RESUMO
INTRODUCTION: The medical use of cannabinoids is limited mainly by their undesirable effects. With respect to acute psychotropic effects, the aim of this study is the comparison of an oral cannabis extract and low-dose diazepam in a cross-over experiment in drug-naïve healthy women. METHODS: Sixteen healthy females participated in this randomized, double-blind, active comparator-controlled, single-dose, balanced 2-way cross-over study. Cannabis extract with standardised Delta (9)-tetrahydrocannabinol (THC) content (20 mg) or active placebo (5 mg diazepam) was administered orally. Subjects were assessed by self- and observer-rated visual analogue scales (VAS), the BRIEF PSYCHIATRIC RATING SCALE (BPRS) and three psychomotor tests up to 6 h after administration. RESULTS: VAS showed significantly elevated fatigue, drowsiness, dizziness, and "feeling high" after cannabis as compared to baseline and diazepam. BPRS scores were significantly higher after cannabis intake. Only in one psychomotor test a decrease of psychomotor activity after cannabis was evident. One subject in the cannabis condition experienced severe transient psychotic symptoms. DISCUSSION: Orally administered cannabis produced significant central depressant side-effects compared to diazepam, mostly subjective effects (VAS) but marginal effects in psychomotor performance in 15 healthy females. Regarding the medical use of cannabis, a rigorous benefit-risk analysis and an exact psychiatric assessment before and during treatment are necessary.
Assuntos
Cannabis/química , Dronabinol/efeitos adversos , Transtornos Psicóticos/etiologia , Administração Oral , Adulto , Análise de Variância , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Medição da Dor , Escalas de Graduação Psiquiátrica , Psicometria/métodos , Desempenho Psicomotor/efeitos dos fármacos , Autoimagem , Fatores de Tempo , Adulto JovemRESUMO
Major contributions to the investigation of the influence of drugs on driving ability come from experimental studies as apart from epidemiological studies. Regarding experimental studies, the results of a single study are essentially determined by the experimental design. An established assessment of the risk of a drug in regard to driving ability should not be based on either a single study or on synopses, which record only a few studies without detailed information. This article presents an overview of published studies that directly or indirectly deal with the influence of flunitrazepam on driving ability. Benzodiazepines in particular, and amongst these especially flunitrazepam are brought into connection with the impairment of driving ability. This approach emphasises differences regarding the dosages used, the experimental designs and the methods of testing. For reasons of clarity the article on flunitrazepam is subdivided into the topics of acute effects, residual effects, and effects after subchronic application. Different results are reported. A statistical analysis in terms of a meta-analysis was not carried out due to a lack of standardization of the studies.