The Health Effects of Cannabis and Cannabinoids The Current State of Evidence and Recommendations for Research (2017) / Chapter Skim
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15 Challenges and Barriers in Conducting Cannabis Research
15 Challenges and Barriers in Conducting Cannabis Research
Pages 377-394
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From page 377... ...
.2 In November 2016, voters in California, Maine, Massachusetts, and Nevada approved ballot initiatives to legalize recreational cannabis, while voters in Arkansas, Florida, Montana, and North Dakota approved ballot initiatives to permit or expand the use of cannabis for medical purposes (NORML, 2016b)
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From page 378... ...
The committee identified several barriers to conducting basic, clinical, and population health research on cannabis and cannabinoids, including regulations and policies that restrict access to the cannabis products that are used by an increasing number of consumers and patients in state-regulated markets, funding limitations, and numerous methodological challenges. The following sections discuss these barriers in detail.
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From page 379... ...
. To safeguard against the acquisition of cannabis or cannabinoids for nonresearch purposes, investigators must also apply for a DEA registration and site licensure before conducting studies involving cannabis or any of its cannabinoid constituents, irrespective of their pharmacologic activity.5 The investigator must submit the IND and LOA to the FDA and the DEA for review (FDA, 2015)
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From page 380... ...
accepted medical use and can be prescribed with a controlled substance prescription (DEA, 2006) .9 In some states, researchers conducting clinical research on cannabis or cannabinoid products must also apply for and receive a controlled substance certificate from a state board of medical examiners or a controlled substance registration from a department of the state government in order to conduct clinical trials or any other activity involving Schedule I substances (Alabama Board of Medical Examiners, 2013; MDHSS, n.d.)
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From page 381... ...
. DEA security requirements include storing cannabis in a safe, a steel cabinet, or a vault, and limiting access to the storage facility to "an absolute minimum number of specifically authorized employees.12 The extent of the security measures required by DEA varies with the amount of cannabis being stored,13 and among local DEA jurisdictions (Woodworth, 2011)
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16 In fiscal year 2015, NIDA's investment in cannabinoid research totaled $66,078,314, of which $10,923,472 was allocated for therapeutic cannabinoid research (NIDA, 2016c)
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. As mentioned above, NIDA has sought public comment on the needs of cannabis researchers in order to inform efforts to "expand access to diverse marijuana strains and products for research purposes" (NIDA, 2016e)
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In light of these findings, a comprehen 21 $66,078,314 (Total NIDA spending on cannabinoid research in fiscal year 2015) / $111,275,219 (Total NIH spending on cannabinoid research in fiscal year 2015)
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CONCLUSION 15-3 A diverse network of funders is needed to support cannabis and cannabinoid research that explores the harmful and beneficial health effects of cannabis use. METHODOLOGICAL CHALLENGES Drug Delivery Challenges Another challenge in investigating the potential health effects of cannabis and cannabinoids is the identification of a method of administering the drug that is accepted by study participants, that can be performed at most research sites, and that ensures standardized dosing.
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From page 386... ...
.23 The extraction process seems to retain the terpenoids and flavonoids so that the combusted placebo material smells similar to the true cannabis, thus helping to preserve the blinding to some extent. However, the psychoactive and vasoactive effects of cannabis pose a considerable challenge for effective blinding, since study participants who feel such 23 In December 2016, placebo cannabis provided by NIDA was generally free for NIH sponsored research.
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From page 387... ...
For example, if the cannabis being studied has a very low THC content, study participants -- especially those who, through regular use of more potent cannabis strains, are inured to the psychoactive effects of cannabis with low THC content -- may not notice the psychoactive effects of the cannabis and therefore be unable to reliably determine whether they are using cannabis or a placebo. There is also a possibility that cannabis products with a lower ratio of the concentration of THC to the concentration of CBD may have less psychoactivity than products with a comparatively higher ratio of the concentration of THC to the concentration of CBD (Hindocha et al., 2015; Jacobs et al., 2016)
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From page 388... ...
Despite this association and the confounding effect of polysubstance use on evaluations of the health effects of cannabis use, surveys used to characterize cannabis exposure histories do not always assess for the presence of other substance use. Since secondhand exposure to cannabis smoke can have minor health effects, there may also be value in assessing for such exposure as part of larger assessments of cannabis exposure (Herrmann et al., 2015)
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From page 389... ...
There are several challenges and barriers in conducting cannabis and can nabinoid research, including • T here are specific regulatory barriers, including the classification of canna bis as a Schedule I substance, that impede the advancement of cannabis and cannabinoid research (15-1) • I t is often difficult for researchers to gain access to the quantity, quality, and type of cannabis product necessary to address specific research questions on the health effects of cannabis use (15-2)
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From page 390... ...
In Practitioner's Manual: An Informational Outline of the Controlled Substances Act. Washington, DC: Drug Enforcement Administration.
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:381–389. Marijuana Business Daily Staff.
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2016d. Marijuana plant material available from the NIDA drug supply program.
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2011. Identification of recent cannabis use: Whole-blood and plasma free and glucuronidated cannabinoid pharmacokinetics following controlled smoked cannabis administration.
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