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

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Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users - a quasi-experimental study in Germany. / Manthey, Jakob; Kalke, Jens; Rehm, Jürgen; Rosenkranz, Moritz; Verthein, Uwe.

in: F1000 Research, Jahrgang 9, 2020, S. 201.

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@article{bb1bbe66eb784355aa418739594b4a9b,
title = "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.",
author = "Jakob Manthey and Jens Kalke and J{\"u}rgen Rehm and Moritz Rosenkranz and Uwe Verthein",
note = "Copyright: {\textcopyright} 2020 Manthey J et al.",
year = "2020",
doi = "10.12688/f1000research.22612.2",
language = "English",
volume = "9",
pages = "201",

}

RIS

TY - JOUR

T1 - Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users - a quasi-experimental study in Germany

AU - Manthey, Jakob

AU - Kalke, Jens

AU - Rehm, Jürgen

AU - Rosenkranz, Moritz

AU - Verthein, Uwe

N1 - Copyright: © 2020 Manthey J et al.

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

U2 - 10.12688/f1000research.22612.2

DO - 10.12688/f1000research.22612.2

M3 - SCORING: Journal article

C2 - 32789008

VL - 9

SP - 201

ER -