TY  - JOUR
PY  - 2020//
TI  - Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany
JO  - F1000Research
A1  - Manthey, Jakob
A1  - Kalke, Jens
A1  - Rehm, Jürgen
A1  - Rosenkranz, Moritz
A1  - Verthein, Uwe
SP  - e201
EP  - e201
VL  - 9
IS  - 
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. <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>
LA  - en
SN  - 2046-1402
UR  - http://dx.doi.org/10.12688/f1000research.22612.2
ID  - ref1
ER  -