Login Register Cart 0
Generic placeholder image

Current Reviews in Clinical and Experimental Pharmacology

Editor-in-Chief

ISSN (Print): 2772-4328
ISSN (Online): 2772-4336

Back
Journal Home About Journal Editorial Board Current Issue Volumes/Issues
Subscribe
Perspective

Chronic Cannabis Users: A New Special Population to Consider for Drug Development

Author(s): Gina Pastino* and Diana Shuster

Volume 17, Issue 1, 2022

Page: [4 - 7] Pages: 4

DOI: 10.2174/2772432816666210515145638

open access plus

Abstract

The use and acceptance of cannabis, either medically or recreationally, has substantially outpaced the collection of data necessary to evaluate it’s use in any population. However, the mere widespread availability does not imply the absence of risk or confirmation of efficacy and should not be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic and metabolic interactions exist, but also that baseline characteristics for a given population could be different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile for any new drug in development. As such, we encourage drug developers to consider that the cannabis user may very well be a special population that warrants its own clinical pharmacology evaluation.

Keywords: Cannabis, marijuana, clinical pharmacology, delta-9-tetrahydrocannabinol, cannabidiol, special population.

« Previous Next »
[1]
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research Washington (DC) National Academies Press US. 2017.
[2]
National Conference on State Legislatures. State Marijuana Laws 2020. Available at: https://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx#4[Accessed November 19, 2020].
[3]
Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No PEP20-07-01-001, NSDUH Series H-55) 2020. Available at: https://www.samhsa.gov/data/
[4]
US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Botanical Drug Development Guidance for Industry Pharmaceutical Quality/CMC Revision 1, 2016.
[5]
US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. Guidance for Industry 2020.
[6]
Barkan ID. Industry invites regulation: The passage of the Pure Food and Drug Act of 1906. Am J Public Health 1985; 75(1): 18-26.
[http://dx.doi.org/10.2105/AJPH.75.1.18] [PMID: 3881052]
[7]
Hirsch AB. Notes of a case of poisoning from Mrs. Winslow’s soothing syrup. Boston Med Surg J 1884; 111: 370-1.
[http://dx.doi.org/10.1056/NEJM188410161111606]
[8]
Steigerwald S, Wong PO, Khorasani A, Keyhani S. The form and content of cannabis products in the United States. J Gen Intern Med 2018; 33(9): 1426-8.
[http://dx.doi.org/10.1007/s11606-018-4480-0] [PMID: 29770952]
[9]
Dryburgh LM, Bolan NS, Grof CPL, et al. Cannabis contaminants: sources, distribution, human toxicity and pharmacologic effects. Br J Clin Pharmacol 2018; 84(11): 2468-76.
[http://dx.doi.org/10.1111/bcp.13695] [PMID: 29953631]
[10]
Ryan JE, Noeder M, Burke C, Stubblefield SC, Sulieman S, Miller EG. Denying renal transplantation to an adolescent medical cannabis user: An ethical case study. Pediatr Transplant 2019; 23(5)e13467
[http://dx.doi.org/10.1111/petr.13467] [PMID: 31124250]
[11]
Food and drug administration, center for drug evaluation and research, office of clinical pharmacology. Good review practices: Clinical pharmacology review of new molecular entity (NME) New drug applications (NDAs) and original biologics license applications (BLAs) manual of policies and procedures 2016.
[12]
National Advisory Council on Drug Abuse Cannabis Policy Research Workgroup Recommendations for NIDA’s Cannabis Policy Research Agenda Available at: https://www.drugabuse.gov/sites/default/files/nacda_cannabis_policy_research_workgroup_report_feb_2018.pdf
[13]
Food and Drug Administration (FDA) and Cannabis Research and Drug Approval Process Available at: https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process[Accessed November 19, 2020].
[14]
Epidolex® New Drug Application No 210365. Available at: https://www.accessdata.fda.govAccessed November 19 2020.
[15]
Birer-Williams C, Gufford BT, Chou E, et al. A new data repository for pharmacokinetic natural product-drug interactions: From chemical characterization to clinical studies. Drug Metab Dispos 2020; 48(10): 1104-12.
[http://dx.doi.org/10.1124/dmd.120.000054] [PMID: 32601103]
[16]
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Clinical Pharmacology Population Pharmacokinetcs: Guidance for Industry 2019.
[17]
Cox EJ, Maharao N, Patilea-Vrana G, et al. A marijuana-drug interaction primer: Precipitants, pharmacology, and pharmacokinetics. Pharmacol Ther 2019; 201: 25-38.
[http://dx.doi.org/10.1016/j.pharmthera.2019.05.001] [PMID: 31071346]
[18]
Maccarrone M, Bab I, Bíró T, et al. Endocannabinoid signaling at the periphery: 50 years after THC. Trends Pharmacol Sci 2015; 36(5): 277-96.
[http://dx.doi.org/10.1016/j.tips.2015.02.008] [PMID: 25796370]
[19]
Lorenzetti V, Solowij N, Yücel M. The role of cannabinoids in neuroanatomic alterations in cannabis users. Biol Psychiatry 2016; 79(7): e17-31.
[http://dx.doi.org/10.1016/j.biopsych.2015.11.013] [PMID: 26858212]
[20]
Marconi A, Di Forti M, Lewis CM, Murray RM, Vassos E. Meta-analysis of the association between the level of cannabis use and risk of psychosis. Schizophr Bull 2016; 42(5): 1262-9.
[http://dx.doi.org/10.1093/schbul/sbw003] [PMID: 26884547]
[21]
Latif Z, Garg N. The impact of marijuana on the cardiovascular system: A review of the most common cardiovascular events associated with marijuana use. J Clin Med 2020; 9(6): 1925.
[http://dx.doi.org/10.3390/jcm9061925] [PMID: 32575540]
[22]
Rizzo MD, Crawford RB, Bach A, Sermet S, Amalfitano A, Kaminski NEΔΔ. 9-Tetrahydrocannabinol suppresses monocyte-mediated astrocyte production of monocyte chemoattractant protein 1 and interleukin-6 in a toll-like receptor 7-stimulated human coculture. J Pharmacol Exp Ther 2019; 371(1): 191-201.
[http://dx.doi.org/10.1124/jpet.119.260661] [PMID: 31383729]
[23]
Nedumaran B, Rudra P, Gaydos J, et al. Impact of regular cannabis use on biomarkers of lower urinary tract function. Urology 2017; 109: 223.e9-223.e16.
[http://dx.doi.org/10.1016/j.urology.2017.08.011] [PMID: 28827195]
[24]
Pagano S, Coniglio M, Valenti C, et al. Biological effects of Cannabidiol on normal human healthy cell populations: Systematic review of the literature. Biomed Pharmacother 2020; 7(132)110728
[http://dx.doi.org/10.1016/j.biopha.2020.110728] [PMID: 33038581]
[25]
Hu Y, Ranganathan M, Shu C, et al. Single-cell transcriptome mapping identifies common and cell-type specific genes affected by acute Delta9-tetrahydrocannabinol in humans. Sci Rep 2020; 10(1): 3450.
[http://dx.doi.org/10.1038/s41598-020-59827-1] [PMID: 32103029]
[26]
Muniyappa R, Sable S, Ouwerkerk R, et al. Metabolic effects of chronic cannabis smoking. Diabetes Care 2013; 36(8): 2415-22.
[http://dx.doi.org/10.2337/dc12-2303] [PMID: 23530011]
[27]
Cooper ZD, Craft RM. Sex-dependent effects of cannabis and cannabinoids: A translational perspective. Neuropsychopharmacology 2018; 43(1): 34-51.
[http://dx.doi.org/10.1038/npp.2017.140] [PMID: 28811670]
[28]
Gundersen TD, Jørgensen N, Andersson AM, et al. Association between use of marijuana and male reproductive hormones and semen quality: A study among 1,215 healthy young men. Am J Epidemiol 2015; 182(6): 473-81.
[http://dx.doi.org/10.1093/aje/kwv135] [PMID: 26283092]

Rights & Permissions Print Cite
Article Metrics
26
2
1
1
© 2024 Bentham Science Publishers | Privacy Policy