Finding studies
Finding studies
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Lead
Kontigo Care AB
This is a controlled, prospective, post-market clinical follow-up study that aims to collect additional data on performance and safety of the CE-marked eHeatlh system Previct Drugs. Previct Drugs is intended to be used in treatment of substance use disorder (SUD) to support and monitor patients' treatment. The system relies on self-administered eye scanning performed with a mobile phone application where the analysis of the eye´s reaction on intake of drug substances gives an indication of different drug substances. The clinical data collected in this study is an important step to verify and improve the algorithms of Previct Drugs, and to improve the mathematical models for indicating the use of the substances cannabinoids and phenethylamines. Drug intake will in this study be simulated by a controlled single application of commonly used medicines from cannabinoids and phenethylamine. The study will enroll and follow 30 male and female healthy volunteers for participation of approximately 10 days. The study will consist of two visits to the clinic, and one follow-up telephone call before the participant has completed the study. Baseline data will be collected at the first visit on Day 0, including usage of Previct Drugs, followed by usage of Previct Drugs in the home environment for about one week. At visit 2 on Day 7, the subject will be administered with the medicine he/she has been randomized to and thereafter use Previct Drugs for up to 5 hours. A final follow-up telephone call will take place approximately at day 10 before the participant has completed the study.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
