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A September 2022 research study entitled The Naturalistic Cannabis Administration Protocol (NCAP): A Proof-of-Concept Study" that was published in the Journal of Psychoactive Drugs and involved pioneering cannabinoid researcher Dr. Ethan Russo proposed the Naturalistic Cannabis Administration Protocol (NCAP), "a novel paradigm for the study of acute cannabis effects in an ecologically valid manner."
The study reported that "experimental research examining the acute effects of cannabis administration on human behavior has largely been conducted in laboratory settings" and that this controlled environment provides researchers with many benefits, including allowing scientists to "isolate drug effects from other contextual and individual-level variables" and protecting study participants "from the stigma and potential legal consequences of ingesting a controlled substance."
Disadvantages of Lab Environments
Despite its advantages, the study's authors noted that the approach of studying cannabis efficacy in humans in a laboratory environment "may compromise ecological validity by introducing confounds that are germane to the subjective effects and acute behavioral and cognitive consequences of cannabis intoxication."
White-coat Effect Produces Anxiety
The researchers argued that laboratory environments may not align with real-world settings and may introduce a number of problems, including "stereotype threat, white-coat effects, acute loss of tolerance in novel environments, and exposure to unfamiliar cannabis chemovars," factors that could "inflate cognitive interference and anxiety."
"The researchers argued that laboratory environments may not align with real-world settings and may introduce a number of problems."
The study suggested that future cannabis researchers should employ a test environment that is "socially and clinically relevant to cannabis use." It described the white-coat effect, which is the potential influence of authority figures and a clinical laboratory settings on the behavior of the study participants and that this may "exacerbate cognitively impairing anxiety."
Novice vs. Regular Cannabis Users
The study explained how the distinct differences that exist between infrequent cannabis users and those who use it on a regular basis and the important role of tolerance in testing the efficacy of cannabis on humans. "Tolerance is most clearly reflected in clinically relevant areas such as cognition and anxiety," reported the scientists.
The research also noted the "diversity of cognitive effects" provided by different chemovars (strains or cultivars) of the cannabis plant and that this means that humans tested for their responses to cannabis in a laboratory environment "may produce distinct effects from the familiar, personally selected chemovars to which most users may be accustomed."
"In sum, several limitations associated with classic laboratory administration of cannabis to humans compromise the interpretation and extrapolation of findings and present substantial barriers to research," reported the study.
The Study
The study reviewed two prior studies that, together, involved 79 test subjects and employed the Naturalistic Cannabis Administration Protocol, whereby participants consumed their own cannabis at home and met with researchers via online video conferencing (Zoom). Results from these two studies was consolidated for ease of reporting and consumption. The research limited the consumption avenue employed by participants to inhalation (smoking or vaporization).
Of all participants, 62 percent reported cannabis use of "five or more days per week."
Of all participants, 62 percent reported cannabis use of "five or more days per week." The study reported that "most participants were familiar with the cannabis that they used and reported getting about as high as they would in a typical use session." The researchers strategically employed colloquial language, including "get as high as you would normally get," with the goal of "improving participant comfort and reducing stereotype threat."
Results
Interestingly, thirteen of the participants (17 percent of the cohort group) said that they would have been more comfortable "completing the session at the university laboratory" because of reasons that included "discomfort using cannabis in proximity to parents and distractions in their home environment."
The majority of study participants who preferred the home environment of the test noted their reasons for such being psychological and their lack of comfort "being high on campus or in a research lab." Most subjects also noted the physical comfort of being in their home environment, including mention of things such as "clothing, furniture, and blankets" typically not available in a laboratory setting.
Half of Subjects Preferred Home Testing
Overall, 55 percent of study participants reported their preference for the home environment testing and that they would have been "less comfortable completing the study in a laboratory."
The NCAP is a "low-barrier, ecologically valid paradigm to research the effects of cannabis use on human behavior."
The scientists determined that the results of the two human trials "demonstrated the feasibility and acceptability of a novel cannabis administration methodology." They proclaimed that the NCAP is a "low-barrier, ecologically valid paradigm to research the effects of cannabis use on human behavior."
NCAP Removes Barriers
The study reported that the NCAP procedure employed in both studies reviewed "reduces temporal, logistic, and financial barriers to conducting cannabis research by eliminating the need for researchers to apply for federal licenses to access, store, and subsequently destroy cannabis." This important technicality may allow future researchers to adopt the NCAP to more affordably and practically conduct valid scientific investigation into the efficacy of cannabis.
Conclusions
The study noted that previous research has demonstrated that approaches such as portable labs have addressed "the concern over the ecological validity of research-grade cannabis and lab-based drug administration approaches." It determined that its analysis of the NCAP identified it as a "practical evolution of previous work" and that the approach can meet scientific requirements present in standard laboratory settings "without unnecessarily burdening the participant."
Study participants "were more comfortable...in a familiar home environment versus a laboratory-based cannabis administration setting."
The researchers concluded that their results indicate that study participants "were more comfortable...in a familiar home environment versus a laboratory-based cannabis administration setting." They noted that the fact that the majority of participants preferred the home environment and their acceptance of the NCAP procedure have "important implications for future studies assessing the impacts of cannabis use on human behavior, cognition, emotion, and so forth."
The study summarized that adoption of the NCAP by future researchers may "reduce barriers for both researchers and participants and develop our research capabilities to fit the landscape of cannabis use today."
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