Dataset Information

Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany.

ABSTRACT: Background: New approaches are required to slow down or reverse increasing trends of levels of delta-9-tetrahydrocannabinol (THC) and cannabis-attributable hospitalizations in Germany. Legal access to cannabis may constitute one viable effective policy response; however, available evidence does not suffice to inform a regulation model for Germany. The proposed study aims to reduce harm for cannabis users through legal access to herbal cannabis through pharmacies. Protocol: A quasi-experimental study comparing cannabis users with legal access to herbal cannabis (Berlin, intervention group) to those without legal access (Hamburg, control group) (total N=698). As the primary outcome, we hypothesize that: 1) illegal THC consumption will reduce by at least 50% in the intervention group and 2) total THC exposure in the intervention group will be reduced by at least 10% lower than that of the control group, taking into account baseline values. Secondary outcomes comprise measures of frequency of use, THC-impaired driving, and mode of administration. Paired t-tests and multilevel regression models will be performed for statistical analyses. Discussion: This study proposal is currently being reviewed by the 'Federal Institute for Drugs and Medical Devices' - the body responsible for approving research studies on classified substances, including cannabis. Upon approval and prior to the start of the study, a full ethical review will be undertaken. Results may inform a regulation model for Germany and other jurisdictions and are expected to deepen the understanding of the effects of legal access to cannabis. Pre-registration: German Clinical Trials Register (DRKS), DRKS00020829.

SUBMITTER: Manthey J

PROVIDER: S-EPMC7400698 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany.

Manthey Jakob J Kalke Jens J Rehm Jürgen J Rosenkranz Moritz M Verthein Uwe U

F1000Research 20200323

<b>Background:</b> New approaches are required to slow down or reverse increasing trends of levels of delta-9-tetrahydrocannabinol (THC) and cannabis-attributable hospitalizations in Germany. Legal access to cannabis may constitute one viable effective policy response; however, available evidence does not suffice to inform a regulation model for Germany. The proposed study aims to reduce harm for cannabis users through legal access to herbal cannabis through pharmacies. <b>Protocol:</b> A quasi- ...[more]

PMID: 32789008

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Project description:BackgroundLebanon remains as one of the major sources of cannabis worldwide. In 2020, its government passed a legislation enabling the cultivation of local medicinal cannabis. This first study following the legislative change examines the overlapping use of cannabis for recreational/medicinal purposes and characteristics of the distinct cannabis user types.MethodsA total of 1230 young adults (18-24 years) filled an anonymous online survey in early 2020.ResultsYoung adults in the sample were distributed as follows: 33% 18-20 years; 60% males; 94% Lebanese; 75% students; and 89% living with family. The older young adults (21-24), males, those employed, living with non-family members, and who perceived themselves as being a little/lot richer than most were statistically significantly more present in the cannabis user subtypes (recreational only or recreational/medicinal) than non-cannabis users. When dual recreational/medicinal users are compared to recreational users only, the latter seemed to have a more conservative profile of behaviours, attitudes, and perceptions and acts of harm. The prevalence ratio comparing the prevalence of users supporting consuming cannabis "once or twice" in dual motive users vs. recreational users only was 1.13 for "once or twice", 1.25 for "occasionally", 1.64 for "regularly", and 2.4 for "daily". Any other illicit drug use was reported by 1% of the non-cannabis users, 36% of the recreational users only, and 58% of the recreational/medicinal users (p-value < 0.01). Similarly, any prescription drug use was reported by 3% of the non-cannabis users, 16% of the recreational users only, and 28% of both recreational/medicinal users (p-value < 0.01).ConclusionThe interface between recreational and medicinal cannabis use is complex. Dual motive users may warrant special attention as a subpopulation of cannabis users. This is relevant to contexts experiencing medicinal cannabis legislation changes, such as Lebanon, as policymakers and implementers should be sensitized to the emerging evidence for more data-informed policy changes.

Project description:BackgroundWith the legalization of cannabis in Canada, young adults, who are already at risk of automobile crashes, may increase their use of cannabis, which may further increase the risk of crashes. We examined the effects of inhaled cannabis on driving-related performance in healthy 18- to 24-year-old recreational cannabis users.MethodsIn this within-subject randomized study, participants completed tests in the no-cannabis state and at 1, 3 and 5 hours after inhalation of a standard 100-mg dose of cannabis. We then measured performance (in useful-field-of-view and driving-simulation tests) and self-reported perceptions (driving ability and safety, cannabis effects). Repeated-measures analysis of variance (for cannabis effects on continuous performance measures), Cochran Q tests (for performance-related crash risk and binary complex simulator task scores) and correlational analyses (for self-reported perceptions relative to performance) were employed.ResultsForty-five participants completed all 180 testing sessions. Significant effects of cannabis (relative to no cannabis) were noted on complex useful-field-of-view tasks at 3 hours (complex divided-attention task: 70 ± 24 ms v. 37 ± 12 ms, 95% confidence intervals [CIs] 28-114 ms v. 29-45 ms, t = -2.98, df = 41, p = 0.005; complex selective-attention task: 102 ± 66 ms v. 64 ± 18 ms, 95% CIs 60-144 ms v. 53-75 ms, t = -2.42, df = 41, p = 0.02) and 5 hours (complex selective-attention task: 82 ± 29 ms v. 61 ± 19 ms, 95% CIs 62-100 ms v. 48-75 ms, t = -2.32, df = 41, p = 0.03) after cannabis use when the tasks were novel (performed in a cannabis state at the first session). Participants were significantly more likely to be classified as having a high crash risk (on the basis of simulator tasks) after cannabis use (χ 2 = 13.23, df = 1, p < 0.001, odds ratio 4.31, 95% CI 0.41-45.2) and reported significantly lower perceived driving ability and safety after cannabis use relative to non-use.InterpretationAmong young recreational cannabis users, a 100-mg dose of cannabis by inhalation had no effect on simple driving-related tasks, but there was significant impairment on complex tasks, especially when these were novel. These effects, along with lower self-perceived driving ability and safety, lasted up to 5 hours after use.Trial registrationThe trial was registered with Health Canada (NOL [No Objection Letter] no. 215101).

Project description:Traditionally, smoking has been the predominant method for administering cannabis, but alternative routes of administration have become more prevalent. Additionally, research examining urinary cannabinoid excretion profiles has primarily focused on 11-nor-9-carboxy-∆9-tetrahydrocannabinol (∆9-THC-COOH), a metabolite of ∆9-tetrahydrocannabinol (∆9-THC), as the primary analyte. The aim of the current study was to characterize the urinary excretion profile of ∆9-THC-COOH, ∆9-THC, ∆8-tetrahydrocannabinol (∆8-THC), 11-hydroxy-∆9-tetrahydrocannabinol (11-OH-∆9-THC), ∆9-tetrahydrocannabivarin (THCV), 11-nor-∆9-tetrahydrocannabivarin-9-carboxlic acid (THCV-COOH), cannabidiol (CBD), cannabinol (CBN) and 8,11-dihydroxytetrahydrocannabinol (8,11-diOH-∆9-THC) following controlled administration of both oral and vaporized cannabis. Participants (n = 21, 11 men/10 women) who were infrequent cannabis users ingested cannabis-containing brownies (0, 10 and 25 mg ∆9-THC) and inhaled vaporized cannabis (0, 5 and 20 mg ∆9-THC) across six double-blind outpatient sessions. Urinary concentrations of ∆9-THC analytes were measured at baseline and for 8 h after cannabis administration. Sensitivity, specificity and agreement between the three immunoassays (IAs) for ∆9-THC-COOH (cutoffs of 20, 50 and 100 ng/mL) and liquid chromatography-tandem mass spectrometry (LC-MS-MS) analyses (confirmatory cutoff concentrations of 15 ng/mL) were assessed. Urinary concentrations for ∆9-THC-COOH, ∆9-THC, 11-OH-∆9-THC, THCV, CBN and 8,11-diOH-∆9-THC all peaked at 5-6 h and 4 h following oral and vaporized cannabis administration, respectively. At each active dose, median maximum concentrations (Cmax) for detected analytes were quantitatively higher after oral cannabis administration compared to vaporized. Using current recommended federal workplace drug-testing criteria (screening via IA with a cutoff of ≥50 ng/mL and confirmation via LC-MS-MS at a cutoff of ≥15 ng/mL), urine specimens tested positive for ∆9-THC-COOH in 97.6% of oral sessions and 59.5% of vaporized sessions with active ∆9-THC doses. These data indicate that while ∆9-THC-COOH may serve as the most consistent confirmatory analyte under the current drug-testing guidelines, future work examining 11-OH-∆9-THC under similar parameters could yield an alternative analyte that may be helpful in distinguishing between licit and illicit cannabis products.

Dataset Information

Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany.

Publications

Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany.

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