Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.
Centre for Interdisciplinary Addiction Research, Department of Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
F1000Res. 2020 Mar 23;9:201. doi: 10.12688/f1000research.22612.2. eCollection 2020.
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. 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. 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. German Clinical Trials Register (DRKS), DRKS00020829.
需要新的方法来减缓或扭转德国 delta-9-四氢大麻酚 (THC) 水平和与大麻相关的住院治疗呈上升趋势的情况。合法获得大麻可能是一种可行的有效政策应对措施；然而，现有的证据不足以为德国的监管模式提供信息。拟议的研究旨在通过药房合法提供草药大麻来减少大麻使用者的伤害。一项比较有合法途径获取草药大麻的大麻使用者（柏林，干预组）和没有合法途径的大麻使用者（汉堡，对照组）（总 N=698）的准实验研究。作为主要结果，我们假设：1）干预组中非法 THC 消费将减少至少 50%，2）干预组的总 THC 暴露量将比对照组至少减少 10%，考虑到基线值。次要结果包括使用频率、THC 损害驾驶和给药方式的测量。将进行配对 t 检验和多层回归模型进行统计分析。 本研究提案目前正在由负责批准包括大麻在内的分类物质研究的“联邦药物和医疗器械研究所”进行审查。在获得批准并开始研究之前，将进行全面的伦理审查。研究结果可能为德国和其他司法管辖区的监管模式提供信息，并有望加深对合法获取大麻影响的理解。 德国临床试验注册处 (DRKS)，DRKS00020829。
