@article{ref1,
title="Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany",
journal="F1000Research",
year="2020",
author="Manthey, Jakob and Kalke, Jens and Rehm, Jürgen and Rosenkranz, Moritz and Verthein, Uwe",
volume="9",
number="",
pages="e201-e201",
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. <br><br>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. <br><br>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.<p /> <p>Language: en</p>",
language="en",
issn="2046-1402",
doi="10.12688/f1000research.22612.2",
url="http://dx.doi.org/10.12688/f1000research.22612.2"
}