{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:09:25Z","timestamp":1772168965610,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/f1000research.22612.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T00:00:00Z","timestamp":1601942400000}}],"reference-count":61,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T00:00:00Z","timestamp":1601942400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Federal state of Berlin","award":["GES\/2018\/P 412"],"award-info":[{"award-number":["GES\/2018\/P 412"]}]}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"<ns4:p>\n                    <ns4:bold>Background:<\/ns4:bold>\n                    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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Protocol:<\/ns4:bold>\n                    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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Discussion:<\/ns4:bold>\n                    This study proposal is currently being reviewed by the \u2018Federal Institute for Drugs and Medical Devices\u2019 \u2013 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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Pre-registration:<\/ns4:bold>\n                    German Clinical Trials Register (DRKS), DRKS00020829\n                  <\/ns4:p>","DOI":"10.12688\/f1000research.22612.2","type":"journal-article","created":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T11:05:06Z","timestamp":1601982306000},"page":"201","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Controlled administration of cannabis to mitigate cannabis-attributable harm among recreational users: a quasi-experimental study in Germany"],"prefix":"10.12688","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1231-3760","authenticated-orcid":false,"given":"Jakob","family":"Manthey","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens","family":"Kalke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5665-0385","authenticated-orcid":false,"given":"J\u00fcrgen","family":"Rehm","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0851-6330","authenticated-orcid":false,"given":"Moritz","family":"Rosenkranz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uwe","family":"Verthein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2020,10,6]]},"reference":[{"key":"ref-1","article-title":"World Drug Report 2018","year":"2018"},{"key":"ref-2","article-title":"European Drug Report 2019: Trends and Developments","year":"2019"},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"93-96","DOI":"10.1016\/j.drugpo.2019.03.006","article-title":"Cannabis use in Europe: Current trends and public health concerns.","volume":"68","author":"J Manthey","year":"2019","journal-title":"Int J Drug Policy."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"1015-1023","DOI":"10.1111\/add.14525","article-title":"Increasing potency and price of cannabis in Europe, 2006\u201316.","volume":"114","author":"T Freeman","year":"2019","journal-title":"Addiction."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"585-591","DOI":"10.3238\/arztebl.2019.0585","article-title":"Trends In Substance Use And Related Disorders.","volume":"116","author":"N Seitz","year":"2019","journal-title":"Dtsch Arztebl Int."},{"key":"ref-6","article-title":"Statistical Bulletin 2019 \u2014 Price, purity and potency.","year":"2019"},{"key":"ref-7","article-title":"Statistical Bulletin 2019 \u2014 Drug law offences.","year":"2019"},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"3181-89","DOI":"10.1017\/S0033291715001178","article-title":"Examining the profile of high-potency cannabis and its association with severity of cannabis dependence.","volume":"45","author":"T Freeman","year":"2015","journal-title":"Psychol Med."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"62-74","DOI":"10.1007\/s40429-017-0142-2","article-title":"Does Cannabis Composition Matter? 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However, we belief that the vast majority of study participants agreeing to participate in the study, will do so because of their internal motivation in supporting this research. The 25\u20ac compensation will only serve to ensure high rates of follow-up. For the control group, we decided not to provide any compensation, as this could be perceived as incentive to buy (and use) cannabis legally. Prior to conducting primary and secondary outcome analyses, we will compare user characteristics (socio-economic variables and cannabis use indicators) of both groups and will take them into account in all analyses, if applicable. Regarding the assessment of THC exposure: We have added some details on the assessment of the primary outcome to the text. In both groups, we will collect usual consumption units to determine the THC level per use occasion for baseline and 12 months follow-up. For the intervention group, the THC exposure at follow-up will be determined by triangulating baseline data (i.e. from illegally acquired cannabis), sales data, as well as questionnaire data. This will allow to calculate the proportion of total THC consumption attributable to illegally acquired cannabis and thus lay the foundation for the primary outcome analyses.","URL":"https:\/\/f1000research.com\/articles\/9-201\/v2#referee-comment-5848","order":1,"name":"referee-comment-5848","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.24962.r67190, Josefine Atzendorf, Munich Center for the Economics of Aging (MEA), Max Planck Institute for Social Law and Social Policy, Munich, Germany, 03 Aug 2020, version 1, indexed","URL":"https:\/\/f1000research.com\/articles\/9-201\/v1#referee-response-67190","order":2,"name":"referee-response-67190","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Jakob Manthey<\/b>; <i>Posted: 24 Aug 2020<\/i>; In order to facilitate understanding of the assessment of the primary outcome (THC exposure), we have added the following half-sentence in the respective section:Second, questionnaire data will be used to determine the number of use occasions within the past 30 days <b>, separately for legally and illegally acquired cannabis<\/b>.THC exposure will thus be quantified for illegally and legally acquired cannabis for the intervention group as this is a prerequisite for analysing the primary outcome.","URL":"https:\/\/f1000research.com\/articles\/9-201\/v2#referee-comment-5849","order":3,"name":"referee-comment-5849","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by the federal state of Berlin (Germany) [GES\/2018\/P 412]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}