RESUMO
The aim of this prospective, placebo-controlled, double-blind, randomized, cross-over study was to determine cannabinoid levels in blood and driving-related ability after single (S1) and repetitive (S2) vaporization of cannabis rich in cannabidiol (CBD) containing < 1% Δ9-etrahydrocannabinol (THC). Healthy adult volunteers (Nsingle = 27, Nrepetitive = 20) with experience in smoking vapor-inhaled two low-THC/CBD-rich cannabis products both with < 1% THC (product 1: 38 mg CBD, 1.8 mg THC; product 2: 39 mg CBD, 0.6 mg THC) and placebo. Main outcomes were THC- and CBD-levels in whole blood and overall assessment of driving-related ability by computerized tests. Among 74 participants included, 27 (mean age ± SD, 28.9 ± 12.5 years) completed S1, and 20 (25.2 ± 4.0) completed S2. Peak concentrations and duration of detectability depended on the THC-content of the product. After single consumption THC dropped below 1.5 µg/L after 1.5 h, but was detected in some participants up to 5 h. Pairwise comparison of driving-related ability revealed no significant differences between low-THC/CBD-rich products (P1, P2) and placebo. Detection of THC after consumption of low-THC/CBD-rich cannabis might have legal consequences for drivers. Regarding overall driving-related ability, no significant differences were observed between the interventional products. This trial was registered with the German Clinical Trials Register (DRKS00018836) on 25.10.2019 and with the Coordination Office for Human Research (kofam) which is operated by the Federal Office of Public Health (FOPH) (SNCTP000003294).
RESUMO
AIM: Ultrahigh risk (UHR) criteria, consisting of brief limited intermittent psychotic symptoms (BLIPS), attenuated psychotic symptoms (APS) and genetic risk and deterioration (GRD) syndrome are the most widely used criteria for assessing the clinical high-risk state for psychosis (CHR-P). The Basel Screening Instrument for Psychosis (BSIP) includes a further risk category, the unspecific risk category (URC). However, little is known about the predictive power of this risk category compared to other risk categories. METHODS: Two hundred CHR-P patients were detected as part of the Früherkennung von Psychosen (FePsy) study using the BSIP. Transition to psychosis was assessed in regular intervals for up to 7 years. RESULTS: Patients meeting only the URC criterion (n = 40) had a significantly lower risk of transition to psychosis than the UHR group (including BLIPS, APS and GRD) (HR 0.19 [0.05; 0.80] (P = 0.024). Furthermore, the URC only risk group had a lower transition risk than the APS without BLIPS group (P = 0.015) and a trendwise lower risk than the BLIPS group (P = 0.066). However, despite the lower transition risk in the URC only group, there were still two patients (5%) in this group with a later transition to psychosis. CONCLUSIONS: The URC includes patients who have a lower risk of transition than those included by the UHR categories and thereby increases the sensitivity of the BSIP. This offers the possibility of a stratified intervention, with these subjects receiving low intensity follow-up and treatment.