Dataset Information

A Clinical Framework for Evaluating Cannabis Product Quality and Safety.

ABSTRACT: Increase in medical cannabis use, along with available products, warrants the need for clinicians to be knowledgeable in evaluating the quality of any cannabis product presented in clinical practice. Determining whether a product is regulated within the region is key in assessing overall quality and safety. Regulated products are held to a higher standard including independent testing, contamination mitigation, and concentration limits. Here, we present a clinical framework in evaluating cannabis products to ascertain the quality and regulation level of the product. Evaluation includes assessing the source company, reviewing product details (e.g., type, cannabinoid content, and labeling), and assessing quality control variables such as manufacturing and decontamination processes. The quality of products patients use is an important part of mitigating cannabis-related harms, especially in medically vulnerable patients. Currently, there is a great need to implement widespread standardization and regulations to ensure product quality and safety.

SUBMITTER: MacCallum CA

PROVIDER: S-EPMC10249738 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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A Clinical Framework for Evaluating Cannabis Product Quality and Safety.

MacCallum Caroline A CA Lo Lindsay A LA Pistawka Carly A CA Boivin Michael M

Cannabis and cannabinoid research 20220118 3

Increase in medical cannabis use, along with available products, warrants the need for clinicians to be knowledgeable in evaluating the quality of any cannabis product presented in clinical practice. Determining whether a product is regulated within the region is key in assessing overall quality and safety. Regulated products are held to a higher standard including independent testing, contamination mitigation, and concentration limits. Here, we present a clinical framework in evaluating cannabi ...[more]

PMID: 35049330

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Project description:ObjectiveAbstinence is rarely achieved in clinical trials for cannabis use disorder (CUD). Cannabis reduction is associated with functional improvement, but reduction endpoints have not been established, indicating a need to identify and validate clinically meaningful reduction endpoints for assessing treatment efficacy.MethodData from a 12-week double-blind randomized placebo-controlled medication trial for cannabis cessation (NCT01675661) were analyzed. Participants (N = 225) were treatment-seeking adults, M = 30.6 (8.9) years old, 70.2% male, and 42.2% Non-White, with CUD who completed 12 weeks of treatment. Frequency (days of use per week) and quantity (grams per using day) were used to define high-, medium-, and low-risk levels. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale and cannabis-related problems were assessed using the Marijuana Problems Scale. General linear models for repeated measures tested associations between the magnitude of risk reduction and functional outcomes from baseline (BL) to end-of-treatment (EOT).ResultsCannabis risk levels were sensitive to reductions in use from BL to EOT for frequency- (χ² = 19.35, p = .004) and quantity-based (χ² = 52.06, p < .001) metrics. Magnitude reduction in frequency-based risk level was associated with magnitude decrease in depression (F = 2.76, p = .043, ηp² = .04), anxiety (F = 3.70, p = .013, ηp² = .05), and cannabis-related problems (F = 8.95, p < .001, ηp² = .12). Magnitude reduction in quantity-based risk level was associated with magnitude decrease in anxiety (F = 3.02, p = .031, ηp² = .04) and cannabis-related problems (F = 3.24, p = .023, ηp² = .05).ConclusionsCannabis use risk levels, as operationalized in this study, captured reductions in use during a clinical trial. Risk level reduction was associated with functional improvement suggesting that identifying risk levels and measuring the change in levels over time may be a viable and clinically meaningful endpoint for determining treatment efficacy. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Project description:ImportanceExpanding cannabis medicalization and legalization increases the urgency to understand the factors associated with acute driving impairment.ObjectiveTo determine, in a large sample of regular cannabis users, the magnitude and time course of driving impairment produced by smoked cannabis of different Δ9-tetrahydrocannabinol (THC) content, the effects of use history, and concordance between perceived impairment and observed performance.Design, setting, and participantsThis double-blind, placebo-controlled parallel randomized clinical trial took place from February 2017 to June 2019 at the Center for Medicinal Cannabis Research, University of California San Diego. Cannabis users were recruited for this study, and analysis took place between April 2020 and September 2021.InterventionsPlacebo or 5.9% or 13.4% THC cannabis smoked ad libitum.Main outcomes and measuresThe primary end point was the Composite Drive Score (CDS), which comprised key driving simulator variables, assessed prior to smoking and at multiple time points postsmoking. Additional measures included self-perceptions of driving impairment and cannabis use history.ResultsOf 191 cannabis users, 118 (61.8%) were male, the mean (SD) age was 29.9 (8.3) years, and the mean (SD) days of use in the past month was 16.7 (9.8). Participants were randomized to the placebo group (63 [33.0%]), 5.9% THC (66 [34.6%]), and 13.4% THC (62 [32.5%]). Compared with placebo, the THC group significantly declined on the Composite Drive Score at 30 minutes (Cohen d = 0.59 [95% CI, 0.28-0.90]; P < .001) and 1 hour 30 minutes (Cohen d = 0.55 [95% CI, 0.24-0.86]; P < .001), with borderline differences at 3 hours 30 minutes (Cohen d = 0.29 [95% CI, -0.02 to 0.60]; P = .07) and no differences at 4 hours 30 minutes (Cohen d = -0.03 [95% CI, -0.33 to 0.28]; P = .87). The Composite Drive Score did not differ based on THC content (likelihood ratio χ24 = 3.83; P = .43) or use intensity (quantity × frequency) in the past 6 months (likelihood ratio χ24 = 1.41; P = .49), despite postsmoking blood THC concentrations being higher in those with the highest use intensity. Although there was hesitancy to drive immediately postsmoking, increasing numbers (81 [68.6%]) of participants reported readiness to drive at 1 hour 30 minutes despite performance not improving from initial postsmoking levels.Conclusions and relevanceSmoking cannabis ad libitum by regular users resulted in simulated driving decrements. However, when experienced users control their own intake, driving impairment cannot be inferred based on THC content of the cigarette, behavioral tolerance, or THC blood concentrations. Participants' increasing willingness to drive at 1 hour 30 minutes may indicate a false sense of driving safety. Worse driving performance is evident for several hours postsmoking in many users but appears to resolve by 4 hours 30 minutes in most individuals. Further research is needed on the impact of individual biologic differences, cannabis use history, and administration methods on driving performance.Trial registrationClinicalTrials.gov Identifier: NCT02849587.

Dataset Information

A Clinical Framework for Evaluating Cannabis Product Quality and Safety.

Publications

A Clinical Framework for Evaluating Cannabis Product Quality and Safety.

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