, and also serves as a reviewer for the Journal of Osteopathic Medicine. His memberships include the Rho Chi Honor Society, American Society for Pharmacology and Experimental Therapeutics, American College of Clinical Pharmacology, and International Association for the Study of Pain. Dr. Goldstein received his Ph.D. in Pharmacology from the University of the Sciences in Philadelphia where he was honored with the Lindback Award for Distinguished Teaching in 1990.