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Official websites use. Share sensitive information only on official, secure websites. Nicolas Schlienz and Tory Spindle completed the first draft of the manuscript in collaboration with Ryan Vandrey. Remaining authors contributed to the final draft of the manuscript by providing comments and feedback and all authors approve of the contents of the final manuscript. Prior controlled cannabis research has mostly focused on smoked cannabis and predominantly included frequent cannabis users. This study sought to characterize the pharmacodynamic effects of oral cannabis among infrequent cannabis users. Seventeen healthy adults who had not used cannabis for at least 60 days completed four experimental sessions in which they consumed a cannabis-infused brownie that contained 0, 10, 25, or 50 mg THC. The 25 and 50 mg THC doses elicited pronounced subjective effects and markedly impaired cognitive and psychomotor functioning compared with placebo. For all active doses, pharmacodynamic effects did not manifest until 30 — 60 min after ingestion, and peak effects occurred 1. Blood THC levels were significantly correlated with some pharmacodynamic drug effects, but were substantially lower than what is typically observed after cannabis inhalation. Ingestion of oral cannabis dose-dependently altered subjective drug effects and impaired cognitive performance. Unlike inhaled forms of cannabis for which acute effects occur almost immediately, effects of oral cannabis were considerably delayed. In an era of legalization, education about the time course of drug effects for cannabis edibles is needed to facilitate dose titration and reduce acute overdose incidents. Cannabis is one of the most widely used drugs in the world. Recent reforms to the policies governing the medicinal and non-medicinal i. Inhalation of smoked cannabis is the most common route of self-administration Borodovsky et al. However, the cannabis retail marketplace contains a vast array of products that can be administered via other routes Russell et al. Oral cannabis products a. This subset of cannabis products includes cannabis-infused food e. Cannabis edibles are perceived to be healthier than smoked cannabis and can be used discreetly, which increases their appeal Kostadinov and Roche, ; Lamy et al. Previous experimental examinations of the pharmacokinetic and pharmacodynamic effects of oral cannabis have typically administered pure THC, often in the form of dronabinol. These studies have shown that oral THC dose-dependently increases positive subjective drug effects ratings e. These studies also show dose-dependent impairment in attention, memory, and psychomotor performance following oral THC ingestion, but these effects are more consistently observed among less frequent cannabis users Curran et al. Though informative, these studies have limited ecological validity to current products available on the retail cannabis market. This is because most retail products are made with raw cannabis or whole-plant cannabis extracts and contain food ingredients that may affect drug absorption and alter pharmacodynamic effects relative to pharmaceutical formulations containing only THC e. Several of these studies Newmeyer et al. The fourth study, conducted in our laboratory, examined the acute effects of oral cannabis among participants who were randomly assigned to receive a single oral cannabis dose Vandrey et al. Collectively, these studies demonstrate that the acute pharmacodynamic effects of cannabis are substantially delayed following oral cannabis ingestion and often do not peak until several hours after administration, which is in stark contrast to inhaled forms of cannabis either smoked or vaporized for which cannabis effects peak within minutes Newmeyer et al. Regarding pharmacokinetic effects, peak concentrations of THC and its metabolites following oral cannabis ingestion are substantially lower compared with inhaled cannabis. The delayed onset of oral cannabis effects makes dose titration more difficult and increases the chances of acute overdose while the pharmacokinetics of oral cannabis make it difficult to identify individuals who are intoxicated based on blood THC concentrations alone Allen et al. There are some critical limitations of published laboratory studies involving controlled oral cannabis administration. First, most have only administered one or two doses, and as a result, the acute effects of oral cannabis have not been sufficiently characterized for the wide range of doses available in the retail marketplace Steigerwald et al. Participants in oral cannabis studies have included moderate to heavy users Newmeyer et al. Second, prior studies have included male participants predominantly. Last, oral cannabis products represent a growing portion of the market share of cannabis products, which necessitates further understanding of the physiologic, subjective, and cognitive effects of these products. The present study extends prior research by characterizing the pharmacodynamic effects of multiple oral cannabis doses 0, 10, 25, and 50 mg THC in a sample of infrequent cannabis users. The current study utilizes a within-subjects crossover design as opposed to the between-subjects design used in our prior oral cannabis study Vandrey et al. Study participants were healthy adults between the ages of 18 and 45 recruited via media advertisements and word-of-mouth. Age was verified with government-issued photo ID. Participants were nontreatment seeking and endorsed a history of lifetime exposure to cannabis but denied use of cannabis and other illicit drugs in the past three months. Participants completed a brief telephone screen and those deemed initially eligible were invited to complete a laboratory screening session. At the screening assessment, participants provided written informed consent and completed a series of semi-structured interviews and self-report questionnaires that collected basic demographic information and assessed mental health via DSM-IV Checklist for Adult Disorders , physical health, and history of recreational drug use. Participants were required to report no allergies to any of the ingredients used to prepare the cannabis brownies e. Participants were required to test negative via urinalysis for cannabinoid metabolites and recent illicit drug use. Participants also underwent a physical exam during which routine clinical chemistry, hematology, and serology were assessed and an electrocardiogram EKG was obtained to determine cardiovascular health participants who were deemed unhealthy based on results from any of these tests were not considered eligible for the study. A serum pregnancy test was also performed for females. At the end of the laboratory screening, participants completed training on subjective drug effect questionnaires and the computerized cognitive test battery to ensure task comprehension and to establish stable performance on the cognitive tasks. Participants completed four outpatient experimental laboratory visits, each lasting approximately 9 h, that were scheduled a minimum of one week apart to ensure sufficient elimination of cannabinoids between sessions. Upon arrival, participants were administered a breath alcohol test and provided a urine sample that was tested for recent illicit drug use and pregnancy for females only ; no positive tests occurred. All participants consumed a standard low-fat breakfast prior to the collection of baseline measures and cannabis exposure breakfast was consumed approximately 1 h prior to dosing. Participants were told that they would receive cannabis brownies containing either 10, 25, or 50 mg THC or placebo but that neither they, nor the research staff, would know what dose they received on a given day. Placebo cannabis, from which THC had been extracted using ethanol, was used to prepare placebo brownies; the same quantity of plant material was used in active and placebo conditions to assist with blinding. Following decarboxylation, cannabis plant material was mixed into the brownie batter. To ensure exact dosing, each dose was prepared separately in an individual baking tray. Prior to the study, sample brownies were made at each target THC dose 0, 10, 25, and 50 mg THC and these sample brownies were sent for analytical testing to a designated laboratory ElSohly Laboratories Inc. Results of this analytical testing confirmed the conversion of THC-A to THC and that the desired doses were reliably achieved in each product using our preparation procedures. Biological specimens, physiological measures, and subjective drug effects were assessed at baseline, 10 min after brownie consumption, and 0. Cognitive and psychomotor performance were also assessed at the same time points with the exception of the 10 min and 0. Vital signs i. Cognitive and psychomotor performance were assessed using three computerized tasks previously shown to be sensitive to acute cannabis intoxication Arkell et al. Performance on each of these tasks generalizes to the operation of a motor vehicle and functioning in the workplace. Using the computer mouse, participants tracked a central stimulus that moved horizontally from side to side while simultaneously monitoring a target digit that appeared in the lower portion of the screen. Peripheral stimuli single digit integers appeared in each of the four corners of the screen and participants had to click the computer mouse during each instance when the digits in the corners of the screen matched the central target digit. Primary outcomes for the DAT were the total number of correctly identified peripheral targets, mean correct peripheral target reaction time milliseconds , and average distance number of pixels of the cursor from the central horizontal stimulus. Psychomotor performance was assessed with a computerized version of the Digit Symbol Substitution Task DSST that required participants to replicate a geometric pattern that was displayed on the monitor using the computer keyboard McLeod et al. Primary outcomes for the DSST were the total number of trials attempted, total number of correct trials, and the percentage of attempted trials that were completed correctly. During this task, a string of single-digit integers were displayed sequentially on the computer monitor. Participants were instructed to calculate the sum of each successive integer pair and choose the correct answer from a list of choices displayed on the screen. Primary outcomes for the PASAT were the number of correct trials and mean reaction time milliseconds during correct trials. During each visit, participants consumed one cannabis-containing brownie that had 1 of 4 possible THC doses 0, 10, 25, or 50 mg. They were instructed to consume the entire brownie within five minutes and were under direct staff observation during this time. Participants were permitted to drink water only as needed and were not permitted to consume any snack items for 30 min post-ingestion to minimize potential differences in absorption across participants. Drug administration was double-blind and dose order was counterbalanced and randomly assigned across study participants. Demographic characteristics and whole blood THC data were summarized using descriptive statistics including means and standard deviations. Separate regressions were performed for each outcome and 3 factors were included in each model: time, dose, and participant sex. A first-order autoregressive AR 1 covariance structure was used for these analyses. Planned contrasts were conducted to compare mean peak scores between placebo 0 mg to each active dose 10, 25, and 50 mg for each outcome. Participant characteristics are displayed in Table 1. Table 2 shows mean SD peak scores for pharmacodynamic outcomes in each dosing condition. Two adverse events occurred in this study. One participant vomited following consumption of the 50 mg THC cannabis brownie and another vomited in the 25 mg THC condition both participants vomited approximately 3 h after drug administration. In both instances, emesis was brief and immediately resolved feelings of nausea. However, there were no Sex x Dose interactions for cardiovascular outcomes. However, no Sex x Dose interactions were observed for subjective outcomes. For the DAT Fig. No significant Sex x Dose interactions were observed. Detailed understanding of the pharmacodynamic dose effects of oral cannabis is vital given the increasing popularity of these products in the expanding legal cannabis market. Most prior controlled cannabis research studies have examined the acute effects of smoked cannabis in frequent cannabis users. The present study utilized a within-subjects design to characterize the pharmacodynamic profile of four doses of oral cannabis i. Overall, ingestion of oral cannabis resulted in dose-dependent effects in attention, memory, and psychomotor performance. The 10 mg dose did not produce performance deficits relative to placebo. However, the 25 and 50 mg doses produced moderate to severe impairment on all performance measures included in this study when compared with placebo. These findings are noteworthy because the THC doses administered in this study are representative of common doses found in commercially-available oral cannabis products. Medicinal or non-medical i. Consistent with prior controlled oral cannabis research, pharmacodynamic cannabis effects were substantially delayed in this study compared to what is typically observed following cannabis inhalation Newmeyer et al. For example, on average, subjective drug effects became perceptible 30 min after brownie ingestion and peaked 1. Effects on cognitive and psychomotor performance followed a similar pattern, as peak impairment on cognitive measures were detected between 2 — 5 hours post-administration, depending on the task and dose. In contrast, peak subjective and cognitive effects of inhaled cannabis occur within 10 — 30 min of inhalation Newmeyer et al. Despite differences in the onset of effects, the magnitude of cognitive impairment observed in this study was comparable to that observed following inhalation of similar doses of smoked or vaporized cannabis. For example, ingestion of the 25 mg oral cannabis dose in this study decreased the number of correct responses on the PASAT by 18 on average, while the same dose 25 mg THC of smoked and vaporized cannabis reduced correct PASAT responses by an average of 16 and 22, respectively, in a recent study Spindle et al. Taken together, these findings highlight why oral cannabis products are at high risk for eliciting accidental acute overdose, particularly among infrequent users Barrus et al. Consumers of cannabis products, as well as cannabis vendors, should be aware of the delayed onset of effects for oral cannabis and difficulties with dose titration. This knowledge is particularly important for novice users, who may be most at risk for acute overdose from oral cannabis products. Despite the significant correlations observed between blood cannabinoid levels and cognitive performance, blood THC concentrations in this study were far lower than peak concentrations observed after cannabis inhalation in prior studies Fabritius et al. Differences in blood THC concentrations between oral and inhaled cannabis may stem from orally-ingested THC undergoing first pass metabolism which does not occur when THC is inhaled \[ for review see: Huestis, \], and also the fact that oral ingestion results in a slower rate of absorption which can result in lower systemic concentrations in the blood that may not reflect concentrations in the brain and other tissues. Indeed, despite the 25 and 50 mg THC doses producing marked impairment, mean peak blood THC concentrations were only 2. These are near or below per se quantitative THC cutoffs often used by law enforcement to detect impaired drivers. For example, some users displayed impaired performance after ingestion of the 10mg THC dose, even though, on average, this dose did not alter performance relative to placebo. In a similar vein, some users displayed little to no impairment following ingestion of the highest dose 50 mg THC , which produced drastic alterations in performance in the majority of participantsparticipant. Sex differences i. However, we were likely underpowered to detect such interactions given the relatively small sample size i. Additional controlled research, with larger sample sizes, is needed to identify individual-level factors e. Further exploration of potential sex differences on pharmacodynamic outcomes following oral cannabis dosing is particularly important, given that prior studies have found that women exhibit greater sensitivity to acute effects from smoked cannabis compared to men Cooper and Haney, This study had several limitations. Second, though we were adequately powered for detecting dose effects using within-subjects comparisons, our sample size was underpowered to test for individual-level participant characteristics e. Thus, additional research is needed to evaluate between-subjects characteristics such as sex, prior experience with cannabis use, genetics, and other factors that may differentiate the acute pharmacodynamic response to oral cannabis. Third, this study was conducted in a controlled laboratory setting which may limit the generality of our findings to drug effects that may be influenced by physical or social context. In conclusion, the present study characterized pharmacodynamic drug effects following consumption of oral cannabis in a sample of infrequent cannabis users; results indicated that pharmacodynamic effects were altered in a dose-dependent manner. That is, the smallest active cannabis dose administered 10 mg THC produced discriminable drug effects and elevated heart rate relative to placebo but did not alter performance on a battery of cognitive and psychomotor tests. Conversely, the two highest oral cannabis doses administered 25 and 50 mg THC produced substantial subjective drug effects and markedly impaired cognitive and psychomotor functioning. These acute cannabis effects often did not peak until several hours after dose administration, which stands in stark contrast to inhaled forms of cannabis where such effects occur almost immediately. Novice users should be educated about how to avoid acute overdose from cannabis edibles. In particular, knowledge regarding the delayed onset of effects for oral cannabis products should be widely disseminated in locations where cannabis can be purchased legally. We thank the support staff of the Johns Hopkins University Behavioral Pharmacology Research Unit for outstanding contributions to the implementation of this study. We also thank Dr. Christine Moore and Ms. Cynthia Coulter at Immunalysis Inc. The remaining authors have no conflicts of interest to declare. As a library, NLM provides access to scientific literature. Drug Alcohol Depend. Published before final editing as: Drug Alcohol Depend. Find articles by Nicolas J Schlienz. Find articles by Tory R Spindle. Find articles by Edward J Cone. Find articles by Evan S Herrmann. Find articles by George E Bigelow. Find articles by John M Mitchell. Find articles by Ronald Flegel. Find articles by Charles LoDico. Find articles by Ryan Vandrey. Contributors Nicolas Schlienz and Tory Spindle completed the first draft of the manuscript in collaboration with Ryan Vandrey. PMC Copyright notice. The publisher's version of this article is available at Drug Alcohol Depend. Open in a new tab. Declaration of Competing Interest Dr. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel.

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