Safety and Pharmacokinetics of Oral Cannabidiol When Administered Concomitantly with Intravenous Fentanyl Rajita Sinha, Phd, Didier Jutras-Aswad, MD, MS, Marilyn A

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Safety and Pharmacokinetics of Oral Cannabidiol When Administered Concomitantly with Intravenous Fentanyl Rajita Sinha, Phd, Didier Jutras-Aswad, MD, MS, Marilyn A ORIGINAL RESEARCH Safety and Pharmacokinetics of Oral Cannabidiol When Administered Concomitantly With Intravenous Fentanyl 08/15/2018 on BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3XI41p+sDLxYskzzWJHpwFPA3MvB4/FX5gh6vcjyLLl1kCfZEXLPTKQ== by https://journals.lww.com/journaladdictionmedicine from Downloaded in Humans Downloaded Alex F.Manini, MD, MS, Georgia Yiannoulos, MS, Mateus M. Bergamaschi, PhD, from Stephanie Hernandez, MD, MS, Ruben Olmedo, MD, Allan J. Barnes, BSc, Gary Winkel, PhD, https://journals.lww.com/journaladdictionmedicine Rajita Sinha, PhD, Didier Jutras-Aswad, MD, MS, Marilyn A. Huestis, PhD, and Yasmin L. Hurd, PhD Results: SAFTEE data were similar between groups without res- Objectives: Cannabidiol (CBD) is hypothesized as a potential treat- piratory depression or cardiovascular complications during any test ment for opioid addiction, with safety studies an important first step session. After low-dose CBD, tmax occurred at 3 and 1.5 hours in for medication development. We determined CBD safety and phar- by sessions 1 and 2, respectively. After high-dose CBD, tmax occurred at BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3XI41p+sDLxYskzzWJHpwFPA3MvB4/FX5gh6vcjyLLl1kCfZEXLPTKQ== macokinetics when administered concomitantly with a high-potency 3 and 4 hours in sessions 1 and 2, respectively. There were no signif- opioid in healthy subjects. icant differences in plasma CBD or cortisol (AUC P = NS) between Methods: This double-blind, placebo-controlled cross-over study of sessions. CBD, coadministered with intravenous fentanyl, was conducted at Conclusions: Cannabidiol does not exacerbate adverse effects asso- the Clinical Research Center in Mount Sinai Hospital, a tertiary care ciated with intravenous fentanyl administration. Coadministration of medical center in New York City. Participants were healthy volunteers CBD and opioids was safe and well tolerated. These data provide the aged 21 to 65 years with prior opioid exposure, regardless of the foundation for future studies examining CBD as a potential treatment route. Blood samples were obtained before and after 400 or 800 mg for opioid abuse. of CBD pretreatment, followed by a single 0.5 (session 1) or 1.0 μg/kg (session 2) of intravenous fentanyl dose. The primary outcome was the Key Words: cannabidiol, cannabis, opioid dependence, pharmacoki- Systematic Assessment for Treatment Emergent Events (SAFTEE) to netics assess safety and adverse effects. CBD peak plasma concentrations, (J Addict Med 2015;9: 204–210) time to reach peak plasma concentrations (tmax), and area under the curve (AUC) were measured. annabidiol (CBD), a bioactive cannabinoid in marijuana C (Cannabis sativa), has received significant attention re- From the Division of Medical Toxicology (AFM, SH, RO), Department of cently regarding its potential medicinal properties. A growing Emergency Medicine, The Icahn School of Medicine at Mount Sinai, body of literature has reported therapeutic CBD effects for New York,NY; Departments of Psychiatry and Neuroscience (GY, YLH), The Icahn School of Medicine at Mount Sinai, and James J Peters VA diverse disease processes including inflammation and cancer Medical Center, Bronx, NY; Department of Clinical, Toxicological and (Mechoulam et al., 2007; Massi et al., 2013; Mecha et al., Food Sciences Analysis (MMB), School of Pharmaceutical Sciences of 2013). Moreover, CBD has been shown to have anxiolytic Ribeirao˜ Preto, University of Sao˜ Paulo, Brazil; Chemistry and Drug properties (Fusar-Poli et al., 2009; Crippa et al., 2011) as well Metabolism (AJB, MAH), Intramural Research Program, National Insti- tute on Drug Abuse, NIH, Baltimore, MD; Department of Oncological Sci- as therapeutic potential for psychosis (Borgwardt et al., 2008; ences (GW), The Icahn School of Medicine at Mount Sinai, New York,NY; Muller-Vahl¨ & Emrich, 2008; Leweke et al., 2012; Englund Department of Psychiatry (RS), Yale University School of Medicine, New et al., 2013). Importantly, CBD does not impair motor or cog- on Haven, CT; and Research Center (DJA), Centre Hospitalier de l’Universite´ 08/15/2018 nitive performance (Zuardi et al., 1982; Crippa et al., 2004), de Montreal,´ and Department of Psychiatry, University of Montreal, which is important for medication development. Montreal, Canada. Received for publication October 2, 2014; accepted January 11, 2015. Recent research has also suggested CBD to have poten- Supported by a research grant from the National Institutes of Health grant tial therapeutic effects for opioid abuse on the basis of preclin- DA027781 (YLH) and CTSA (UL1RR029887). ical rat studies that demonstrated CBD to inhibit reinstatement This content is solely the responsibility of the authors and does not necessarily of heroin-seeking behavior (Ren et al., 2009). Interestingly, the represent the official views of the National Institute on Drug Abuse or the National Institutes of Health. effects of CBD were observed to be specific to cue-induced The authors declare no conflicts of interest. relapse behavior and CBD continued to inhibit heroin seeking Send correspondence and reprint requests to Yasmin L. Hurd, PhD, Icahn even 2 weeks after administration. Other animal studies have School of Medicine at Mount Sinai, New York, NY 10029. E-mail: also reported CBD to reduce the rewarding effects of mor- [email protected]. phine (Katsidoni et al., 2013). These preclinical studies suggest Copyright C 2015 American Society of Addiction Medicine ISSN: 1932-0620/15/0903-0204 CBD might be a potential treatment for opioid abuse. Identifi- DOI: 10.1097/ADM.0000000000000118 cation of novel treatments for opioid dependence is important r 204 J Addict Med Volume 9, Number 3, May/June 2015 Copyright © 2015 American Society of Addiction Medicine. Unauthorized reproduction of this article is prohibited. r J Addict Med Volume 9, Number 3, May/June 2015 Safety and Pharmacokinetics of Oral Cannabidiol because there are growing public health concerns regarding the tion, DSM-IV (SCID-IV) interview; history of cardiac disease, abuse, morbidity, and mortality from opioids. Opioid depen- arrhythmias, head trauma, seizures, or Axis I psychiatric con- dence is a chronic, relapsing medical disorder characterized by ditions under DSM-IV examined with the Mini-International drug craving, a persistent compulsion to use the drug with loss Neuropsychiatric Interview; hypersensitivity to any opioid or of control and profound drug-seeking behavior. The fact that cannabinoid; pregnant or breastfeeding; not using an appro- heroin relapses vulnerability is linked to cue-induced craving priate method of contraception; or intoxication at the time of response in opioid-dependent patients highlights the critical arrival on the site of the study or positive drug screen (screened need to develop therapeutic agents that diminish drug craving for cocaine, cannabis, opiates, benzodiazepines, barbiturates, in this population (Fatseas et al., 2011). phencyclidine, amphetamines). Subjects were compensated No specific data presently exist regarding CBD tolera- $150 per session and $10 for screening; compensation was bility and safety in regard to the interaction with opioids in determined on the basis of minimum wage, hours required humans, which is a critical first step for future clinical trials for study participation, and transportation fees. We enrolled to examine CBD’s potential as a therapy for opioid craving 6 subjects per study group similar to CBD studies using the and relapse in human abusers. As such, the objective of the same dose range in healthy subjects (Crippa et al., 2004). current study was to first determine the safety and pharmacoki- netics of CBD when administered concomitantly with opioid Study Protocol in healthy human subjects. On the basis of previous investiga- During this 2-session, double-blind design, participants tions showing CBD to be safe (Zuardi et al., 1993, 2006; Crippa were administered placebo (group 1), 400 mg of oral CBD et al., 2004; Fusar-Poli et al., 2009), we hypothesized that CBD (group 2), or 800 mg of oral CBD (group 3) before both safety and pharmacokinetics would remain unchanged when 0.5 μg/kg (session 1) and 1.0 μg/kg (session 2) of IV fentanyl. coadministered at moderate doses (400-800 mg) with intra- Sessions were separated by at least 1 week to ensure a sufficient venous (IV) fentanyl. drug washout period. All participants were administered both doses of fentanyl with the low dose in the first session and the METHODS high dose in the second (Table 1). Study Design Fentanyl was coadministered with oral CBD in healthy Drugs human volunteers at the Clinical Research Center in Mount Cannabidiol, 99.9% pure CBD in corn oil, was encapsu- Sinai Hospital in New York City on the basis of the exper- lated in gelatin capsules and supplied by GW Pharmaceutical. imental design required by the Federal Drug Administration Placebo was corn oil in gelatin capsules identical to CBD and the Institutional Review Board at Mount Sinai as the first capsules. phase to subsequently examine CBD as a potential medication IV administration was selected because it is the route in opioid abusers. The design was a double-blind, placebo- of administration for many opioid users and minimizes in- controlled cross-over study. All volunteers signed a written terindividual variation in bioavailability noted with oral opi- informed consent document. A Data Safety and Monitoring oid administration (Glare & Walsh, 1991). Fentanyl was safely Board reviewed and approved
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